Activities of Marina YANNAKOUDAKIS related to 2012/0266(COD)
Shadow reports (1)
REPORT 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 PDF (1 MB) DOC (1 MB)
Amendments (54)
Amendment 156 #
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
Amendment 166 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) To ensure that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by medical devices, manufacturers shall be obliged to take liability insurance with appropriate coverage.
Amendment 173 #
Proposal for a regulation
Recital 31 a (new)
Recital 31 a (new)
(31a) Due to the highly complex nature of single use devices and their reprocessing across the EU it is first important to consider the impact any significant policy change may have on the safety of patients, clinicians and the other stakeholders involved. For this reason an accountable and transparent impact assessment should first be conducted that takes account of the economic, social (including health systems) and environmental consequences of policy action or inaction. If the impact assessment proves feasible the findings should be presented in a report to all relevant stakeholders.
Amendment 174 #
Proposal for a regulation
Recital 32
Recital 32
(32) Patients who are implanted with a device should be given where possible in advance essential information related to the implanted device allowing it to be identified and containing any necessary warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls.
Amendment 181 #
Proposal for a regulation
Recital 35
Recital 35
(35) Transparency and better information that is understandable, reliable, objective, easily accessible and non-promotional are essential to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
Amendment 189 #
Proposal for a regulation
Recital 42
Recital 42
(42) For high risk medical devices, competent authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right, on scientifically valid grounds, to scrutinise the preliminary assessment conducted by notified bodies, in particular regarding novel devices, devices for which a novel technology is being used, devices belonging to a category of devices with increased serious incident rates, or devices for which significant discrepancies in the conformity assessments by different notified bodies have been identified in respect of substantially similar devices. The process foreseen in this Regulation does not prevent a manufacturer from informing voluntarily a competent authority of his intention to file an application for conformity assessment for a high risk medical device before submitting the application to the notified body.
Amendment 197 #
Proposal for a regulation
Recital 47
Recital 47
(47) The rules on clinical investigations should be in line with major international guidance in this field, such as the international standard ISO 14155:2011 or any subsequent version of it on good clinical practice for clinical investigations of medical devices for human subjects and the most recent (2008) version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects to ensure that clinical investigations conducted in the Union are accepted elsewhere and that clinical investigations conducted outside the Union in accordance with international guidelines can be accepted under this Regulation.
Amendment 201 #
Proposal for a regulation
Recital 50
Recital 50
(50) Sponsors should report certain adverse events, including Serious adverse Device Effects, device effects and device deficiencies occurring during clinical investigations to the Member States concerned, which should have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation. Such information should be communicated to the other Member States.
Amendment 227 #
Proposal for a regulation
Article 1 – paragraph 2 – point f a (new)
Article 1 – paragraph 2 – point f a (new)
(fa) To devices that are composed of substances or combination of substances intended to be ingested and that are absorbed by or dispersed in the human body that based on robust scientific evidence pose no adverse health implications to patient safety.
Amendment 240 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 2
Article 2 – paragraph 1 – subparagraph 1 – point 2
(2) ‘'accessory to a medical device’' means an article which, whilst not being a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable or assist the device(s) to be used in accordance with its/their intended purpose(s) or to specifically assist the medical functionality of the device(s) in view of its/their intended purpose(s);
Amendment 267 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 39 – indent 2 – point iii
Article 2 – paragraph 1 – subparagraph 1 – point 39 – indent 2 – point iii
(iii) hospitalisation or extending the duration ofprolongation of patient hospitalisation,
Amendment 275 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, at the request of a Member State, or after consultation wits own initiativeh the Member States, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 279 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Commission shall ensure the sharing of expertise between Member States and relevant stakeholders including patient groups in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products in order to determine the appropriate regulatory status of a product, or category or group of products.
Amendment 282 #
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Devices that are manufactured and used within a single health institution shall be considered as being put into service. The provisions regarding CE marking referred to in Article 18 and the obligations laid down in Articles 23 to, 26 and 27 shall not apply to those devices, provided that manufacture and use of those devices occur under the health institution's single quality management system.
Amendment 302 #
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’. Analysis and reporting of post-market surveillance shall also be conducted by independent organisations. 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 306 #
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 2
Article 8 – paragraph 6 – subparagraph 2
If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures, including the immediate reporting to the European databank on medical devices (Eudamed)set up by the Commission Decision 2010/227/EU.
Amendment 310 #
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, or from a legitimate health institution or 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. 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.
Amendment 317 #
Proposal for a regulation
Article 8 – paragraph 10 a (new)
Article 8 – paragraph 10 a (new)
Amendment 339 #
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 356 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point b a (new)
Article 13 – paragraph 1 – subparagraph 1 – point b a (new)
(ba) An agreed set of skills and competencies decided by competent national authorities, which are relevant to the product area in which the qualified person is operating.
