Activities of António Fernando CORREIA DE CAMPOS related to 2012/0267(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
Amendments (42)
Amendment 51 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 3
Article 2 – paragraph 1 – subparagraph 1 – point 3
(3) ‘'accessory to an in vitro diagnostic medical device’' means an article which, whilst not being an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable or assist the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically assist the medical functionality of the in vitro diagnostic medical device(s) in view of its/their intended purpose(s);
Amendment 54 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 28
Article 2 – paragraph 1 – subparagraph 1 – point 28
(28) ‘'clinical evidence’' means the information that supportsdata, positive and negative, supporting the evaluation of the scientific validity and performance for the use of a device as intended by the manufacturer;
Amendment 55 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 30
Article 2 – paragraph 1 – subparagraph 1 – point 30
(30) ‘'performance of a device’' means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analyticalattainment of technical capabilities, analytical performance and, where applicable, the clinical performance supporting the intended purpose of the device;
Amendment 56 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 35
Article 2 – paragraph 1 – subparagraph 1 – point 35
(35) ‘'performance evaluation’' means the assessment and analysis of data to establish or verify theat the device performs as intended by the manufacturer, including the technical, analytical and, where applicable, the clinical performance of a device;
Amendment 59 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 1
Article 4 – paragraph 5 – subparagraph 1
With the exception of Article 59(4), the requirements of this Regulation shall not apply to devices classified as class A, B and C, in accordance with the rules set out in Annex VII, and manufactured and used only within a single health institution, provided manufacture and use occur solely under the health institution's single quality management system, and the health institution is compliantaccredited with standard EN ISO 15189 or any other equivalent recognised standard. Member States may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 61 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2 a (new)
Article 4 – paragraph 5 – subparagraph 2 a (new)
By way of derogation from the first subparagraph, devices classified as class D and required to be used for transfusion or transplantation purposes, may be manufactured and used within a single health institution without fulfilling the full requirements of this Regulation, provided that they comply with the conditions defined in the first subparagraph, essential requirements in Annex I, applicable harmonized standards referred to in Article 6 and applicable common technical specifications referred to in Article 7. This derogation is applicable only if, and for as long as such devices are not available on the market as CE marked.
Amendment 63 #
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 1
Article 8 – paragraph 6 – subparagraph 1
Proportionate to the risk class and the type of device, manufacturers of devices shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service, and to apply any necessary corrective action, hereinafter referred to as ‘'post-market surveillance plan’'. The post-market surveillance plan shall set out the process for collecting, recording, communicating to the electronic system on vigilance referred in Article 60 and investigating complaints and reports from healthcare professionals, patients or users on suspected incidents related to a device, keeping a register of non-conforming products and product recalls or withdrawals, and if deemed appropriate due to the nature of the device, sample testing of marketed devices. Part of the post-market surveillance plan shall be a plan for post-market follow-up in accordance with Part B of Annex XII. Where post-market follow-up is not deemed necessary, this shall be duly justified and documented in the post- market surveillance plan and subject to approval by the competent authority.
Amendment 71 #
Proposal for a regulation
Article 22 – paragraph 8 – point b
Article 22 – paragraph 8 – point b
(b) the legitimate interest in protecting commercially sensitive information, to the extent that it does not undermine public health protection;
Amendment 75 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. In the case of devices classified as class C and D, other than devices for performance evaluation, the manufacturer shall draw up a summary of safety and performance. It shall be written in a way that is clear to the intended user. This summary shall be accompanied by the dataset collected during the clinical investigation and the post-market clinical follow-up. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 40 and shall be validated by that body.
Amendment 76 #
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 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. Based on this exchange of information and on best practices established across Member States, the Commission shall define, within 2 years of the entry into force of this Regulation, guidelines for the procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies to be carried out by national authorities concerned.
Amendment 77 #
Proposal for a regulation
Article 28 – paragraph 1 a (new)
Article 28 – paragraph 1 a (new)
1a. Subcontracting shall be limited to only specific tasks connected with the conformity assessment and the need to subcontract such tasks shall be duly justified to the national authority.
Amendment 78 #
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
1a. Any subsidiaries of the applicant conformity assessment body which are involved in the conformity assessment process, in particular those located in third countries, shall be subject to the application for notification mechanism and its assessment as described in Article 30.
Amendment 79 #
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. The Commission shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body of the requirements set out in Annex VI or the obligations to which it is subject. It may also commence such investigations on its own initiative, including the unannounced inspection of the notified body by a joint assessment team whose composition meets the conditions set out in Article 30(3).
