Activities of Dagmar ROTH-BEHRENDT related to 2012/0267(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices PDF (1 MB) DOC (1 MB)
Amendments (124)
Amendment 78 #
Proposal for a regulation
Recital 8
Recital 8
(8) In order to ensure consistent classification across all Member States, it should be the responsibility of the Member StatesCommission to decide on a case-by-case basis whether or not a product or groups of products falls within the scope of this Regulation. If necessary, the Commission may decide, on a case-by- case basis, whether or not a product falls and within the definition of an in vitro diagnostic medical device or of an accessory to an in vitro diagnostic medical device.
Amendment 79 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) A multidisciplinary advisory committee of experts and representatives of stakeholder and civil society organisations should be set up in accordance with the conditions and modalities defined in Article 78a of Regulation (EU) [Ref. of future Regulation on medical devices] in order to provide scientific advice to the Commission, the Medical Device Coordination Group (MDCG) and Member States on issues of in vitro diagnostic medical technology, classification and other aspects of implementation of this Regulation as necessary.
Amendment 87 #
Proposal for a regulation
Recital 28
Recital 28
(28) Transparency and better informationadequate access to information, appropriately presented for the intended user, are essential to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
Amendment 88 #
Proposal for a regulation
Recital 29
Recital 29
(29) One key aspect is the creation of a central database that should integrate different electronic systems, with the UDI as an integral part of it, to collate and process information regarding in vitro diagnostic medical devices on the market and the relevant economic operators, marketing authorisations, certificates, interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies, vigilance and market surveillance. The objectives of the database are to enhance overall transparency, via better access to information for the public and healthcare professionals, to streamline and facilitate the flow of information between economic operators, the Agency, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission, to avoid multiple reporting requirements and to enhance the coordination between Member States. Within an internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices (Eudamed) by further developing the databank set up by Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices.
Amendment 90 #
Proposal for a regulation
Recital 30
Recital 30
(30) Eudamed’s electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public and healthcare professionals to be adequately informed about devices on the Union market. Adequate levels of access for the public and healthcare professionals to those parts of Eudamed’s electronic systems which provide key information on in vitro diagnostic medical devices that may pose a risk to public health and safety is essential. Where such access is limited, it should be possible, upon a reasoned request, to disclose existing information for in vitro diagnostic medical devices, unless the limitation of access is justified on grounds of confidentiality. The electronic system on clinical performance studies should serve as tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and, in this case, to report serious adverse events. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities.
Amendment 92 #
Proposal for a regulation
Recital 32
Recital 32
(32) For high-risk in vitro diagnostic medical devices, manufacturers should summarise the main safety and performance aspects of the device and the outcomeprovide the national authority or the Agency, as relevant, involved in the marketing authorisation procedure, with a full report ofn the clinical evaluation in a document thasafety and clinical performance aspects of that device. A summary of that report should be publicly available via Eudamed.
Amendment 93 #
Proposal for a regulation
Recital 35
Recital 35
Amendment 96 #
Proposal for a regulation
Recital 35 a (new)
Recital 35 a (new)
(35a) The conformity assessment procedure should not be applicable for class D in vitro diagnostic medical devices. A swift centralized marketing authorization procedure should be introduced for innovative class D devices. A swift decentralized marketing authorization procedure should be introduced for all other class D devices, with the possibility for manufacturers of those types of devices to rather apply to the centralized marketing authorization procedure.
Amendment 98 #
Proposal for a regulation
Recital 38
Recital 38
(38) The conformity assessment procedure for class A in vitro diagnostic medical devices should be carried out, as a general rule, under the sole responsibility of the manufacturers, since such devices pose a low risk to patients. For in vitro diagnostic medical devices in classes B, C and D,C the involvement of a notified body should be compulsory to the appropriate degree. For in vitro diagnostic medical devices in class D, the involvement of the Agency or of the Member States should be compulsory.
Amendment 100 #
Proposal for a regulation
Recital 44 a (new)
Recital 44 a (new)
(44a) An interventional clinical performance studies or any other clinical performance study should only start after being granted a positive evaluation by an independent ethics committee. Member States should take the necessary measures to establish Ethics Committees where such committees do not exist.
Amendment 101 #
Proposal for a regulation
Recital 45
Recital 45
(45) Sponsors of interventional clinical performance studies and other clinical performance studies involving risks for the subjects to be conducted in more than one Member State should be given the possibility to submit a single application in order to reduce administrative burden. In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety related aspects of the device for performance evaluation and of the scientific design of the clinical performance study to be conducted in several Member Stats, such single application should facilitate the coordination between the Member States under the direction of a coordinating Member State. The coordinated assessment should not include the assessment of intrinsically national, local and ethical aspects of a clinical performance study, including informed consent. Each Member State should retain the ultimate responsibility for deciding whether the clinical performance study may be conducted on its territory.
Amendment 103 #
Proposal for a regulation
Recital 49
Recital 49
(49) Member States should take all necessary measures to raise awareness among healthcare professionals, users and patients about the importance of reporting suspected serious incidents. Healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats. TIn order to minimise the recurrence of such incidents, the national competent authorities should inform manufacturers and sharereport the information with their peersvia the respective electronic system in Eudamed when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents.
