104 Amendments of Mairead McGUINNESS related to 2012/0266(COD)
Amendment 162 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) Medical devices utilised in the donation of substances of human origin and their subsequent use for treatment must conform to European Union public health legislation ensuring minimum standards for quality and safety, including Directive 2002/98/EC on minimum standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and its additional directives.
Amendment 193 #
Proposal for a regulation
Recital 44
Recital 44
(44) The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products. For medical devices in classes IIa, IIb and III, an appropriate level of involvement of a notified body shouldall be compulsory, with medical devices in class III requiring explicit prior approval of their design and manufacture before they can be placed on the market.
Amendment 200 #
Proposal for a regulation
Recital 50
Recital 50
(50) Sponsors should report certain adverse events occurring during clinical investigations to the Member States concerned, which shouldall have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation. Such information shouldall be communicated to the other Member States, the MDCG and the Commission.
Amendment 205 #
Proposal for a regulation
Recital 53
Recital 53
(53) Healthcare professionals and patients shouldall be empowered to report suspected serious incidents at national level using harmonised formats. The national competent authorities shouldall inform manufacturers and share the information with their peers, if appropriate, their subsidiaries and sub-contractors, and share the information with their peers, other Member States, the MDCG and the Commission when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents.
Amendment 208 #
Proposal for a regulation
Recital 55
Recital 55
(55) The reporting of serious adverse events during clinical investigations and the reporting of serious incidents occurring after a medical device has been placed on the market should be clearly distinguished to avoid double reporting.
Amendment 212 #
Proposal for a regulation
Recital 59 a (new)
Recital 59 a (new)
(59a) A European Medical Device Advisory Group (MDAG), composed of representatives from associations of patients, clinicians, nurses, carers and healthcare facility managers, relevant medical device manufactures and other relevant fora, chaired by a representative of the Commission, should be established to advise the MDCG on the technical, scientific, social and economic aspects of the placing on the market and availability of medical technology and related services in the Union which are conferred on it by this Regulation.
Amendment 213 #
Proposal for a regulation
Recital 61
Recital 61
(61) The Commission should provide scientific, technical and corresponding logistic support to the coordinating national authority and ensure that the regulatory system for medical devices is effectively and uniformly implemented at Union level based on sound scientific evidence.
Amendment 214 #
Proposal for a regulation
Recital 63
Recital 63
(63) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, the integrity of the person, the principle of free and informed consent, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property, as well as the Convention on Human Rights. This Regulation should be applied by the Member States in accordance with those rights and principles.
Amendment 218 #
Proposal for a regulation
Recital 64
Recital 64
(64) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the products subject to this Regulation that are similar to medical devices but do not necessarily have a medical purpose; adaptation of the definition of nanomaterial to technical progress and to developments at Union and international level; adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certificates issued by notified bodies, of the minimum requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical investigations; the establishment of the UDI system; the information to be submitted for the registration of medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical investigations; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them. However, substantial elements of this Regulation, such as general safety and performance requirements, elements to be addressed in technical documentation, the minimum content of the Union declaration of conformity, amending or supplementing the conformity assessment procedures, should only be amended through the ordinary legislative procedure. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
Amendment 221 #
Proposal for a regulation
Recital 68
Recital 68
(68) To allow economic operators, notified bodies, Member States and the Commissionespecially SMEs, to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements to be taken for its proper application. However, parts of the Regulation that affect directly Member Sates and the Commission should be implemented as soon as possible. It is particularly important that by the date of application, a sufficient number of notified bodies are designated in accordance with the new requirements to avoid any shortage of medical devices on the market. Also at the date of application, existing notified bodies that handle class III devices, shall be subject to an application for notification in accordance with Article 31.
Amendment 226 #
Proposal for a regulation
Article 1 – paragraph 2 – point f
Article 1 – paragraph 2 – point f
(f) all products that contain or consist of biological substances or organisms other than those referred to in points (c) and (e) that are viable, including living micro- organisms, bacteria, fungi or virus;
Amendment 229 #
Proposal for a regulation
Article 1 – paragraph 5 a (new)
Article 1 – paragraph 5 a (new)
5a. This Regulation shall not impede the continued application of measures within Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 and its five Daughter Directives setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components. Articles 10 (Personnel), 14 (Traceability), 15 (Notification of serious adverse events and reactions), 19 (Examination of donors) and 29 (Technical requirements and their adaptation to technical and scientific progress) of Directive 2002/98/EC ensure donor and patient safety and as such those existing standards shall be maintained.
