Activities of António Fernando CORREIA DE CAMPOS related to 2012/0266(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
Amendments (40)
Amendment 97 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
The implantable or other invasive products, intended to be used for human beings, which are listed on a non-exhaustive basis in Annex XV, shall be considered medical devices for the purposes of this Regulation, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose.
Amendment 103 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 36 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 36 – introductory part
(36) ‘clinical data’ means all the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:
Amendment 104 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 36 – indent 3
Article 2 – paragraph 1 – subparagraph 1 – point 36 – indent 3
– published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
Amendment 105 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 36 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 36 a (new)
(36a) ‘performance’ means the ability of a device to produce the effect intended by the manufacturer relative to the medical condition, including attainment of technical capabilities and clinical claims;
Amendment 114 #
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, other than custom-made 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 to in Article 62 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 clinical follow-up in accordance with Part B of Annex XIII. Where post-market clinical 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. Second subparagraph shall not apply to class III medical devices.
Amendment 119 #
Proposal for a regulation
Article 15 – paragraph 4 a (new)
Article 15 – paragraph 4 a (new)
Amendment 137 #
Proposal for a regulation
Article 24 – paragraph 8 – point b
Article 24 – paragraph 8 – point b
(b) the legitimate interest in protecting commercially sensitive information, providing that it does not conflict with public health protection;
Amendment 142 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical 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 42 and shall be validated by that body.
Amendment 143 #
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. Based on this exchange of information and on best practices established across Member States, the Commission shall define, within 2 years after 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 145 #
Proposal for a regulation
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
1 a. 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 146 #
Proposal for a regulation
Article 31 – paragraph 1 b (new)
Article 31 – paragraph 1 b (new)
1b. 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 32.
Amendment 151 #
Proposal for a regulation
Article 37 – paragraph 1
Article 37 – 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 32(3).
Amendment 155 #
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 162 #
Proposal for a regulation
Article 49 – paragraph 3
Article 49 – paragraph 3
3. WExcept for class III devices, where demonstration of conformity with general safety and performance requirements based on clinical data 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 specifics of the interaction between the device and the human body, the clinical performances intended and the claims of the manufacturer. The adequacy of demonstration of conformity with the general safety and performance requirements based on the results of non- clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, has to 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 163 #
Proposal for a regulation
Article 49 – paragraph 5
Article 49 – paragraph 5
5. The clinical evaluation and its outcome shall be documented in a clinical evaluation report referred to in Section 6 of Part A of Annex XIII which 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 53 at the time the device is placed on the market.
Amendment 165 #
Proposal for a regulation
Article 50 – paragraph 1 – introductory part
Article 50 – paragraph 1 – introductory part
1. Clinical investigations whether they are carried out with the purpose of placing on the market of a medical device or its post- marketing study shall be subject to Articles 50-60 and Annex XIV if they are conducted for one or more of the following purposes:
Amendment 166 #
Proposal for a regulation
Article 51 – paragraph 6 – subparagraph 1
Article 51 – paragraph 6 – subparagraph 1
Member States shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor, the institution of the investigation site(s) and the investigators involved, as well as free of any other undue influence. 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 investigation shall be subject to a positive opinion by the responsible Ethics Committee.
Amendment 167 #
Proposal for a regulation
Article 52 – paragraph 3 – point b
Article 52 – paragraph 3 – point b
(b) protection of commercially sensitive information; data on adverse events and safety data shall not be considered commercially sensitive information;
Amendment 168 #
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – 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 […/….../...]. With the exception of the information referred to in Article 52, and point (d) of Article 53(1) the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission.
Amendment 169 #
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 for determining which other information regarding clinical investigations 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 […/…]. Article 52(3) and (4) shall apply.../...].
Amendment 170 #
Proposal for a regulation
Article 55 – paragraph 2
Article 55 – 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 171 #
Proposal for a regulation
Article 55 – paragraph 2 a (new)
Article 55 – paragraph 2 a (new)
2a. Assessment by the Member State of the request by the sponsor for a substantial modification to a clinical investigation shall be in accordance with Article 51(6).
Amendment 172 #
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
1. Where a Member State has refused, suspended or terminated a clinical investigation, or has called for a substantial modification or temporary halt of a clinical investigation, or has been notified by the sponsor of the early termination of a clinical investigation on safety grounds, that Member State shall communicate such facts and its decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 53.
Amendment 173 #
Proposal for a regulation
Article 57 – paragraph 2 – subparagraph 2
Article 57 – paragraph 2 – subparagraph 2
If the investigation is conducted in more than one Member State the sponsor shall notify all Member States concerned of the early termination in one Member State and of the overall end of the clinical investigation. That notification shall be made within 15 days from the overall end of the clinical investigation in one or more Member States.