Amendment 104 #
Proposal for a regulation
Recital 53
Recital 53
(53) The Member States shall levy fees for the designation and monitoring of notified bodies to ensure sustainability of the monitoring of those bodies by Member States and to establish a level playing field for notified bodies. These fees should be comparable across Member States and should be made public.
Amendment 105 #
Proposal for a regulation
Recital 54
Recital 54
(54) Whilst this Regulation should not affect the right of the Member States to levy fees for activities at national level, Member States should inform the Commission and the other Member States before they adopt the comparable level and structure of the fees to ensure transparency.
Amendment 106 #
Proposal for a regulation
Recital 54 a (new)
Recital 54 a (new)
(54a) Member States should adopt regulations on standard fees for notified bodies, which should be comparable across Member States. The Commission should provide guidelines to facilitate the comparability of those fees. Member States should transmit their list of standard fees to the Commission and ensure that the notified bodies registered on their territory make the lists of standard fees for their conformity assessment activities publicly available.
Amendment 107 #
Proposal for a regulation
Recital 55
Recital 55
(55) An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated by the Member States, based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices, should be established in accordance with the conditions and modalities defined in Article 78 of Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices, to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation.
Amendment 135 #
Proposal for a regulation
Chapter 2 – title
Chapter 2 – title
Chapter II Chapter VI Making available of devices, obligations of economic operators, CE marking, free movement
Amendment 184 #
Proposal for a regulation
Chapter 3 – title
Chapter 3 – title
Chapter III Chapter VII Identification and traceability of devices, registration of devices and of economic operators, summary of safety and performance, European databank on medical devices
Amendment 196 #
Proposal for a regulation
Article 26 – paragraph 6 – subparagraph 1
Article 26 – paragraph 6 – subparagraph 1
The national authority responsible for notified bodies shall have a sufficient number of permanent and competent personnel at its disposal for the proper performance of its tasks"in house" for the proper performance of its tasks. Compliance with that requirement shall be assessed in the peer-review referred to in paragraph 8. In particular, the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out product related reviews shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3.2.5. of Annex VI. Similarly, the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out audits of the manufacturer’s quality management system shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3.2.6. of Annex VI.
Amendment 197 #
Proposal for a regulation
Article 26 – paragraph 6 – subparagraph 2
Article 26 – paragraph 6 – subparagraph 2
Without prejudice to Article 31(3), where a national authority is responsible for the designation of notified bodies in the field of products other than in vitro diagnostic medical devices, the competent authority for in vitro diagnostic medical devices shall be consulted on all aspects specifically related to such devices.
Amendment 199 #
Proposal for a regulation
Article 26 – paragraph 7
Article 26 – paragraph 7
7. Member States shall provide the Commission and the other Member States with all information they request on their procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto.
Amendment 201 #
Proposal for a regulation
Article 26 – paragraph 8 – subparagraph 2
Article 26 – paragraph 8 – subparagraph 2
The Member States shall draw up the annual plan for the peer-review, ensuring an appropriate rotation in respect of reviewing and reviewed authorities, and submit it to the Commission. The Commission mayshall participate in the review. The outcome of the peer-review shall be communicated to all Member States and to the Commission and a summary of the outcome shall be made publicly available.
Amendment 202 #
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Notified bodies shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this Regulation. Minimum requirements to be met by notified bodies are set out in Annex VIIn this respect, permanent "in house" administrative, technical and scientific personnel, with pharmacological, medical and technical knowledge is crucial. Minimum requirements to be met by notified bodies are set out in Annex VI. In particular, in accordance with point 1.2. of Annex VI, the notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities and avoid conflict of interests.
Amendment 203 #
Proposal for a regulation
Article 28 – paragraph 1
Article 28 – paragraph 1
1. Where a nNotified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the relevant requirements sehall have permanent "in house" competent personnel and expertise, both in technical fields linked with the assessment of the performance of the devices, and in the medical field. They shall have the capacity to evaluate "in house" the quality of subcontractors. Subcontracting shall be awarded to public entities. Contracts can also be awarded to external experts for the assessment outf in Annex VI and shall infnovative medical devices orm the national authority responsible for notified bodies accordinglyechnologies where clinical expertise is limited.
Amendment 204 #
Proposal for a regulation
Article 28 – paragraph 1 a (new)
Article 28 – paragraph 1 a (new)
1a. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the relevant requirements set out in Annex VI and shall inform the national authority responsible for notified bodies accordingly.
Amendment 205 #
Proposal for a regulation
Article 28 – paragraph 2 a (new)
Article 28 – paragraph 2 a (new)
2a. Notified bodies shall make publicly available the list of subcontractors or subsidiaries, as well as the specific tasks for which they are responsible.
Amendment 206 #
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Conformity assessment activities may be subcontracted or carried out by a subsidiary only with the explicit agreement of the legal or natural person that applied for conformity assessment.