Amendment 230 #
Proposal for a regulation
Article 1 – paragraph 7 a (new)
Article 1 – paragraph 7 a (new)
7a. The regulation of medical devices at Union level shall not interfere with the freedom of Member States to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation.
Amendment 232 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 1 – introductory part
(1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific direct or indirect medical purposes of:
Amendment 247 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 5 – indent 2 – paragraph 2
Article 2 – paragraph 1 – subparagraph 1 – point 5 – indent 2 – paragraph 2
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be considered an implantable device;, with the exception of any device intended to be placed in the teeth, which is in class IIa and therefore shall not be subject to Article 16 of this Regulation.
Amendment 254 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 19 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 19 – introductory part
(19) ‘manufacturer’ means the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name or trademark.
Amendment 255 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 19 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 19 – introductory part
(19) ‘manufacturer’ means the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under hisith the responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under that person's own name, regardless of whether those operations are carried out by that person or on that person's behalf by a third party. The obligations of this Regulation to be met by manufactures also apply to natural or legal persons who assemble, package, process, fully refurbish or label one or more ready-made products and/or assign to them their intended purpose as devices with a view to their being placed on the market under that person's own name or trademark.
Amendment 263 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 37
Article 2 – paragraph 1 – subparagraph 1 – point 37
(37) ‘sponsor’ means an individual, company, institution or organisation which takes responsibility for the initiation and management, conduct or financing of a clinical investigation;
Amendment 274 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, on its own imitative, or shall at the request of a Member State or on its own initiative, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 290 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficientthere is a need to address public health concerns, the Commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post- market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3).
Amendment 296 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Devices which are in conformity with the CTS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CTS or parts thereof. The technical content of the CTS shall be developed with the appropriate support of relevant stakeholders affected by the CTS and in such a manner so that the development of standards and guidelines is not impinged upon
Amendment 378 #
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 2
Article 14 – paragraph 1 – subparagraph 2
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in number (19) of Article 2(1), assembles or adapts a device already on the market to its intended purpose for an individual patient.
Amendment 406 #
Proposal for a regulation
Article 16 – title
Article 16 – title
Information about implantable devices and implant card
Amendment 411 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particulhealthcare patient who has beenrofessional implanted withing the device. who shall:
Amendment 416 #
Proposal for a regulation
Article 16 – paragraph 1 – indent 1 (new)
Article 16 – paragraph 1 – indent 1 (new)
- record all the information contained on the card in the patient's medical records
Amendment 417 #
Proposal for a regulation
Article 16 – paragraph 1 – indent 2 (new)
Article 16 – paragraph 1 – indent 2 (new)
- handover the card to the patient
Amendment 482 #
Proposal for a regulation
Article 28 – paragraph 5
Article 28 – paragraph 5
5. The national authority responsible for notified bodies shall safeguard the confidentiality aspects of the information it obtains. However, it shall exchange information on a notified body with other Member States and the Commission.
Amendment 484 #
Proposal for a regulation
Article 28 – paragraph 7
Article 28 – paragraph 7
7. Member States shall provide the Commission and the other Member States with information 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. Such information shall be publicly available
Amendment 502 #
Proposal for a regulation
Article 33 – paragraph 2 – subparagraph 1 (new)
Article 33 – paragraph 2 – subparagraph 1 (new)
In all cases where the applicant body claims to be competent in devices listed in class III, those implanted into the body, incorporating a substance considered to be a medicinal product, or utilising non- viable tissues or cells of human or animal origin, or their derivatives, Member States may notify only conformity assessment bodies which have been jointly assessed with the Commission, the MDCG and the national authority responsible for notified bodies of the Member State in which the applicant body is established
Amendment 507 #
Proposal for a regulation
Article 33 – paragraph 9
Article 33 – paragraph 9
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly. The full details of the notification, including annexes, shall be made publicly available.
