40 Amendments of Corinne LEPAGE related to 2012/0266(COD)
Amendment 147 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) The desire to provide swift access to new medical devices for patients should never take precedence over the need to ensure patient safety.
Amendment 149 #
Proposal for a regulation
Recital 7
Recital 7
(7) The scope of application of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and food. Therefore, Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety should be amended to exclude medical devices from its scopSince in some cases it is difficult to distinguish between medical devices and cosmetic, medicinal or food products, the strictest legislation should apply in each case.
Amendment 167 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) To ensure that patients harmed will be compensated for any damages and to avert manufacturer's insolvency, manufacturers should be obliged to take out liability insurance with sufficient minimum coverage.
Amendment 183 #
Proposal for a regulation
Recital 37
Recital 37
(37) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificashould enable the public to be adequately informed about devices on the Union market. Adequate levels of access for the public and the healthcare professionals to those parts of Eudamed's electronic systems should enable the public to be adequately informed about devices on the Union market. which provide key information on medical devices that may pose a risk to public health and safety is essential. Access to data should be granted upon request, in accordance with Regulation (EC) No 1049/2001.The electronic system on clinical investigations should serve as tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and, in this case, to report serious adverse events. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities.
Amendment 186 #
Proposal for a regulation
Recital 39
Recital 39
(39) For high-risk medical devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document thatprovide the national authority or the Agency, as relevant, involved in the marketing authorisation procedure, with a full report on the safety and the clinical performance of that device. The full report and a summary thereof should be publicly available via Eudamed.
Amendment 187 #
Proposal for a regulation
Recital 39 a (new)
Recital 39 a (new)
(39a) With invasive devices with a diagnostic and measuring function, Member States should take all necessary measures to prevent the risk of infection and microbial contamination between patients. To this end, the Member States should eliminate the known or foreseeable risks to patient safety by advocating inter alia the safest levels of and guidelines for disinfection and ensure their effective implementation by users and health establishments. In accordance with the provisions of Article 74 of this regulation, the Commission shall ensure that these preventive health protection measures are appropriate.
Amendment 191 #
Proposal for a regulation
Recital 42 a (new)
Recital 42 a (new)
(42a) The conformity assessment procedure should not be applicable for all types of devices. A swift centralised marketing authorisation procedure should be introduced for: - implantable devices and active therapeutic devices intended to be used in direct contact with the heart, the central circulatory system or the central nervous system; - implantable devices used on the spinal column and hip, shoulder and knee joints, with the exception of instruments and accessories used for osteosynthesis; - implantable and invasive devices for aesthetic purposes. A swift decentralised marketing authorisation procedure should be introduced for all other devices of class IIb and class III.
Amendment 196 #
Proposal for a regulation
Recital 46 a (new)
Recital 46 a (new)
(46a) To ensure general market safety, any natural or legal person has the right to make public or distribute in good faith information on a fact, an item of data or an action, as soon as a lack of knowledge of this fact, this item of data or this action appears to present a danger to health or the environment.
Amendment 294 #
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
1a. Where manufacturers of new medical devices submit a market authorisation application and do not have specific reference standards, the Commission shall consult all national authorities and submit the new standards to a group of independent experts. The group of experts shall consider all scientific literature and take account of any minority opinions. The latter shall be included in the opinion issued by the group of experts and be communicated to medical professionals and to patients.
Amendment 300 #
Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 2
Article 8 – paragraph 4 – subparagraph 2
Amendment 304 #
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’, which shall be validated by the authorities responsible for granting or re-evaluating market authorisations, and be carried out by an independent authority which has in no way contributed to the device’s market authorisation or the re-evaluation thereof. The post- market surveillance plan shall set out the process for collecting, recording 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.
Amendment 311 #
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers shall, in response to a reasoned request from a competent authority, consumers’ association, patients’ association or professional healthcare association, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. T or association. Where this involves an authority, they shall cooperate with that authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service. Where this involves an association, all information exchanged in respect of the request shall be notified to the competent authority.
Amendment 313 #
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers shall, in response to a reasoned request from a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service. If there is evidence to assume that a medical device has caused damage, the potentially harmed user, his successor in title, his compulsory health insurance or other third parties affected by the damage may also demand the information referred to in sentence 1 from the manufacturer or his authorised representative. This right to information shall also exist, subject to the conditions set forth in sentence 1, against the competent authorities of the Member States which are responsible for the surveillance of the respective medical device, as well as against any notified body that issued a certificate pursuant to Article 45 or was otherwise involved in the conformity assessment procedure of the medical device in question.