Amendment 207 #
Proposal for a regulation
Article 28 – paragraph 4
Article 28 – paragraph 4
4. Notified bodies shall keep at the disposal ofAt least once a year, notified bodies shall submit to the national authority responsible for notified bodies the relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.
Amendment 212 #
Proposal for a regulation
Article 30 – paragraph 4 – subparagraph 2
Article 30 – paragraph 4 – subparagraph 2
Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in Annex VI shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application. Divergent opinions shall be identified in the assessment report of the national authority responsible. The national authority shall set out in the assessment report the measures it will take to ensure compliance of that applicant conformity assessment body with the requirements set out in Annex VI.
Amendment 214 #
Proposal for a regulation
Article 30 – paragraph 6
Article 30 – paragraph 6
6. The joint assessment team shall provide its opinion regarding the assessment report and the draft notification within 21 days of receipt of those documents and the Commission shall immediately submit this opinion to the MDCG. Within 21 days after receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft notification which t. The relevant national authority shall duly take into consideration for its decision on the designation of the notified bodybase its decision on the designation of the notified body on this recommendation by the MDCG. In case where its decision differs from that recommendation, the national authority shall provide the MDCG with all necessary justifications.
Amendment 215 #
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. Member States mayshall notify only conformity assessment bodies which satisfy the requirements set out in Annex VI.
Amendment 216 #
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
Amendment 218 #
Proposal for a regulation
Article 31 – paragraph 8
Article 31 – paragraph 8
8. When a Member State or the Commission raises objections in accordance with paragraph 7, the effect of the notification shall be immediately suspended. In this case, the Commission shall bring the matter before the MDCG within 15 days after expiry of the period referred to in paragraph 7. After consulting the parties involved, the MDCG shall give its opinion at the latest within 28 days after the matter has been brought before it. If the notifying Member State does not agree with the opinion of the MDCG, it may request the Commission to give its opinion.
Amendment 220 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. The Commission shall make easily accessible to the public the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date.
Amendment 221 #
Proposal for a regulation
Article 33 – paragraph 1 – subparagraph 2
Article 33 – paragraph 1 – subparagraph 2
Notified bodies shall, without delay, and at least within 15 days, inform the national authority responsible for notified bodies of any changes, in particular regarding their personnel, facilities, subsidiaries or subcontractors, which may affect compliance with the requirements set out in Annex VI or their ability to conduct the conformity assessment procedures relating to the devices for which they have been designated.
Amendment 222 #
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. Notified bodies shall respond without delay, and at least within 15 days, to requests relating to conformity assessments they have carried out, submitted by their or another Member State’s authority or by the Commission. The national authority responsible for notified bodies of the Member State in which the body is established shall enforce requests submitted by authorities of any other Member State or by the Commission unless. Where there is a legitimate reason for not doing so in which case both sides may consult the MDCG. The notified body or their national authority responsible for notified bodies may request that any information transmitted to the authorities of another Member State or to the Commission shall be treated as confidential, the notified bodies shall explain these reasons and shall consult the MDCG, which shall then issue a recommendation. The national authority responsible for notified bodies shall comply with the MDCG’s recommendation.
Amendment 225 #
Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 2
Article 34 – paragraph 2 – subparagraph 2
The national authority responsible for notified bodies shall immediately and at least within 10 days, inform the Commission and the other Member States of any suspension, restriction or withdrawal of a notification.
Amendment 226 #
Proposal for a regulation
Article 34 – paragraph 4
Article 34 – paragraph 4
4. The national authority responsible for notified bodies shall assess whether the reasons which gave rise to the change to the notification have an impact on the certificates issued by the notified body and, within three months after having notified the changes to the notification, shall submit a report on its findings to the Commission and the other Member States. Where necessary to ensure the safety of devices on the market, that authority shall instruct the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, and at the latest 30 days after the publication of the report, any certificates which were unduly issued. If the notified body fails to do so within the determined period of time, or has ceased its activity, the national authority responsible for notified bodies itself shall suspend or withdraw the certificates unduly issued.
Amendment 227 #
Proposal for a regulation
Article 34 – paragraph 5 – subparagraph 2
Article 34 – paragraph 5 – subparagraph 2
The authority or the notified body assuming the functions of the notified body affected by the change of notification shall immediately and at least within 10 days, inform the Commission, the other Member States and the other notified bodies thereof.
Amendment 230 #
Proposal for a regulation
Article 37 – paragraph 1
Article 37 – paragraph 1
The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies referred to in Article 39 of Regulation [Ref. of future Regulation on medical devices]. This group shall meet on a regular basis and at least twice a year.
Amendment 234 #
Proposal for a regulation
Article 38 – title
Article 38 – title
Fees for the activities of national authorities
Amendment 235 #
Proposal for a regulation
Article 38 – paragraph 1
Article 38 – paragraph 1
1. The Member State where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation. These fees shall be comparable across Member States and the level of the fees shall be made public.