Amendment 511 #
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. At least once a year, the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in Annex VI. This assessment shall include an on-site visit to each notified body. The assessment shall also include a review of samples of the design dossier assessments carried out by the notified body to determine the ongoing competence of the notified body and quality of its assessments, in particular the notified body's ability to evaluate and assess clinical evidence.
Amendment 517 #
Proposal for a regulation
Article 35 – paragraph 4
Article 35 – paragraph 4
4. Three years after notification of a notified body, and again every third year thereafter, the assessment to determine whether the notified body and its subsidiaries and sub contractors still satisfies the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established and a joint assessment team designated in accordance with the procedure described in Article 32(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body with the requirements set out in Annex VI. The full results of the assessments shall be published.
Amendment 518 #
Proposal for a regulation
Article 35 – paragraph 4 a (new)
Article 35 – paragraph 4 a (new)
4a. for conformity assessment bodies which are notified for Class III devices, the assessment referred to at paragraph 4 of this article shall be performed every year. The assessment shall include a review of samples of the design dossier assessments carried out by the notified body to determine the ongoing competence of the notified body and quality of its assessments, in particular the notified body's ability to evaluate and assess clinical evidence.
Amendment 522 #
Proposal for a regulation
Article 36 – paragraph 3
Article 36 – paragraph 3
3. In the event of restriction, suspension or withdrawal of a notification, the Member State shall immediately inform the Commission which shall take appropriate steps to ensure that the files of the notified body concerned are either processed by another notified body or kept available for the national authorities responsible for notified bodies and for market surveillance at their request.
Amendment 546 #
Proposal for a regulation
Article 42 – paragraph 10 – subparagraph 1 – introductory part
Article 42 – paragraph 10 – subparagraph 1 – introductory part
The Commission mayshall, by means of implementing acts, specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects:
Amendment 569 #
Proposal for a regulation
Article 44 – paragraph 1
Article 44 – paragraph 1
(-1) A Class III device shall be evaluated exclusively by a relevant notified body that has been notified for that specific category or group of class III devices. 1. Notified bodies shall notifyinform the Commission of all applications for conformity assessments for devices classified as class III, with the exception of applications to supplement or renew existing certificatesincluding applications which are subsequently withdrawn. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and, the draft summary of safety and clinical performance referred to in Article 26. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG. and the name of the clinical expert chosen for the evaluation from the list developed by the MDCG according to Article 80 g) to review the manufacturer's clinical evaluation report. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the application notice and the accompanying documents to the MDCG. 1a. The MDCG may request the notified body to submit the manufacturer's full clinical evaluation report and post market clinical follow-up plan and the report of the clinical expert. When selecting a specific file for submission, the principle of equal treatment shall be duly taken into account. 1b. The MDCG may submit comments on the manufacturer's post market clinical follow-up plan. Where the MDCG submits comments as above, the manufacturer shall respond to the MDCG's comment within 30 days. 1c. The Commission shall make a summary of the comments submitted in accordance with paragraph 3 and the outcome of the conformity assessment procedure accessible to the public. It shall not disclose any personal data or information of commercially confidential nature. 1d. The Commission shall set up the technical infrastructure for the data- exchange by an electronic means between notified bodies and MDCG for the purposes of this Article.
Amendment 576 #
Proposal for a regulation
Article 44 – paragraph 2 – subparagraph 1
Article 44 – paragraph 2 – subparagraph 1
Within 28 days of receipt of the information referred to in paragraph 1, the MDCG may request the notified body to submit a summary of the preliminary conformity assessment prior to issuing a certificate. Upon suggestion by any of its members or by the Commission, the MDCG shall decide on making such request in accordance with the procedure set out in Article 78(4). In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file for submission of a summary of the preliminary conformity assessment. from the following list: a) Monitoring of level of positive benefit to risk evidence for the category of products concerned b) Collection of data to allow the development of a CTS or call for a harmonized standard mandate from the European Commission for the category of products concerned c) Assessment of needed competence or training need of the notified body and other notified bodies for the category of products concerned d) Input into planned notified body monitoring activities e) Input into planned market surveillance activities f) Ongoing vetting of the list of clinical experts g) Planned public information campaigns When selecting a specific file for submission, the principle of equal treatment shall be duly taken into account.