Amendment 359 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 3
Article 13 – paragraph 1 – subparagraph 3
This paragraph shall not apply to manufacturers of custom-made devices who are registered pharmacies, or micro- enterprises as defined by Commission Recommendation 2003/361/EC.
Amendment 367 #
Proposal for a regulation
Article 13 – paragraph 2 – point d
Article 13 – paragraph 2 – point d
(d) in the case of investigational devices, that the statement referred to in point 4.1 of Chapter II of Annex XIV is issued and the obligations on Serious Adverse Events reporting are fulfilled.
Amendment 376 #
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 1 – point c
Article 14 – paragraph 1 – subparagraph 1 – point c
(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected; this includes the reuse of a device outside of the specifications set out in the manufacturer's instructions for use.
Amendment 385 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person, including health institutions as specified at Art. 4.4, who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation.
Amendment 393 #
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
3. In the case of reprocessing of single-use devices for critical use, only reprocessing that is considered safe according to the latest scientific evidence may be carried out. Scientific evidence also needs to take account of cases where the situation is critical due to the severity of the disease that is being treated.
Amendment 412 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The manufacturer of anCommission shall be empowered to adopt delegated acts in accordance with Article 89 identifying for which implantable devices the manufacturer shall provide together with the device an implant card, which can be provided by electronic form or other means containing the information referred to in paragraph 2 which shall be made available to the particular patient who has been implanted with the device.
Amendment 427 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The EU declaration of conformity shall state that fulfilment of the requirements specified in this Regulation has been demonstrated. It shall be continuously updated. The minimum content of the EU declaration of conformity is set out in Annex III. It shall be translated into the official Union language or languages required by the Member State(s) in which the device is made availableEnglish in addition to a version in the language of the member state (if required) where the manufacturer or authorized representative has their registered place of business.
Amendment 441 #
Proposal for a regulation
Article 24 – paragraph 1 – introductory part
Article 24 – paragraph 1 – introductory part
1. For devices, other than custom-made and investigational devices, a single system for Unique Device Identification shall be put in place in the Union. The UDI system shall allow the identification and traceability of devices, be coherent if possible with the global regulatory approach for UDI in medical devices, and shall consist of the following:
Amendment 459 #
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 summaryprovide a report of safety and clinical performance, including full results of clinical studies and trials. It shall be written in a way that is clear to the intended user, differentiating between the information needs of patients and healthcare professionals. 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. The summary shall also be made public.
Amendment 468 #
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 via a central information point where patients can ask, seek and find information about devices placed on the market, about the corresponding certificates issued by notified bodies and about the relevant economic operators; The Commission should develop guidelines in consultation with stakeholders, including Member State competent authorities, the research community and patient and consumer organisations, and to specify the exact content and format of the information that should be published.
Amendment 477 #
Proposal for a regulation
Article 27 – paragraph 4
Article 27 – paragraph 4
4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, healthcare professionals, sponsors and the public to the extent defined in the provisions referred to in paragraph 2.
Amendment 488 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Notified bodies shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this Regulation. In this respect, permanent "in house" administrative, technical and scientific personnel, with medical, technical and where possible pharmacological knowledge is crucial. Permanent "in house" shall be used, but notified bodies must have the flexibility to hire external experts on an ad hoc and temporary basis as and when needed. Minimum requirements to be met by notified bodies are set out in Annex VI.
Amendment 506 #
Proposal for a regulation
Article 33 – paragraph 9
Article 33 – paragraph 9
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly. Details of the notification, such as the class and the typology of devices shall be made publicly available.
Amendment 527 #
Proposal for a regulation
Article 37 – paragraph 3 – subparagraph 1
Article 37 – paragraph 3 – subparagraph 1
Where the Commission ascertains that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification if necessary. A report with the opinions of Member States should be made publicly available by the European Commission after the assessment.
Amendment 533 #
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. The Member State where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation. The fees shall be transparent and proportionate in nature and be subject to member state labour markets.
Amendment 545 #
Proposal for a regulation
Article 42 – paragraph 8 a (new)
Article 42 – paragraph 8 a (new)
8a. The Member States may decide on the minimum frequency of unannounced factory inspections and sample checks to be conducted by notified bodies in accordance with Section 4.4 of Annex VII, taking into account the risk-class, the type of device and specific factors related to the manufacturers in a Member State. In case such a decision is made, the Commission should be kept informed.
Amendment 549 #
Proposal for a regulation
Article 42 – paragraph 10 – subparagraph 1 – indent 2
Article 42 – paragraph 10 – subparagraph 1 – indent 2
Amendment 563 #
Proposal for a regulation
Article 44
Article 44
Amendment 621 #
Proposal for a regulation
Article 51 – paragraph 6 – subparagraph 2
Article 51 – paragraph 6 – subparagraph 2
Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In the assessment, the view of at leastmore than 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.