Amendment 236 #
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 setting out the structure and the comparable level of the fees referred to in paragraph 1, taking into account the objectives of protection of human health and safety, support of innovation and, cost- effectiveness and the need to create a level-playing field across Member States. Particular attention shall be paid to the interests of notified bodies that received a certificate delivered by the national accreditation body as referred to in Article 29(2) and notified bodies that are small and medium-sized enterprises as defined by the Commission Recommendation 2003/361/EC.
Amendment 237 #
Proposal for a regulation
Article 38 a (new)
Article 38 a (new)
Article 38a Transparency on fees charged by notified bodies for conformity assessment activities 1. Member States shall adopt regulations on standard fees for notified bodies. 2. Fees shall be comparable across Member States. The Commission shall provide guidelines to facilitate comparability of those fees within 24 months from the date of entry into force of this Regulation. 3. Member States shall transmit their list of standard fees to the Commission. 4. The national authority shall ensure that the notified bodies make the lists of standard fees for the conformity assessment activities publicly available.
Amendment 240 #
Proposal for a regulation
Chapter 5 – title
Chapter 5 – title
Classifichapter V Chapter III Marketing authorisation and conformity assessment
Amendment 241 #
Proposal for a regulation
Chapter 5 – section 1 – title
Chapter 5 – section 1 – title
Amendment 242 #
Proposal for a regulation
Chapter 5 – section 1 a – Article 39 a (new)
Chapter 5 – section 1 a – Article 39 a (new)
Section 1a – Marketing authorisation Article 39 a (new) General principles regarding the marketing authorisation 1. None of the innovative class D devices may be placed on the market within the Union unless a Union marketing authorisation has been granted through the centralised procedure referred to in Article 39c, and in accordance with the provisions of this Regulation. 2. None of the non-innovative class D devices may be placed on the market of a Member State unless a national marketing authorisation has been granted by the competent authority of that Member State through the decentralised procedure referred to in Article 39d, and in accordance with the provisions of this Regulation. 3. By way of derogation from paragraph 2, the manufacturer may decide to apply for a marketing authorisation under the centralised procedure for the devices included in paragraph 2. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to amend the list set out in paragraph 1, in the light of technical progress. 5. Devices referred to in paragraphs 1 and 2, and which are already on the Union market at the date of entry into force of this Regulation, shall be required to have a marketing authorisation, in accordance with the procedures set out in this Section, as from the expiry date of the validity of their certificate. 6. A marketing authorisation granted under this Section shall be valid for five years. The marketing authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the Agency. 7. All applications for marketing authorisation and granted marketing authorisations under the provisions of Articles 39c, 39d, 39e and 39f as well as the information referred to in Article 39b shall be entered either by the Commission or the Member States, as relevant, in the electronic system referred to in Article 39b(1), without delay and at the latest 15 days after receipt. Before commencing the review of an application for a medical device, the Committee for the Authorisation of Medical Devices, as referred to in Article 41c, or the competent authority of the relevant Member State shall verify that no other application has been introduced for the same medical device.
Amendment 243 #
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 b (new)
Chapter 5 – Section 1 a – Article 39 b (new)
Amendment 244 #
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 c (new)
Chapter 5 – Section 1 a – Article 39 c (new)
Amendment 245 #
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 d (new)
Chapter 5 – Section 1 a – Article 39 d (new)
Amendment 246 #
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 e (new)
Chapter 5 – Section 1 a – Article 39 e (new)
Amendment 247 #
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 f (new)
Chapter 5 – Section 1 a – Article 39 f (new)
Amendment 248 #
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 g (new)
Chapter 5 – Section 1 a – Article 39 g (new)
Amendment 249 #
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 h (new)
Chapter 5 – Section 1 a – Article 39 h (new)
Amendment 257 #
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 1
Article 40 – paragraph 2 – subparagraph 1
Manufacturers of devices classified as class D, other than devices for performance evaluation, shall be subject to a conformity assessmentmarketing authorisation based on full quality assurance, design dossier examination and batch verification, as specified in Annex VIII. Alternatively, the manufacturer may choose to apply a conformity assessmentmarketing authorisation based on type examination as specified in Annex IX, coupled with a conformity assessmentmarketing authorisation based on production quality assurance including batch verification, as specified in Annex X.
Amendment 258 #
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 2
Article 40 – paragraph 2 – subparagraph 2
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessmentCommittee for the Authorisation of In Vitro Diagnostic Medical Device referred to in Article 39c, or the national authority, shall request that reference laboratory to verify compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX.
Amendment 261 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1
Article 40 – paragraph 3 – subparagraph 1
Amendment 263 #
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1
Article 40 – paragraph 4 – subparagraph 1
Amendment 264 #
Proposal for a regulation
Article 40 – paragraph 5 – subparagraph 1
Article 40 – paragraph 5 – subparagraph 1
Amendment 265 #
Proposal for a regulation
Article 40 – paragraph 6
Article 40 – paragraph 6
6. Manufacturers may choose to apply a marketing authorisation or a conformity assessment procedure applicable to devices of a higher class than the device in question.