Amendment 578 #
Proposal for a regulation
Article 44 – paragraph 2 – subparagraph 2
Article 44 – paragraph 2 – subparagraph 2
Amendment 588 #
Proposal for a regulation
Article 44 – paragraph 5 – subparagraph 1
Article 44 – paragraph 5 – subparagraph 1
Where deemed necessary for the protection of patient safety and public health, the Commission, may determine, by means of implementing acts, specific categories or groups of devices, other than devices of class III, to which paragraphs 1 to 4 shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 595 #
Proposal for a regulation
Article 44 – paragraph 8
Article 44 – paragraph 8
8. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the summary of the preliminary conformity assessment in accordance with paragraphs 2 and 3application of this article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 620 #
Proposal for a regulation
Article 51 – paragraph 6 – subparagraph 2
Article 51 – paragraph 6 – subparagraph 2
Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patients shall be taken into account. The list of the reviewers should be made available to the sponsor
Amendment 629 #
Proposal for a regulation
Article 58 – paragraph 1
Article 58 – paragraph 1
1. By means of the electronic system referred to in Article 53, the sponsor of a clinical investigation to be conducted in more than one Member State may submit, for the purpose of Article 51, a singlthe application that, upon receipt, is transmitted electronically to the Member States concerned.
Amendment 630 #
Proposal for a regulation
Article 58 – paragraph 3 – subparagraph 2 – point b
Article 58 – paragraph 3 – subparagraph 2 – point b
(b) establish the results of the coordinated assessment in a report to be taken into accountapproved by the other Member States concerned when deciding on the sponsor's application in accordance with Article 51(5).
Amendment 634 #
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1 – point a
Article 61 – paragraph 1 – subparagraph 1 – point a
(a) any serious incident in respect of devices made available on the Union market;
Amendment 638 #
Proposal for a regulation
Article 61 – paragraph 3 – subparagraph 1
Article 61 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage and facilitate 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 that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 641 #
Proposal for a regulation
Article 61 – paragraph 4
Article 61 – paragraph 4
4. Manufacturers of custom-made devices shall immediately report any serious incidents and field safety corrective actions referred to in paragraph 1 to the competent authority of the Member State in which the device in question has been made available.
Amendment 652 #
Proposal for a regulation
Article 63 – paragraph 1 – subparagraph 1
Article 63 – paragraph 1 – subparagraph 1
Member States shall take the necessary steps to ensure that any information regarding a seriousn incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 61 is, at national level, evaluated centrally by their competent authority, if possible together with the manufacturer.
Amendment 655 #
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
2. The national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions, taking into account criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of harm and severity of harm, clinical benefit of the device, intended and potential users, and population affected. They shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action. They shall monitor the manufacturer's investigation of the incident.
Amendment 656 #
Proposal for a regulation
Article 63 – paragraph 3 – subparagraph 1
Article 63 – paragraph 3 – subparagraph 1
In the case of devices referred to in the first subparagraph of Article 1(4) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for medicinal products, or the European Medicines Agency (EMA), that was consulted by the notified body in accordance with the second subparagraph of Article 42(2).
Amendment 657 #
Proposal for a regulation
Article 63 – paragraph 3 – subparagraph 2
Article 63 – paragraph 3 – subparagraph 2
In the case of devices covered by this Regulation in accordance with point (e) of Article 1(2) and where the serious incident or field safety corrective action may be related to the tissues or cells of human origin utilised for the manufacture of the device, the competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for human tissues and cells that was consulted by the notified body in accordance with the third subparagraph of Article 42(2).
Amendment 658 #
Proposal for a regulation
Article 63 – paragraph 4
Article 63 – paragraph 4
4. After carrying out the assessment, the evaluating competent authority shall, through the electronic system referred to in Article 62, inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or imposed on him to minimise the risk of recurrence of a serious incident, including information on the underlying events and the outcome of its assessment.
