41 Amendments of Michèle RIVASI 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 152 #
Proposal for a regulation
Recital 8
Recital 8
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 170 #
Proposal for a regulation
Recital 31
Recital 31
(31) The findings of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), established by Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealIn order to comply with waste management hierarchy set up ing Decision 2004/210/EC, in its scientific opinion of 15 April 2010 on the safety of reprocessed medical devices marketed for single-use, and of the Commission in its report of 27 August 2010 to the European Parliament and the Council on the issue of reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC, call for regulation of the reprocessing of single-use devices in order to ensure a high level of protection of health and safety whilst allowing this practice to further develop under clear conditions. By reprocessing a single-use device its intended purpose is modified and the reprocessor should therefore be considered the manufacturer of the reprocessed devicirective 2008/98/EC, all devices should be reusable as a rule and it should be for the manufacturer to provide justification based on sufficient scientific evidence - related to the safety of the patient or of any user - as derogation to that rule.
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 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 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 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 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 438 #
Proposal for a regulation
Article 22 a (new)
Article 22 a (new)
Article 22 a Responsibility in case of damage caused to the patient by a class IIb or class III medical device The manufacturer will be held as legally responsible for the damage caused by a class IIb or class III medical device to the patient, unless he can prove the damage was caused by improper application by the healthcare professional or the patient, where relevant.
Amendment 455 #
Proposal for a regulation
Article 26 – title
Article 26 – title
Summary of safety and clinical performance report
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 542 #
Proposal for a regulation
Article 42 – paragraph 2 – subparagraph 1
Article 42 – paragraph 2 – subparagraph 1
Manufacturers of devices classified as class IIb and III, other than custom-made or investigational devices, shall be subject to a conformity assessmentmarketing authorisation based on full quality assurance, prototype and design dossier examination as specified in Annex VIII. Alternatively, the manufacturer may choose to apply a conformity assessmentmarketing authorisation based on type examination as specified in Annex IX coupled with a conformity assessment based on product conformity verification as specified in Annex X. Where the manufacturer cannot provide a prototype, it will be the manufacturer's responsibility to duly justify it.
Amendment 543 #
Proposal for a regulation
Article 42 – paragraph 3
Article 42 – paragraph 3
Amendment 544 #
Proposal for a regulation
Article 42 – paragraph 4
Article 42 – paragraph 4
4. Manufacturers of devices classified as class IIa, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance as specified in Annex VIII, except for its Chapter II, with assessment of the prototype and the design documentation within the technical documentation on a representative basis. Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annex II coupled with a conformity assessment based on product conformity verification as specified in Section 7 of Part A or Section 8 of Part B of Annex X.
Amendment 553 #
Proposal for a regulation
Article 42 – paragraph 11 a (new)
Article 42 – paragraph 11 a (new)
11a. The Agency, the national competent authority or the notified bodies, as relevant, shall keep and store one prototype of each device they have received from the manufacturer and assessed, for at least five years after the end of the assessment.
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 632 #
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1 a (new)
Article 61 – paragraph 1 – subparagraph 1 a (new)
Point a) of this Paragraph shall also apply to healthcare professional in contact with the patients harmed.
Amendment 696 #
Proposal for a regulation
Article 74 – paragraph 1
Article 74 – paragraph 1
1. Where a Member State, after having performed an evaluation which indicates a potential risk related to a device or a specific category or group of devices considers that the making available on the market or putting into service of such device or specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in order to protect the health and safety of patients, users or other persons or other aspects of public health, it mayshall take any necessary and justified provisional measures.
Amendment 697 #
Proposal for a regulation
Article 74 – paragraph 3 – subparagraph 2
Article 74 – paragraph 3 – subparagraph 2
On duly justified imperative grounds of urgency relating to the health and safety of humans, or in case of lack of action by Member States in a situation of known risk, the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(4).
Amendment 743 #
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 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, tThe declaration of interests shall be accessible to the public. This ArticleParagraph shall not apply to the representatives of stakeholder organisations participating in the sub- groups of the MDCG.
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.