Amendment 266 #
Proposal for a regulation
Article 40 – paragraph 9 – subparagraph 1 – indent 3
Article 40 – paragraph 9 – subparagraph 1 – indent 3
Amendment 267 #
Proposal for a regulation
Article 41 – title
Article 41 – title
Involvement of notified bodies in the conformity assessment procedure
Amendment 268 #
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of his choice, provided that the body is notified for the conformity assessment activities, the conformity assessment procedures and the devices concerned. Where a manufacturer applies to a notified body located in a Member State other than the one where it is registered, the manufacturer shall inform its national authority responsible for the notified bodies of the application. An application may not be lodged in parallel with more than one notified body for the same conformity assessment activity.
Amendment 271 #
Proposal for a regulation
Article 42
Article 42
deleted
Amendment 275 #
Proposal for a regulation
Article 44 – paragraph 1 – introductory part
Article 44 – paragraph 1 – introductory part
1. In cases wWhere a manufacturer decides to terminates his contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, tit shall inform its national authority responsible for the notified bodies of this change. The modalities of the change of notified body shall be clearly defined in an agreement between the manufacturer, the outgoing notified body and the incoming notified body. This agreement shall address at least the following aspects:
Amendment 277 #
Proposal for a regulation
Chapter 6 – title
Chapter 6 – title
Chapter VI Chapter V Clinical evidence Clinical evidence
Amendment 278 #
Proposal for a regulation
Article 48 – paragraph 1 – point b
Article 48 – paragraph 1 – point b
(b) to verify that devices achieve the intended benefits to the patient as specified by the manufacturere clinical safety and efficacy of the device, including the intended benefits to the patient, when used for the intended purpose, in the target population and in accordance with the instructions of use;
Amendment 279 #
Proposal for a regulation
Article 48 – paragraph 4
Article 48 – paragraph 4
4. All clinical performance studies shall be designed and conducted in a way that the rights, safety and well-being of the subjects participating in such clinical performance studies are protected, in accordance with Article 48 a (3), and that the clinical data generated in the clinical performance study are going to be reliable and robust.
Amendment 280 #
Proposal for a regulation
Article 48 a (new)
Article 48 a (new)
Article 48 a Involvement of Ethics Committee 1. Authorisation to conduct a clinical performance study may only be granted if an independent ethics committee has previously submitted a positive evaluation of that performance study. 2. The statement of the Ethics Committee shall cover in particular the medical justification, the consent of the test subjects participating in the clinical performance study following the provision of full information about the clinical performance study and the suitability of the investigators and investigation facilities. 3. The Ethics Committee shall ensure that the rights, safety and well-being of subjects participating in a clinical performance study are protected. 4. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and must abide by all relevant international norms and standards. 5. The Ethics Committee shall consist of a clearly defined number of members and substitutes which include healthcare professionals, laypersons and at least one well-experienced, knowledgeable patient or patient representative, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed clinical performance study. 6. Member States shall take the necessary measures to establish Ethics Committees where such committees do not exist, and to facilitate their work. Members States shall publish the number, the names and the professions of the members and substitutes of the Ethics Committees and inform the Commission about the composition of the Ethics Committees and the date on which they become operational.
Amendment 281 #
Proposal for a regulation
Article 49 – paragraph 2 – subparagraph 1
Article 49 – paragraph 2 – subparagraph 1
The sponsor of a clinical performance study shall submit an application to the Member State(s) in which the study is to be conducted accompanied by the documentation referred to in Annex XIII. Within sixten days after receipt of the application, the Member State concerned shall notify the sponsor whether the clinical performance study falls within the scope of this Regulation and whether the application is complete.
Amendment 283 #
Proposal for a regulation
Article 49 – paragraph 3 – subparagraph 1
Article 49 – paragraph 3 – subparagraph 1
Where the Member State finds that the clinical performance study applied for does not fall within the scope of this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a maximum of sixten days for the sponsor to comment or to complete the application.
Amendment 284 #
Proposal for a regulation
Article 49 – paragraph 3 – subparagraph 3
Article 49 – paragraph 3 – subparagraph 3
Where the Member State has not notified the sponsor according to paragraph 2 within threfive days following receipt of the comments or of the completed application, the clinical performance study shall be considered as falling within the scope of this Regulation and the application shall be considered complete.
Amendment 285 #
Proposal for a regulation
Article 49 – paragraph 5 – point c
Article 49 – paragraph 5 – point c
(c) after the expiry of 3560 days after the validation date referred to in paragraph 4, unless the Member State concerned has notified the sponsor within that period of its refusal based on considerations of public health, patient safety or public policy.
Amendment 286 #
Proposal for a regulation
Article 50 – paragraph 1 – point g a (new)
Article 50 – paragraph 1 – point g a (new)
(g a) the methodology to be used, the number of subjects involved and the intended result of the study.
Amendment 287 #
Proposal for a regulation
Article 50 – paragraph 2 a (new)
Article 50 – paragraph 2 a (new)
2a. Upon completion of the clinical performance study, the sponsor shall enter in the electronic system referred to in Article 51 a summary of its results drawn up in a way that is easy for a lay person to understand.