Amendment 659 #
Proposal for a regulation
Article 63 – paragraph 6 – subparagraph 1 – point a
Article 63 – paragraph 6 – subparagraph 1 – point a
(a) where similar serious incidents related to the same device or type of device of the same manufacturer occur in more than one Member State;
Amendment 660 #
Proposal for a regulation
Article 63 – paragraph 7 – subparagraph 1 – point a
Article 63 – paragraph 7 – subparagraph 1 – point a
(a) to monitor the investigation of the serious incident by the manufacturer and the corrective action to be taken;
Amendment 661 #
Proposal for a regulation
Article 63 – paragraph 7 – subparagraph 1 – point b
Article 63 – paragraph 7 – subparagraph 1 – point b
(b) to consult with the notified body that issued a certificate in accordance with Article 45 for the device in question regarding the impact of the serious incident on the certificate;
Amendment 662 #
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
Manufacturers of devices classified in class IIb and III shall report to the electronic system referred to in Article 62 any statistically significant increase in the frequency or severity of incidents that are not seriousall incidents or of expected undesirable side-effects that have a significant impact on the risk-benefit analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons when weighted against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents or expected undesirable side-effects in respect of the device, or category or group of devices, in question during a specific time period as established in the manufacturer's conformity assessment. Article 63 shall apply.
Amendment 664 #
Proposal for a regulation
Article 66 – paragraph 1 – point a
Article 66 – paragraph 1 – point a
(a) typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices;
Amendment 665 #
Proposal for a regulation
Article 66 – paragraph 1 – point b
Article 66 – paragraph 1 – point b
(b) harmonised forms for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers as referred to in Articles 61 and 64;
Amendment 666 #
Proposal for a regulation
Article 66 – paragraph 1 – point c
Article 66 – paragraph 1 – point c
(c) timelines for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers, taking into account the severity of the event to be reported as referred to in Articles 61 and 64;
Amendment 667 #
Proposal for a regulation
Article 66 – paragraph 2 – subparagraph 1 (new)
Article 66 – paragraph 2 – subparagraph 1 (new)
In drafting the implementing acts, the Commission shall seek the prior advice of the MDAG
Amendment 671 #
Proposal for a regulation
Article 67 – paragraph 1
Article 67 – paragraph 1
1. The competent authorities shall perform appropriate checks on the characteristics and performance of devices including, where appropriate, review of documentation and physical or laboratory checks on the basis of adequate samples. They shall take account of established principles regarding risk assessment and risk management, vigilance data and complaints. The competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and, where necessary and justified, enter the premises of economic operators and take the necessary samples of devices. They may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary.
Amendment 681 #
Proposal for a regulation
Article 68 – paragraph 2 – subparagraph 1 (new)
Article 68 – paragraph 2 – subparagraph 1 (new)
The information in to relation to Article 68 paragraph 1, points a, b, c and d shall be made available to the MDCG who shall communicate it at the first meeting of the MDAG after the information becomes available.
Amendment 683 #
Proposal for a regulation
Article 69 – paragraph 1 – point 1 (new)
Article 69 – paragraph 1 – point 1 (new)
(1) Where the competent authorities of a Member State, based on vigilance data or other information, have reason to believe that a device presents a risk to the health or safety of patients, users or other persons, they may carry out an evaluation in relation to the device concerned covering all the requirements laid down in this Regulation that are relevant to the risk presented by the device. The relevant economic operators shall cooperate as necessary with the competent authorities.
Amendment 684 #
Proposal for a regulation
Article 70 – paragraph 1
Article 70 – paragraph 1
1. Where, having performed an evaluation pursuant to Article 69, the competent authorities find that the device, which presents a risk to the health or safety of patients, users or other persons, does not comply with the requirements laid down in this Regulation, they shall without dimmediatelay require the relevant economic operator to take all appropriate and duly justified corrective action to bring the device into compliance with those requirements, to prohibit or restrict the making available of the device on the market, to subject the making available of the device to specific requirements, to withdraw the device from the market, or to recall it within a reasonable period that is clearly defined and communicated to the relevant economic operator, proportionate to the nature of the risk.
Amendment 685 #
Proposal for a regulation
Article 70 – paragraph 2
Article 70 – paragraph 2
2. Where the competent authorities consider that non-compliance is not restricted to their national territory, they shall immediately inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operators to take, by means of the electronic system referred to in Article 68.