Amendment 80 #
Proposal for a regulation
Article 40 – paragraph 9 – subparagraph 1 – introductory part
Article 40 – paragraph 9 – 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 81 #
Proposal for a regulation
Article 47 – paragraph 4
Article 47 – paragraph 4
4. Where demonstration of conformity with the general safety and performance requirements based on clinical performance data or parts thereof is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the characteristics of the device and, in particular, its intended purpose(s), the intended performance and the claims of the manufacturer. The adequacy of demonstration of conformity with the general safety and performance requirements based on the results of analytical performance evaluation alone shall be duly substantiated in the technical documentation referred to in Annex II. Exemption from demonstration of conformity with general safety and performance requirements based on clinical data under the first subparagraph shall be subject to prior approval by the competent authority.
Amendment 82 #
Proposal for a regulation
Article 47 – paragraph 5
Article 47 – paragraph 5
5. The scientific validity data, the analytical performance data and, where applicable, the clinical performance data shall be summarised as part of a clinical evidence report referred to in Section 3 of Part A of Annex XII. The clinical evidence report shall be included or fully referenced in the technical documentation referred to in Annex II relating to the device concerned. and be made accessible to the public through the electronic system referred to in Article 51 at the time the device is placed on the market.
Amendment 83 #
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 and that the clinical data generated in the clinical performance study are going to be reliable and robust. Realization of the clinical performance studies shall be subject to a positive opinion by the responsible Ethics Committee.
Amendment 84 #
Proposal for a regulation
Article 49 – paragraph 6 – subparagraph 2
Article 49 – 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 patient shall be taken into account. Realization of the clinical performance studies shall be subject to a positive opinion by the responsible Ethics Committee.
Amendment 85 #
Proposal for a regulation
Article 51 – paragraph 1 – point a
Article 51 – paragraph 1 – point a
(a) the registration of clinical performance studies in accordance with Article 50 and the clinical data generated;
Amendment 86 #
Proposal for a regulation
Article 51 – paragraph 1 – point c
Article 51 – paragraph 1 – point c
(c) the information related to clinical performance studies conducted in more than one Member State and the clinical data generated in case of a single application in accordance with Article 56;
Amendment 87 #
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 and in Article 51 (a), (c) and (d), the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission.
Amendment 88 #
Proposal for a regulation
Article 51 – paragraph 3
Article 51 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 for determining which other information regarding clinical performance studies collated and processed in the electronic system shall be publicly accessiblethe technical requirements and parameters to allow interoperability with the EU database for clinical trials on medicinal products for human use set up by Regulation (EU) No [Ref. of future Regulation on clinical trials]. Article 50(3) and (4) shall apply.
Amendment 89 #
Proposal for a regulation
Article 53 – paragraph 1
Article 53 – paragraph 1
1. If the sponsor introduces modifications to a clinical performance study that are likely to have a substantial impact on the safety or rights of the subjects or on the robustness or reliability of the clinical data generated by the study, he shall notify the Member State(s) and the Ethics Committee concerned of the reasons for and the content of those modifications. The notification shall be accompanied by an updated version of the relevant documentation referred to in Annex XIII.
Amendment 90 #
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 30 days after notification, unless the Member State concerned has notified the sponsor of its refusal based on considerations of public health, patient safety or public policyduly justified refusal.
Amendment 91 #
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 grounds, that Member State shall communicate such facts and its decision and the grounds therefore to all Member States and the Commission by means of the electronic system referred to in Article 51.
Amendment 92 #
Proposal for a regulation
Article 55 – paragraph 3
Article 55 – paragraph 3
3. Within one year from the end of the clinical performance study, the sponsor shall submit to the Member States concerned a summary of the results of the clinical performance study in form of a clinical performance study report referred to in Section 2.3.3 of Part A of Annex XII. together with all the data collected during the clinical performance study, including negative findings. Where, for scientific reasons, it is not possible to submit the clinical performance study report within one year, it shall be submitted as soon as it is available. In this case, the clinical performance study protocol referred to in Section 2.3.2 of Part A of Annex XII shall specify when the results of the clinical performance study are going to be submitted, together with an explanation.
Amendment 93 #
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. If that Member State does not wish to be the coordinating Member State, itConcerned Member States shall agree, within six days of submission of the single application, with anotherhich 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 becoms and the Commission shall agree, in the framework of the attributions of the Medical Devices cCoordinating Member State, the deadlines referred to in Article 49(2) shall start on the day following the acceptancon Group, on clear rules for designating the coordinating Member State.