Amendment 295 #
Proposal for a regulation
Article 51 – paragraph 2
Article 51 – paragraph 2
2. When setting up the electronic system referred in paragraph 1, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article […] of Regulation (EU) No [Ref. of future Regulation on clinical trials]. With the exception of the information referred to in Article 50, the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission. The Commission shall also ensure that healthcare professionals have access to the electronic system.
Amendment 297 #
Proposal for a regulation
Article 51 – paragraph 2 a (new)
Article 51 – paragraph 2 a (new)
2a. Upon a reasoned request, all information on a specific in vitro diagnostic medical device available in the electronic system shall be made accessible to the party requesting it, save where the confidentiality of all or parts of the information is justified on any of the following grounds: (a) protection of personal data in accordance with Regulation (EC) No 45/2001; (b) protection of commercially sensitive information; (c) effective supervision of the conduct of the clinical performance study by the Member State(s) concerned.
Amendment 298 #
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Where a Member State has refused, suspended or terminated a clinical performance study, or has called for a substantial modification or temporary halt of a clinical performance study, or has been notified by the sponsor of the early termination of a clinical performance study on safety or efficacy grounds, that Member State shall communicate its decision and the grounds thereforfor that decision to all Member States and the Commission by means of the electronic system referred to in Article 51.
Amendment 299 #
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
1. If the sponsor has temporarily halted a clinical performance study on safety or efficacy grounds, he shall inform the Member States concerned within 15 days of the temporary halt.
Amendment 300 #
Proposal for a regulation
Article 55 – paragraph 2 – subparagraph 1
Article 55 – paragraph 2 – subparagraph 1
The sponsor shall notify each Member State concerned of the end of a clinical performance study in relation to that Member State, providing a justification in the event of early termination, so that all Member States can inform sponsors conducting similar clinical performance studies at the same time within the Union of the results of that clinical performance study. That notification shall be made within 15 days from the end of the clinical performance study in relation to that Member State.
Amendment 301 #
Proposal for a regulation
Article 55 – paragraph 2 – subparagraph 2
Article 55 – paragraph 2 – subparagraph 2
If the study is conducted in more than one Member State, the sponsor shall notify all Member States concerned of the overall end of the clinical performance study. Information on the reasons for the early termination of the clinical performance study shall also be provided to all Member States, so that all Member States can inform sponsors conducting similar clinical performance studies at the same time within the Union of the results of that the clinical performance study. That notification shall be made within 15 days from the overall end of the clinical performance study.
Amendment 303 #
Proposal for a regulation
Article 56 – paragraph 2
Article 56 – paragraph 2
2. In the single application, the sponsor shall propose one of the Member States concerned as coordinating Member State. The reporting Member State shall be chosen from among the Member States concerned in which most of the subjects participating in the clinical performance study in question live. If that Member State does not wish to be the coordinating Member State, it shall agree, within six days of submission of the single application, with another Member State concerned that the latter shall be the coordinating Member State. If no other Member State accepts to be the coordinating Member State, the Member State proposed by the sponsor shall be the coordinating Member State. If another Member State than the one proposed by the sponsor becomes coordinating Member State, the deadlines referred to in Article 49(2) shall start on the day following the acceptance.
Amendment 305 #
Proposal for a regulation
Chapter 7 – title
Chapter 7 – title
Chapter VII Chapter VIII Vigilance and market surveillance
Amendment 306 #
Proposal for a regulation
Article 59 – paragraph 1 – subparagraph 1 – point a
Article 59 – paragraph 1 – subparagraph 1 – point a
(a) any serious incident ,including date and place of incident, in respect of devices made available on the Union market; where available, the manufacturer shall include information on the patient or user and healthcare professional involved in the incident;
Amendment 308 #
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures, including targeted information campaigns, to encourage healthcare professionals, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure thatinform the manufacturer of the device concerned is informed of the incidentwithout delay. The manufacturer shall ensure the appropriate follow-up. Where a competent authority of a member State ascertains that the reports received pursuant to the first subparagraph relate to a serious incident it shall notify those reports to the electronic system referred to in Article 60 without delay, unless the same incident has already been reported by the manufacturer.
Amendment 311 #
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 2
Article 59 – paragraph 3 – subparagraph 2
The Member States shall coordinate between them theCommission, in cooperation with the Member States and in consultation with relevant partners including patient and consumer organisations, shall development of standard web-based structured forms for forms for electronic and non- electronic reporting of serious incidents by healthcare professionals, users and patients.
Amendment 314 #
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – paragraph 2
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission and, to the Agency, to the notified bodies and healthcare professionals..
Amendment 315 #
Proposal for a regulation
Article 60 – paragraph 3
Article 60 – paragraph 3
3. The Commission shall ensure that healthcare professionals and the public havehas an appropriate levels of access to the electronic system. In particular, it shall ensure that, in case information is requested on a specific in vitro diagnostic medical device, it is made available without delay and within 15 days.
Amendment 316 #
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 2
Article 61 – paragraph 1 – subparagraph 2
Amendment 318 #
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
2. The information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and be accessible to the Member States and to the Commission, to the Commission, to the Agency and to healthcare professionals. The Commission shall also ensure that the public has an appropriate level of access to the electronic system. In particular, it shall ensure that, in case information is requested on a specific in vitro diagnostic medical device, it is made available without delay and within 15 days..