Amendment 686 #
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. The economic operators shall without delay ensure that all appropriate corrective action is taken in respect of all the devices concerned that they have made available on the market throughout the Union.
Amendment 687 #
Proposal for a regulation
Article 70 – paragraph 3 – point 1 (new)
Article 70 – paragraph 3 – point 1 (new)
(1) Where the concerned devices are to be recalled, the economic operator shall make all reasonable efforts to complete the recall before the end of clearly defined period communicated to it by the competent authority as referred to in paragraph 1,
Amendment 688 #
Proposal for a regulation
Article 70 – paragraph 4 – subparagraph 2
Article 70 – paragraph 4 – subparagraph 2
They shall notify the Commission and the other Member States, without dimmediatelay, of those measures, by means of the electronic system referred to in Article 68.
Amendment 689 #
Proposal for a regulation
Article 70 – paragraph 6
Article 70 – paragraph 6
6. Member States other than the Member State initiating the procedure shall without delay inform the Commission and the other Member States of any additional information at their disposal relating to the non-compliance of the device concerned and of any measures adopted by them in relation to the device concerned. In the event of disagreement with the notified national measure, they shall without dimmediatelay inform the Commission and the other Member States of their objections, by means of the electronic system referred to in Article 68.
Amendment 690 #
Proposal for a regulation
Article 70 – paragraph 7
Article 70 – paragraph 7
7. Where, within twoone months of receipt of the notification referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
Amendment 691 #
Proposal for a regulation
Article 70 – paragraph 8
Article 70 – paragraph 8
8. All Member States shall ensure that appropriate restrictive measures are taken without dimmediatelay in respect of the device concerned.
Amendment 692 #
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
1. Where, within twoone months of receipt of the notification referred to in Article 70(4), objections are raised by a Member State against a provisional measure taken by another Member State, or where the Commission considers the measure to be contrary to Union legislation, the Commission shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide, by means of implementing acts, whether or not the national measure is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 693 #
Proposal for a regulation
Article 72 – paragraph 1
Article 72 – paragraph 1
1. Where, having performed an evaluation pursuant to Article 69, a Member State finds that although a device has been legally placed on the market or put into service, it presents a risk to the health or safety of patients, users or other persons or to other aspects of the protection of public health, it shall immediately require the relevant economic operator or operators to take all appropriate provisional measures to ensure that the device concerned, when placed on the market or put into service, no longer presents that risk, to withdraw the device from the market or to recall it within a reasonable period, proportionate to the nature of the risk.
Amendment 694 #
Proposal for a regulation
Article 73 – paragraph 1 – introductory part
Article 73 – paragraph 1 – introductory part
1. Without prejudice to Article 70, a Member State shall require the relevant economic operator to put an end to the non-compliance concerned within a reasonable period that is clearly defined and communicated and that is proportionate to the non-compliance where it makes one of the following findings:
Amendment 695 #
Proposal for a regulation
Article 73 – paragraph 2
Article 73 – paragraph 2
2. Where the economic operator does not put an end to the non-compliance within the period referred to in paragraph 1, the Member State concerned shall immediately take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market. That Member State shall inform the Commission and the other Member States without dimmediatelay of those measures, by means of the electronic system referred to in Article 68.
Amendment 698 #
Proposal for a regulation
Article 75 – paragraph 2
Article 75 – paragraph 2
2. Except in cases where immediate action is necessary for reasons of serious risk to human health or safety, the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time that is clearly defined before any measure is adopted. If action has been taken without the economic operator being heard, he shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter.
Amendment 699 #
Proposal for a regulation
Article 75 – paragraph 3
Article 75 – paragraph 3
3. Any measure adopted shall be immediately withdrawn or amended upon the economic operator's satisfactorily demonstrating that he has taken effective corrective action.
Amendment 700 #
Proposal for a regulation
Article 76 – paragraph 1
Article 76 – paragraph 1
1. The Member States shall designate the competent authority or authorities responsible for the implementation of this Regulation. They shall entrust their authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. The Member States shall communicate the competent authorities to the Commission which shall publish a list of competent authorities and their contact details.