Amendment 623 #
Proposal for a regulation
Article 53 – paragraph 1 – point b
Article 53 – paragraph 1 – point b
(b) the exchange of information between the Member States and between them and the Commission in accordance with Article 56; All relevant updates to the information concerning an investigation should be posted on the database, such as measures taken by Member States to terminate, suspend or modify an investigation, as well as updated information on the benefit-risk balance or any urgent safety measures taken.
Amendment 631 #
Proposal for a regulation
Article 59 – paragraph 1 – point d
Article 59 – paragraph 1 – point d
(d) new findings in relation to any event referred to in points (a) to (c). Information regarding incidents that are caused by user errors should also be collected, as they are a major source of incidents with medical devices. This information can contribute to improve the safety and knowledge of the device. The Regulation should also provide for Member States to put in place non- electronic formats of reporting to ensure that patients who do not have online access are able to report.
Amendment 640 #
Proposal for a regulation
Article 61 – paragraph 3 – subparagraph 2
Article 61 – paragraph 3 – subparagraph 2
The Member States shall coordinate between them the development of standard web-based structured forms for, as well as non-electronic formats for the reporting of serious incidents by healthcare professionals, users and patients.
Amendment 642 #
Proposal for a regulation
Article 62 – paragraph 1 – introductory part
Article 62 – paragraph 1 – introductory part
1. The Commission shall, in collaboration with the Member States, set updevelop further the existing European databank on medical devices (Eudamed) set up by the Commission Decision 2010/227/EU and manage an electronic system to collate and process the following information:
Amendment 647 #
Proposal for a regulation
Article 62 – paragraph 3
Article 62 – paragraph 3
3. The Commission shall ensure that healthcare professionals and the public have appropriate levels offull access to the electronic system in line with existing data protection and intellectual property right legislation.
Amendment 790 #
Proposal for a regulation
Annex 1 – part III – point 19 – point 19.1 – paragraph 1 – point d
Annex 1 – part III – point 19 – point 19.1 – paragraph 1 – point d
(d) Labels shall be provided in a human- readable format but mayand shall be supplemented by machine-readable forms, such as radio- frequency identification (RFID) or bar codes.
Amendment 793 #
Proposal for a regulation
Annex 1 – part III – point 19 – point 19.3 – point q
Annex 1 – part III – point 19 – point 19.3 – point q
(q) For devices intended for use by lay persons, the circumstances when the user should consult with a healthcare professional. Elements in the instructions for use for patients should be reviewed with the input of patient organisations to ensure they truly correspond to patients' needs and are understandable and accessible.
Amendment 796 #
Proposal for a regulation
Annex 2 – paragraph 1 – point 5 – paragraph 1 – introductory part
Annex 2 – paragraph 1 – point 5 – paragraph 1 – introductory part
The documentation shall contain a summary ofll available information related to
Amendment 811 #
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 2
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 2
This presupposes the permanent availability within its organisation of sufficient scientific personnel who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Regulation and, in particular, those set out in Annex I. Permanent "in house" staff shall be used, but notified bodies must have the flexibility to hire external experts on an ad hoc and temporary basis as and when needed.
Amendment 815 #
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.2
Annex 6 – point 3 – point 3.1 – point 3.1.2
3.1.2. At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a notified body shall have within its organisation the necessary administrative, technical and scientific personnel with technmedical, technical and where possible pharmacological knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks, including the assessment of clinical data.
Amendment 822 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – introductory part
Annex 6 – point 3 – point 3.2 – point 3.2.4 – introductory part
3.2.4. Notified bodies shall have available personnel with clinical expertise, on a permanent basis, personnel with expertise in clinical investigation design, medical statistics, clinical patient management, good clinical practice in the field of clinical investigations and where possible pharmacology. Permanent "in house" staff shall be used, but notified bodies must have the flexibility to hire external experts on an ad hoc and temporary basis as and when needed. This personnel shall be integrated in the notified body's decision-making process in a steady way in order to:
Amendment 830 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.5 – indent 5 a (new)
Annex 6 – point 3 – point 3.2 – point 3.2.5 – indent 5 a (new)
- Conformity assessment bodies which are notified for class III devices shall submit to the MDCG the list of all internal and external experts which perform the evaluation of the clinical and non-clinical parts of the conformity assessment. The MDCG is entitled to verify the appropriate qualification of the experts chosen and will publish the list.
Amendment 856 #
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.8 – paragraph 1
Annex 7 – part III – point 6 – point 6.8 – paragraph 1
All devices intended to be used for aphaeresis, such as aphaeresis machines, sets, connectors and solutions, are in class IIIB.
Amendment 891 #
Proposal for a regulation
Annex 13 – point 2 a (new)
Annex 13 – point 2 a (new)
2 a. the involvement of independent scientific bodies such as academic institutions or medical societies in the collection and/or analysis of the clinical data
Amendment 895 #
Proposal for a regulation
Annex 13 – point 5 a (new)
Annex 13 – point 5 a (new)
5 a. All clinical data collected by the manufacturer as part of a PMCF should be made accessible to health professionals.