Amendment 319 #
Proposal for a regulation
Chapter 8 – title
Chapter 8 – title
Chapter VIII Chapter IX Cooperation between Member States, Medical Device Coordination Group, EU reference laboratories, device registers
Amendment 320 #
Proposal for a regulation
Article 77 – paragraph 1 – point a a (new)
Article 77 – paragraph 1 – point a a (new)
(aa) to examine questions related to the mutual recognition procedure in accordance with provisions under Article 39e;
Amendment 330 #
Proposal for a regulation
Article 77 a (new)
Article 77 a (new)
Amendment 338 #
Proposal for a regulation
Article 79 – paragraph 1
Article 79 – paragraph 1
The Commission and the Member States shall take all appropriate measures to encouragsure the establishment of registers for specific types ofin vitro diagnostic devices to gather post- market experience related to the use of such devices. registers for class C and D shall be systematically established. Such registers shall contribute to the independent evaluation of the long-term safety and performance of devices.
Amendment 339 #
Proposal for a regulation
Chapter 9 – title
Chapter 9 – title
Chapter IX Chapter X Confidentiality, data protection, funding, penalties
Amendment 340 #
Proposal for a regulation
Article 82 – paragraph 1
Article 82 – paragraph 1
This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is comparable and set in a transparent manner and on the basis of cost recovery principles. They shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted.
Amendment 343 #
Proposal for a regulation
Chapter 10 – title
Chapter 10 – title
Chapter X Chapter XI Final provisions Final provisions
Amendment 344 #
Proposal for a regulation
Article 90 – paragraph 2
Article 90 – paragraph 2
2. It shall apply from [fivthree years after entry into force].
Amendment 349 #
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.2 – paragraph 1 – point xv
Annex 1 – part III – point 17 – point 17.2 – paragraph 1 – point xv
(xv) If the device is intended for single use, an indication of that fact. The manufacturer shall provide sufficient evidence that the device cannot be reprocessed safely. A manufacturer's indication of single use shall be consistent across the Union;
Amendment 352 #
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point xii – indent 5
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point xii – indent 5
– if the device is intended for single use, an indication of that fact. The manufacturer shall provide sufficient evidence that the device cannot be reprocessed safely. A manufacturer's indication of single use shall be consistent across the Union;
Amendment 353 #
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point xii – indent 6
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point xii – indent 6
– if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, decontamination, packaging, the maximum number of allowable reuses and, where appropriate, the validated method of re- sterilization. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses.
Amendment 360 #
Proposal for a regulation
Annex 6 – point 1 – point 1.1 – point 1.1.4 – paragraph 1
Annex 6 – point 1 – point 1.1 – point 1.1.4 – paragraph 1
The organisational structure and the functions, responsibilities and authority of its top-level management and of other personnel with influence upon the performance and results of the conformity assessment activities shall be clearly documented. This information shall be made publicly available.
Amendment 361 #
Proposal for a regulation
Annex 6 – point 1 – point 1.2 – point 1.2.3 a (new)
Annex 6 – point 1 – point 1.2 – point 1.2.3 a (new)
1.2.3 a. The notified body shall provide evidence to the national authority that there are no conflicts of interest in compliance with point 1.2.3. The national authority shall report to the Commission twice a year in full transparency.
Amendment 362 #
Proposal for a regulation
Annex 6 – point 1 – point 1.2 – point 1.2.6
Annex 6 – point 1 – point 1.2 – point 1.2.6
1.2.6. The notified body shall ensure and document that the activities of its subsidiaries or subcontractors, or of any associated body, do not affect its independence, impartiality or objectivity of its conformity assessment activities. The notified body shall provide evidence to the national authority of its compliance with this point.
Amendment 363 #
Proposal for a regulation
Annex 6 – point 1 – point 1.3 – paragraph 1
Annex 6 – point 1 – point 1.3 – paragraph 1
The personnel of a notified body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, only in justified cases and except in relation to the national authorities responsible for notified bodies, competent authorities or the Commission. Proprietary rights shall be protected. To this end, the notified body shall have documented procedures in place. Where information and data are requested by the public or healthcare professionals, the notified body shall make publicly available the reasons for such information being subject to non- disclosure.
Amendment 364 #
Proposal for a regulation
Annex 6 – point 1 – point 1.6 – point 1.6.1
Annex 6 – point 1 – point 1.6 – point 1.6.1
1.6.1. The notified body shall participate in, or ensure that its assessment personnel is informed of the relevant standardisation activities and the activities of the notified body coordination group and that its assessment and decision making personnel are informed of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation. The notified body shall keep a record of the actions it takes to inform its personnel.
Amendment 365 #
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 2
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 2
This presupposes the permanent availability within its organisation of sufficient scientific personnel who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Regulation and, in particular, those set out in Annex I.