Amendment 701 #
Proposal for a regulation
Article 77 – paragraph 1
Article 77 – paragraph 1
1. The competent authorities of the Member States shall cooperate with each other and with the Commission and with the MDCG as appropriate and exchange with each other and the Commission the information necessary to enable this Regulation to be applied uniformly.
Amendment 702 #
Proposal for a regulation
Article 78 a (new)
Article 78 a (new)
Amendment 703 #
Proposal for a regulation
Article 78 – paragraph 2 – subparagraph 1
Article 78 – paragraph 2 – subparagraph 1
Each Member State shall appoint, for a three-year term which may be renewed, one member and one or more alternate providing expertise in the field of this Regulation, and one member and one or more alternate providing expertise in the field of Regulation (EU) No […/…] [on in vitro diagnostic medical devices]. A Member State may choose to appoint only one member and one or more alternates providing expertise in both fields.
Amendment 704 #
Proposal for a regulation
Article 78 – paragraph 2 – subparagraph 2 a (new)
Article 78 – paragraph 2 – subparagraph 2 a (new)
The Commission shall verify the competence of the members of the MDCG. The Commission shall make public the results of its verification in each instance and provide information about the competence of the members of the MDCG.
Amendment 707 #
Proposal for a regulation
Article 78 – paragraph 7
Article 78 – paragraph 7
7. The MDCG mayshall establish a standing orMedical Device Advisory Group and may establish temporary sub-groups. W where appropriate, o. Organisations representing the interests of the medical device industrypatients, healthcare professionals, laboratories, patients and consumersconsumers and the medical device industry at Union level shall be invited in such sub-groups in the capacity of observers. Members of the MDAG may be invited in such sub-groups in the capacity of advisors where appropriate.
Amendment 711 #
Proposal for a regulation
Article 78 – paragraph 8 – subparagraph 1 – indent 3 a (new)
Article 78 – paragraph 8 – subparagraph 1 – indent 3 a (new)
- The functioning of the MDAG, including the adoption of opinions or recommendations or other positions by the MDAG where appropriate.
Amendment 712 #
Proposal for a regulation
Article 80 – paragraph 1 – point a a (new)
Article 80 – paragraph 1 – point a a (new)
(a a) to jointly assess with the Commission and the national authority responsible for notified bodies of the Member State in which it is established an application by a conformity assessment body for notification in all cases where the applicant body claims to be competent in devices listed in class III, those implanted into the body, incorporating a substance considered to be a medicinal product, or utilising non-viable tissues or cells of human or animal origin, or their derivatives.
Amendment 713 #
Proposal for a regulation
Article 80 – paragraph 1 – point a b (new)
Article 80 – paragraph 1 – point a b (new)
(a b) to establish and document the high level principles of competence and qualification and procedures for selection and authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required training (initial and ongoing). The qualification criteria shall address the various functions within the conformity assessment process as well as the devices, technologies and areas covered by the scope of designation.
Amendment 714 #
Proposal for a regulation
Article 80 – paragraph 1 – point a c (new)
Article 80 – paragraph 1 – point a c (new)
(a c) to review and approve the criteria of the competent authorities of Member States in respect of article 80 - paragraph 1 - point a b - above
Amendment 715 #
Proposal for a regulation
Article 80 – paragraph 1 a (new)
Article 80 – paragraph 1 a (new)
1a) The MDCG shall create and maintain a list of appropriately qualified and recognised clinical experts and their clinical specialty which shall be made available to the conformity assessment bodies notified for class III devices, those implanted into the body, incorporating a substance considered to be a medicinal product, or utilising non-viable tissues or cells of human or animal origin, or their derivatives for the purposes of complying with the notification requirement in Article 44
Amendment 716 #
Proposal for a regulation
Article 80 – paragraph 1 b (new)
Article 80 – paragraph 1 b (new)
1b) The MDCG shall hear the MDAG. The MDCG shall note the adoption of opinions or recommendations or other positions by the MDAG and may adopt them itself where appropriate.
Amendment 741 #
Proposal for a regulation
Article 82 – paragraph 1
Article 82 – paragraph 1
1. Members of the MDCG and staff of the EU reference laboratories shall not have financial or other interests in the medical device industry or in the supply chain which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner. They shall declare any direct and indirect interests they may have in the medical device industry or in the supply chain and update this declaration whenever a relevant change occurs. Upon request, the declaration of interests shall be accessible to the public. This Article shall not apply to the representatives of stakeholder organisations participating in the sub- groups of the MDCG.