Amendment 318 #
Proposal for a regulation
Article 8 – paragraph 10 a (new)
Article 8 – paragraph 10 a (new)
Amendment 322 #
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – introductory part
Article 11 – paragraph 2 – subparagraph 1 – introductory part
Before placing a device on the market importers shall ensure the following: that the manufacturer is identifiable and has the technical, scientific and financial capacity to produce a medical device compliant with this Regulation, and that importers make available to the national authorities and on their website a report on the investigation procedures attesting to the expertise of the manufacturer.
Amendment 325 #
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point f a (new)
Article 11 – paragraph 2 – subparagraph 1 – point f a (new)
(fa) that the manufacturer has taken out adequate insurance coverage pursuant to Article 8 paragraph 10a (new), unless the importer himself ensures coverage that meets the requirements of this provision.
Amendment 328 #
Proposal for a regulation
Article 11 – paragraph 7
Article 11 – paragraph 7
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and his authorised representative and, if appropriate, take the necessary corrective action to bring that device into conformity, withdraw or recall it. Where the device presents a risk, tThey shall also immediately inform the competent authorities of theall Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 45 for the device in question, giving details, in particular, of the non-compliance and of any corrective action takenand EU notified bodies, specifying the identity of the manufacturer and whether it is part of a group of companies, so that the competent authorities can investigate all the products produced by the manufacturer and the group to which it belongs.
Amendment 380 #
Proposal for a regulation
Article 15
Article 15
Amendment 405 #
Proposal for a regulation
Article 15 a (new)
Article 15 a (new)
Article 15 a Single-use devices and their reprocessing Single-use devices may not be reprocessed for the purposes of reuse on the European market.
Amendment 415 #
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 particular patient who has been implanted with the device. An electronic version of this information shall be kept and made available to the patient upon request by the manufacturer as long as the device is implanted in the patient.
Amendment 424 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 2
Article 16 – paragraph 2 – subparagraph 2
The information shall be written in a way that is readily understood by a lay person. This information shall be supplied to the patient at the time of consent, before the device is implanted. The patients need to know that implants are not permanent and may need to be replaced or removed; patients also need to be informed about the quality of implants and the potential risks associated with them.
Amendment 431 #
Proposal for a regulation
Article 18 – paragraph 5
Article 18 – paragraph 5
5. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 42. The identification number and contact information of the notified body responsible shall also be indicated in any promotional material which mentions that a device fulfils the legal requirements for CE marking.
Amendment 462 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. In the case of devices classified as class III and implantable devicessubmitted for marketing authorisation procedure, other than custom-made or investigational devices, the manufacturer shall draw up a summary ofreport and a summary thereof on the safety and clinical performance. It shall be written in a way that is clear to the intended user. The draft of this summaryreport shall be part of the documentation to be submitted to the noatified body involved in the conformity assessmeonal authority or the Agency, as relevant, in accordance with Article 42 and shall be validated by that bodyvolved in the marketing authorisation procedure.
Amendment 463 #
Proposal for a regulation
Article 26 – paragraph 1 a (new)
Article 26 – paragraph 1 a (new)
1a. The full report and the summary shall be made available to the public via Eudamed.
Amendment 469 #
Proposal for a regulation
Article 27 – paragraph 1 – point a
Article 27 – paragraph 1 – point a
(a) to enable the public to be adequately informed about devices placed on the market as well as devices removed from the market, about the corresponding certificates issued by notified bodies and about the relevant economic operators;
Amendment 474 #
Proposal for a regulation
Article 27 – paragraph 3
Article 27 – paragraph 3
3. The data shall be entered into Eudamed by the Agency, the Member States, notified bodies, economic operators and, sponsors, healthcare professionals and patients as specified in the provisions concerning the electronic systems referred to in paragraph 2.
Amendment 513 #
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 unannounced on-site visit to each notified body.
Amendment 540 #
Proposal for a regulation
Article 41 a (new)
Article 41 a (new)
Article 41 a General principles regarding the marketing authorisation 1. None of the following devices may be placed on the market within the Union unless a Union marketing authorisation has been granted trough a centralised procedure: - implantable devices and active therapeutic devices intended for use in direct contact with the heart, the central circulatory system or the central nervous system; - implantable devices for spinal cords and hip, shoulder and knee joints, with the exception of osteosynthesis instruments and accessories; - implantable and invasive devices for aesthetic purposes. 2. None of the following devices may be placed on the market of a Member State unless a national marketing authorisation has been granted by the competent authority of the Member State trough a decentralised procedure: - class IIb devices other than devices listed in paragraph 1 of Article 41a - class III devices other than devices listed in paragraph 1 of Article 41a
Amendment 570 #
Proposal for a regulation
Article 44 – paragraph 1
Article 44 – paragraph 1
1. Notified bodies shall notify the Commission of applications for conformity assessments for devices classified as class III, with the exception of applications to supplement or renew existing certificates. 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 noConformity assessments for devices classified as class III shall be carried out by manufacturers under the authority of Member States. Manufacturers shall be required to provide evidence of the medical and socio-economic benefits of new devices placed on the market. They shall also be required to provide evidence of their reliability and safety. That evidence shall be provided scientificationlly and the accompanying documents to the MDCGimpartially.