Amendment 366 #
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.2
Annex 6 – point 3 – point 3.1 – point 3.1.2
3.1.2. At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a notified body shall have within its organisation the necessary administrative, technical and scientific personnel with pharmacological, medical and technical knowledge and sufficient and appropriate experience relating to in vitro diagnostic medical devices and the corresponding technologies to perform the conformity assessment tasks, including the assessment of clinical data.
Amendment 367 #
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.3 a (new)
Annex 6 – point 3 – point 3.1 – point 3.1.3 a (new)
3.1.3 a. The notified body shall make available the list of its personnel and their expertise to the Commission and, upon request, to other parties. That list shall be kept up to date.
Amendment 368 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.3 – indent 7 a (new)
Annex 6 – point 3 – point 3.2 – point 3.2.3 – indent 7 a (new)
- at least three years' appropriate experience in the field of conformity assessments within a notified body,
Amendment 369 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – introductory part
Annex 6 – point 3 – point 3.2 – point 3.2.4 – introductory part
3.2.4. NClinical experts: notified bodies shall have available personnel with clinical expertise, on a permanent basis, personnel with expertise in clinical investigation design, medical statistics, clinical patient management, Good Clinical Practice in the field of clinical performance studies and pharmacology. This personnel shall be integrated in the notified body's decision-making process in a steady way in order to:
Amendment 370 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 1
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 1
– identify when specialist input is required for the assessment of the clinical performance studies plans and the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts;
Amendment 371 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 3
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 3
– be able to discuss the clinical data contained within the manufacturer's clinical evaluarationale of the planned study design, the clinical performance study plans and the selection of the control intervention with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation;
Amendment 372 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 4
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 4
– be able to scientifically challenge the clinical performance study plans and the clinical data presented, and the results of the external clinical experts' assessment of the manufacturer's clinical evaluation;
Amendment 373 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 6 a (new)
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 6 a (new)
- provide an understanding of active substances.
Amendment 374 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.5 – introductory part
Annex 6 – point 3 – point 3.2 – point 3.2.5 – introductory part
3.2.5. TProduct assessors: the personnel responsible for carrying out product related review (e.g. design dossier review, technical documentation review or type examination including aspects such as clinical evaluation, sterilisation, software validation) shall have the following proven qualification:
Amendment 376 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.6 – introductory part
Annex 6 – point 3 – point 3.2 – point 3.2.6 – introductory part
3.2.6. TAuditors: the personnel responsible for carrying out audits of the manufacturer's quality management system shall have the following proven qualification:
Amendment 378 #
Proposal for a regulation
Annex 6 – point 3 – point 3.3 – point 3.3.1
Annex 6 – point 3 – point 3.3 – point 3.3.1
3.3.1. The notified body shall have a process in place to fully document the qualification of each personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2. Where in exceptional circumstances the fulfilment of the qualification criteria set out in Section 3.2 cannot be fully demonstrated, the notified body shall appropriately justify the authorisation of this personnel to carry out specific conformity assessment activities.
Amendment 379 #
Proposal for a regulation
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.1
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.1
3.4.1. Without prejudice to the limitations emanating from Section 3.2., the notified bodies may subcontract clearly defined parts of the conformity assessment activities(-1). Notified body shall have permanent "in house" competent personnel and expertise, not only in technical fields linked with the assessment of the performance of the devices, but also in the medical sector. They shall have the capacity to evaluate "in house" the quality of subcontractors. By derogation, the following paragraphs apply. 3.4.1. Without prejudice to the limitations emanating from Section 3.2., the notified bodies may subcontract clearly defined parts of the conformity assessment activities to public entities. Contracts can also be awarded to external experts for the assessment of innovative medical devices or technologies where clinical expertise is limited. The subcontracting of the auditing of quality management systems or of product related reviews as a whole is not allowed.
Amendment 380 #
Proposal for a regulation
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.2
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.2
3.4.2. Where a notified body subcontracts conformity assessment activities either to an organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take place. Any subcontracting or consultation of external experts shall be properly documented, be publicly available and be subject to a written agreement covering, among others, confidentiality and conflict of interests.
Amendment 381 #
Proposal for a regulation
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.4 a (new)
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.4 a (new)
3.4.4 a. The policy and procedures under points 3.4.2 and 3.4.4 shall be communicated to the national authority before any subcontracting takes place.
Amendment 382 #
Proposal for a regulation
Annex 6 – point 3 – point 3.3 – point 3.5 – point 3.5.2
Annex 6 – point 3 – point 3.3 – point 3.5 – point 3.5.2
3.5.2. It shall review the competence of its personnel and identify training needs and ensure that necessary measures are taken accordingly, in order to maintain the required level of qualification and knowledge.
Amendment 383 #
Proposal for a regulation
Annex 6 – point 4 – point 4.3 – introductory part
Annex 6 – point 4 – point 4.3 – introductory part
4.3. The notified body shall have in place documented procedures that are publicly available covering at least:
Amendment 384 #
Proposal for a regulation
Annex 6 – point 4 – point 4.3 – indent 2
Annex 6 – point 4 – point 4.3 – indent 2
– the processing of the application, including the verification of the completeness of the documentation, the qualification of the product as in vitro diagnostic medical device and its classification, as well as the minimum time for its audit assessments,