Amendment 749 #
Proposal for a regulation
Article 86 – paragraph 1
Article 86 – 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 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. The structure and level of fees shall be publicly available on request.
Amendment 752 #
Proposal for a regulation
Article 89 – paragraph 1 – subparagraph 1 (new)
Article 89 – paragraph 1 – subparagraph 1 (new)
The Commission shall, in drafting delegated acts, seek the advice of the MDCG.
Amendment 759 #
Proposal for a regulation
Annex 1 – part I – point 2 – point c
Annex 1 – part I – point 2 – point c
(c) reduce as far as possible the remaining risks by taking adequate protection measures, including alarms; hence, it should take into consideration the latest tools and concepts developed in hazard and risk assessment based on human- relevant models, pathways of toxicity, adverse outcome pathways and evidence- based toxicology; and
Amendment 760 #
Proposal for a regulation
Annex 1 – part I – point 2 – point d a (new)
Annex 1 – part I – point 2 – point d a (new)
(d a) Points a, b, c and d, above, shall not reduce the necessity for clinical investigation and post-market clinical follow up to adequately address the risks, hazards and performance of devices.
Amendment 773 #
Proposal for a regulation
Annex 1 – part II – point 9 – point 9.2
Annex 1 – part II – point 9 – point 9.2
Amendment 818 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.1
Annex 6 – point 3 – point 3.2 – point 3.2.1
3.2.1. The Notified BodyMDCG shall establish and document the principals of high level competence and qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required training (initial and ongoing training). The qualification criteria shall address the various functions within the conformity assessment process (e.g. auditing, product evaluation/testing, design dossier/file review, decision-making) as well as the devices, technologies and areas (e.g. biocompatibility, sterilisation, tissues and cells of human and animal origin, clinical evaluation) covered by the scope of designation.
Amendment 823 #
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)
- Ensure independence and objectivity and disclose potential conflicts of interest.
Amendment 836 #
Proposal for a regulation
Annex 6 – point 4 – point 4.1
Annex 6 – point 4 – point 4.1
4.1. The notified body's decision-making process shall be clearly documented and publicly available, including the process for the issue, suspension, reinstatement, withdrawal or refusal of conformity assessment certificates, their modification or restriction and the issue of supplements.
Amendment 838 #
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 851 #
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
All devices incorporating or consisting of nanomaterial are in class III unless the nanomaterial is encapsulated or bound in such a manner that it cannot beintended to be intentionally released into the patient's or user's body when the device is used within its intended purposehuman body are classified as class III.
Amendment 855 #
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.8 – paragraph 1
Annex 7 – part III – point 6 – point 6.8 – paragraph 1
Amendment 860 #
Proposal for a regulation
Annex 8 – point 3 – point 3.2 – paragraph 1 – point d – indent 2
Annex 8 – point 3 – point 3.2 – paragraph 1 – point d – indent 2
– the product identification and traceability procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;
Amendment 863 #
Proposal for a regulation
Annex 8 – point 4 – point 4.1
Annex 8 – point 4 – point 4.1
4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils all the obligations imposed by the approved quality management system.
Amendment 869 #
Proposal for a regulation
Annex 8 – point 4 – point 4.4 – introductory part
Annex 8 – point 4 – point 4.4 – introductory part
4.4. The notified body shall randomly perform unannounced factory inspections to the manufacturer and, if appropriate, of the manufacturer'ts suppliers and/or subcontractors, which may be combined with in addition to the periodic surveillance assessment referred to in Section 4.3. or be performed in addition to this surveillance assessment. The notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturer. The notified body shall carry out at least one unannounced inspection every three years.
Amendment 875 #
Proposal for a regulation
Annex 8 – point 5 – point 5.3 a (new)
Annex 8 – point 5 – point 5.3 a (new)
5.3 a. 5.3bis For devices in class III the clinical part of the dossier shall be evaluated by an appropriate clinical expert among those contained in the list developed by the MDCG according to Art. 80 g)