Amendment 573 #
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
Amendment 580 #
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
Amendment 592 #
Proposal for a regulation
Article 44 – paragraph 6
Article 44 – paragraph 6
6. 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 commercan industrially confidential nature.
Amendment 626 #
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, the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission. The Commission shall also ensure that healthcare professionals and patients have access to the electronic system. Access to data from the database should be granted to the public, in accordance with Regulation (EC) No 1049/2001.
Amendment 745 #
Proposal for a regulation
Article 82 – paragraph 2
Article 82 – paragraph 2
2. Experts and other third parties invited by the MDCG on a case-by-case basis shall be requested to declare their interests in the issue in question and their declaration of interest shall be permanently accessible to the public.
Amendment 757 #
Proposal for a regulation
Article 94 – paragraph 7
Article 94 – paragraph 7
7. DClass IIb and class III devices falling within the scope of this Regulation in accordance with point (e) of Article 1(2)which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to the application of this Regulation which are already on the market shall be subject to a market authorisation as referred to in Article 41. Within a transitional period of six months following the date this Regulation enters into force, the manufacturers or the entity responsible for placing the devices on the market must report to the centralised or decentralised authorisation body -as applicable- the class IIb and class III medical devices they have placed on the market, together with the results of the conformity assessment procedure in order to be allowed to continue to be marketed for a period of five years of the date this Regulation enters into force. Once this period has expired, they may not continue to be placed on the market unless an authorisation has meanwhile been granted or an application for the granting of authorisation has been filed. All other devices falling within the scope of this Regulation which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to the application of this Regulation which are already on the market may continue to be placed on the market and put into service in the Member States concerned.
Amendment 765 #
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – introductory part
Annex 1 – part II – point 7 – point 7.4 – introductory part
7.4. The devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate the risks posed by substances that may leach or leak from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 , and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health andor which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) , or are known or presumed endocrine disrupters pursuant to Commission Recommendation (2013/.../EU) on criteria for the identification of endocrine disrupters.
Amendment 766 #
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – introductory part
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – introductory part
Amendment 768 #
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – indent 3 – paragraph 1
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – indent 3 – paragraph 1
shall not contain, in a concentration of 0.1% by mass of the plasticised material or above, phthalator above by mass per homogeneous material, substances which are classified as carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008, or substances identified as endocrine disrupters pursuant to the first subparagraph, unless the manufacturer can show that there are no suitable safer substances or devices without these substances. In case the manufacturer can show that there are no suitable safer substances or devices without these substances, these devices shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as devices containing phthalates. If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, tsubstances which are classified as carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B or substances identified as endocrine disrupters. The manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures. (Linked to the amendment by the same authors to the first eight words of this subparagraphOr. en (AT4AM aberration).)
Amendment 769 #
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.6
Annex 1 – part II – point 7 – point 7.6
7.6. The devices shall be designed and manufactured in such a way as to reduce to a minimum the risks linked to the size and the properties of particles used. Special care shall be applied when devices contain or consist of nanomaterial that can be released into the patient's or user's body. The manufacturer shall provide specific evidence that the use of the nanomaterial complies with the general safety and performance requirements within the technical documentation. The specific evidence has to be shown to respond to the specific characteristics of the nanomaterial. The manufacturer shall also provide within the instructions for use, information on residual risks for patients and, if applicable, on appropriate precautionary measures.
Amendment 770 #
Proposal for a regulation
Annex 1 – part II – point 8 – point 8.7 a (new)
Annex 1 – part II – point 8 – point 8.7 a (new)
8.7a. Medical device manufacturers shall notify their users of the levels of disinfection required to ensure patient safety and of all available methods for achieving those levels of disinfection. Manufacturers shall be required to test their devices using all methods designed to ensure patient safety and to substantiate any decision to reject a solution, either by demonstrating that it is ineffective or by demonstrating that it will cause damage impairing the medical usefulness of their devices to a significantly greater degree than other solutions that they themselves recommend.