Amendment 94 #
Proposal for a regulation
Article 57 – paragraph 1 – introductory part
Article 57 – paragraph 1 – introductory part
1. The sponsor shall fully record and register in the electronic system on clinical investigations referred to in Article 51, any of the following:
Amendment 96 #
Proposal for a regulation
Article 57 – paragraph 4 – subparagraph 1
Article 57 – paragraph 4 – subparagraph 1
In the case of a clinical performance studyinvestigation for which the sponsor has used the single application referred to in Article 56, the sponsor shall report any event as referred to in paragraphs 1 and 2 by means of the electronic system referred to in Article 51. Upon receipt, this report shall be transmitted electronically to all Member States concerned.
Amendment 98 #
Proposal for a regulation
Article 59 – paragraph 3 a (new)
Article 59 – paragraph 3 a (new)
3a. Member States and the Commission shall develop and guarantee the interoperability between national records and the electronic system on vigilance referred to in Article 60, to ensure the automated export of data to this system, while avoiding duplication of registries.
Amendment 100 #
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 notified bodies, to the notified bodies and without prejudice to the preservation of intellectual property, to healthcare professionals and the public. The data referred to in points (a) to (e) of Article 60(1) shall not be considered commercially confidential information.
Amendment 101 #
Proposal for a regulation
Article 60 – paragraph 3
Article 60 – paragraph 3
Amendment 103 #
Proposal for a regulation
Article 90 – paragraph 2
Article 90 – paragraph 2
2. It shall apply from [fivthree years after entry into force].
Amendment 104 #
Proposal for a regulation
Annex 5 – section 1 – paragraph 1 – point 15
Annex 5 – section 1 – paragraph 1 – point 15
15. in case of devices classified as class C or D, the summary of safety and performance, and the full dataset collected during the clinical study and the post- market clinical follow-up.
Amendment 105 #
Proposal for a regulation
Annex 8 – section 1 – point 4 – point 4.4 – introductory part
Annex 8 – section 1 – 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's suppliers and/or subcontractors, which may be combined with 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 shall not take a periodicity lower than one inspection per year and shall not be disclosed to the manufacturer.
Amendment 107 #
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.1 – point 1.2.1.4
Annex 12 – section 1 – point 1 – point 1.2.1 – point 1.2.1.4
1.2.1.4 The analytical performance full dataset shall be summarised as part ofaccompany the clinical evidence report and may be summarised as part of it.
Amendment 108 #
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.5
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.5
1.2.2.5 Clinical performance full dataset shall be summarised as part ofaccompany the clinical evidence report and may be summarised as part of it.
Amendment 109 #
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 2
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 2
– For devices classified as class C according to the rules set out in Annex VII, the clinical performance study report shall include the method of data analysis, the study conclusion and the relevant details of the study protocol and the full dataset;
Amendment 110 #
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 3
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 3
– For devices classified as class D according to the rules set out in Annex VII, the clinical performance study report shall include the method of data analysis, the study conclusion, the relevant details of the study protocol and the individual data pointsfull dataset.
Amendment 111 #
Proposal for a regulation
Annex 12 – section 1 – point 2 – point 2.2 – paragraph 1
Annex 12 – section 1 – point 2 – point 2.2 – paragraph 1
Every step in the clinical performance study, from first consideration of the need and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, as for example those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964 and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, in 2008. Conformity with the above principles shall be granted through a favourable opinion of the concerned Ethics Committee.
Amendment 112 #
Proposal for a regulation
Annex 12 – section 1 – point 2 – point 2.3 – point 2.3.3 – paragraph 1
Annex 12 – section 1 – point 2 – point 2.3 – point 2.3.3 – paragraph 1
A ‘'clinical performance study report’', signed by a medical practitioner or any other authorised person responsible, shall contain documented information on the clinical performance study protocol, results and conclusions of the clinical performance study, including negative findings. The results and conclusions shall be transparent, free of bias and clinically relevant. The report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents. The report shall also include as appropriate any protocol amendments or deviations, and data exclusions with the appropriate rationale. The report shall be accompanied by the clinical evidence report as described in point 3.1 and be accessible to the public with the placing on the market of the device through the electronic system referred to in Article 51.
Amendment 113 #
Proposal for a regulation
Annex 12 – section 1 – point 3 – point 3.3
Annex 12 – section 1 – point 3 – point 3.3
3.3 The clinical evidence data and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer's post-market surveillance plan referred to in Article 8(5) which shall include a plan for the device post-market follow-up in accordance with Part B of this Annex. The clinical evidence data and its subsequent updates through post-market follow-up shall be accessible to the public through the electronic systems referred to in Art. 51 and Art. 60.