Amendment 174 #
Proposal for a regulation
Article 57 – paragraph 3
Article 57 – paragraph 3
3. Within one year from the end of the clinical investigation, the sponsor shall submit to the Member States concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in Section 2.7 of Chapter I of Annex XIV, together with all the data collected during the clinical investigation, including negative findings. Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year, it shall be submitted as soon as it is available. In this case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XIV shall specify when the results of the clinical investigation are going to be submitted, together with an explanation.
Amendment 175 #
Proposal for a regulation
Article 58 – paragraph 2
Article 58 – 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 becomes coordinating Member State, the deadline referred to in Article 51(2) shall start on the day following the acceptancMember States and the Commission shall agree, in the framework of the attributions of the MDCG, on clear rules for designating the coordinating Member State.
Amendment 176 #
Proposal for a regulation
Article 59 – paragraph 1 – introductory part
Article 59 – paragraph 1 – introductory part
1. The sponsor shall fully record and register in the electronic system on clinical investigations referred to in Article 53, any of the following:
Amendment 177 #
Proposal for a regulation
Article 59 – paragraph 4 – subparagraph 1
Article 59 – paragraph 4 – subparagraph 1
In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 58, the sponsor shall report any event as referred to in paragraphs 1 and 2 by means of the electronic system referred to in Article 53. Upon receipt, this report shall be transmitted electronically to all Member States concerned.
Amendment 179 #
Proposal for a regulation
Article 61 – paragraph 3 a (new)
Article 61 – 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 62, to ensure the automated export of data to this system, while avoiding duplication of registries.
Amendment 181 #
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – 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 62(1) shall not be considered commercially confidential information.
Amendment 182 #
Proposal for a regulation
Article 62 – paragraph 3
Article 62 – paragraph 3
Amendment 185 #
Proposal for a regulation
Article 78 – paragraph 6 a (new)
Article 78 – paragraph 6 a (new)
6a. The MDCG may establish standing or temporary panels of experts in specific areas of medicine, or in relevant technical areas, with a view to implementing this Regulation and providing scientific advice to the MDCG.
Amendment 186 #
Proposal for a regulation
Article 82 – paragraph 1
Article 82 – paragraph 1
1. Members of the MDCG, of the advisory panels to the MDCG and staff of the EU reference laboratories shall not have financial or other interests in the medical device industry 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 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 organiszations participating in the sub- groups of the MDCG.
Amendment 195 #
Proposal for a regulation
Annex 5 – section 1 – paragraph 1 – point 18
Annex 5 – section 1 – paragraph 1 – point 18
18. in case of devices classified as class III or implantable devices, the summary of safety and clinical performance, accompanied by the full dataset collected during the clinical investigation and the post-market clinical follow-up.
Amendment 205 #
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’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 must not be disclosed to the manufacturer.
Amendment 207 #
Proposal for a regulation
Annex 13 – part B – point 1
Annex 13 – part B – point 1
1. Post-market clinical follow-up, hereinafter: PMCF, is a continuous process to update the clinical evaluation referred to in Article 49 and Part A of this Annex and shall be part of the manufacturer’s post- market surveillance plan. To this end, the manufacturer shall proactively collect, register in the electronic system on vigilance referred to in Article 62 and evaluate clinical data from the use in or on humans of a device which is authorised to bear the CE marking, within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence.
Amendment 208 #
Proposal for a regulation
Annex 13 – part B – point 3
Annex 13 – part B – point 3
3. The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the technical documentation and be sent periodically to the concerned Member States.
Amendment 209 #
Proposal for a regulation
Annex 13 – part B – point 4
Annex 13 – part B – point 4
4. The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 49 and Part A of this Annex and in the risk management referred to in Section 2 of Annex I. If through the PMCF the need for corrective measures has been identified, the manufacturer shall implement them and inform the concerned Member States.
Amendment 210 #
Proposal for a regulation
Annex 14 – part I – point 1 – paragraph 1
Annex 14 – part I – point 1 – paragraph 1
Every step in the clinical investigation, 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 Association General Assembly in Helsinki, Finland, in 1964, and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, in 2008. Accordance with these principles shall be guaranteed by means of a favourable opinion from an ethics committee.
Amendment 211 #
Proposal for a regulation
Annex 14 – part I – point 2 – point 2.7
Annex 14 – part I – point 2 – point 2.7
2.7. The clinical investigation report, signed by the medical practitioner or other authorised person responsible, shall contain a critical evaluation of all thell clinical data collected during the clinical investigation, including negative findings and a critical evaluation of such data, including negative findings and must be publicly accessible through the electronic system referred to in Article 53.