Activities of Antonyia PARVANOVA 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 (33)
Amendment 89 #
Proposal for a regulation
Recital 32
Recital 32
(32) Patients who are implanted with a device should be given essential information related to the implanted device allowing it to be identified and containing information about the main characteristic of the device, the potential adverse effects, a warning of the potential health risks, post-operative follow-up care measures and 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 91 #
Proposal for a regulation
Recital 39
Recital 39
(39) For high-risk medical devices, manufacturers should summarise the main draft a report of the safety and performance aspects of the device and the outcome of the clinical evaluation in a document tha. A summary of the safety and performance report should be publicly available.
Amendment 94 #
Proposal for a regulation
Article 1 – paragraph 4 – subparagraph 1
Article 1 – paragraph 4 – subparagraph 1
Where a device, when placed on the market or used in accordance with the manufacturer’s instructions, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in Article 1(10) of that Directive, with action ancillary to that of the device, that device shall be assessed and authorised in accordance with this Regulation following consultation with the national medicine agency or with the European Medicines Agency.
Amendment 95 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 1
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 1
and which does not achieve its principal intended actionurpose by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
Amendment 102 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 32
Article 2 – paragraph 1 – subparagraph 1 – point 32
(32) ‘clinical evaluation’ means the assessment and analysis of clinical data pertaining to a device in order to verify the safety and, performance and efficacy of the device when used as intended by the manufacturer;
Amendment 106 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 37
Article 2 – paragraph 1 – subparagraph 1 – point 37
(37) ‘sponsor’ means an individual, company, institution or organisation which takes responsibility for the initiation and, management or funding of a clinical investigation;
Amendment 108 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Commission shall ensure the sharing of expertise between Member State, by means of implementing act determine the regulatory status of border line products on the basis of the opinion of the EU multidisciplinary experts group composed of experts in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, and food and, if necessary, other products in order to determine the appropriate regulatory status of a product, or category or group of products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 109 #
Proposal for a regulation
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2 a. For products or groups of products composed of substances or combination of substances that are intended to penetrate inside the body, either through a body orifice or through the surface of the body, which have been considered as medical devices by the multidisciplinary expert group, the Commission shall, by means of implementing acts, determine the risk classification on the basis of the actual risks and on the ground of valid scientific evidence. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 120 #
Proposal for a regulation
Article 15 – paragraph 6 a (new)
Article 15 – paragraph 6 a (new)
6a. The Commission shall, by means of implementing acts, and in collaboration with the International medical devices regulatory forum and international standardisation bodies, define a clear set of high quality and safety standards for reprocessing of single use devices, including specific requirements for the manufacturers of reprocessed devices. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 125 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 1 – point c a (new)
Article 16 – paragraph 2 – subparagraph 1 – point c a (new)
(ca) a short description of the characteristics of the devices, including the materials used;
Amendment 126 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 1 – point c b (new)
Article 16 – paragraph 2 – subparagraph 1 – point c b (new)
(cb) the potential adverse events that might occur on the basis of the data from the clinical evaluation and investigation.
Amendment 127 #
Proposal for a regulation
Article 16 – paragraph 2 a (new)
Article 16 – paragraph 2 a (new)
2a. Member States may introduce national provisions requiring that the implant card also includes information on post-operative follow-up care measures and that it is signed by both the patient and the surgeon responsible for the surgery.
Amendment 175 #
Proposal for a regulation
Recital 32
Recital 32
(32) Patients who are implanted with a device should be given essential information related to the implanted device allowing it to be identified and containing information about the main characteristic of the device, the potential adverse effects, a warning of the potential health risks, post-operative follow-up care measures and 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 185 #
Proposal for a regulation
Recital 39
Recital 39
(39) For high-risk medical devices, manufacturers should summarise the maindraft a report of the safety and performance aspects of the device and the outcome of the clinical evaluation in a document tha. A summary of the safety and performance report should be publicly available.
Amendment 187 #
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 Article shall not apply to the representatives of stakeholder organisations participating in the sub- groups of the MDCGmade publicly available on the European Commission web site.
Amendment 188 #
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 requesRepresentative of stakeholder organizations participating in the sub- groups of the MDCG shall declare any direct and indirect interests they may have in the medical device industry and updated tohis declare their interests in the issue in questionation whenever a relevant change occurs. The declaration of interests shall be made publicly available on the European Commission web site. This shall not apply to representatives of the medical devices industry.
Amendment 228 #
Proposal for a regulation
Article 1 – paragraph 4 – subparagraph 1
Article 1 – paragraph 4 – subparagraph 1
Where a device, when placed on the market or used in accordance with the manufacturer's instructions, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in Article 1(10) of that Directive, with action ancillary to that of the device, that device shall be assessed and authorised in accordance with this Regulation following consultation with the national medicine agency or with the European Medicines Agency.
Amendment 234 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 1
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 1
and which does not achieve its principal intended actionurpose by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
Amendment 252 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 16
Article 2 – paragraph 1 – subparagraph 1 – point 16
(16) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
Amendment 261 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 32
Article 2 – paragraph 1 – subparagraph 1 – point 32
(32) ‘clinical evaluation’ means the assessment and analysis of clinical data pertaining to a device in order to verify the safety and, performance and efficacy of the device when used as intended by the manufacturer;
Amendment 265 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 37
Article 2 – paragraph 1 – subparagraph 1 – point 37
(37) ‘sponsor’ means an individual, company, institution or organisation which takes responsibility for the initiation and, management or funding of a clinical investigation;
Amendment 280 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Commission shall ensure the sharing of expertise between Member States 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 productsby means of implementing act, determine the regulatory status of border line products on the basis of the opinion of the EU multidisciplinary experts group composed of experts in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, and food. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 281 #
Proposal for a regulation
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2a. For products or groups of products composed of substances or combination of substances that are intended to penetrate inside the body, either through a body orifice or through the surface of the body, which have been considered as medical devices by the multidisciplinary expert group, the Commission shall, by means of implementing acts, determine the risk classification on the basis of the actual risks and on the ground of valid scientific evidence. Those implementing acts shall be adopted in accordance with the Examination procedure referred to in Article 88(3).
Amendment 402 #
Proposal for a regulation
Article 15 – paragraph 6 a (new)
Article 15 – paragraph 6 a (new)
6a. The Commission shall, by means of implementing acts, and in collaboration with the International medical devices regulatory forum and international standardisation bodies, define a clear set of high quality and safety standards for reprocessing of single use devices, including specific requirements for the manufacturers of reprocessed devices.
Amendment 418 #
Proposal for a regulation
Article 16 – paragraph 2 a (new)
Article 16 – paragraph 2 a (new)
2a. Member States may introduce national provisions requiring that the implant card includes also information on post-operative follow-up care measures and that is signed by both the patient and the surgeon responsible for the surgery.
Amendment 421 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 1 – point c a (new)
Article 16 – paragraph 2 – subparagraph 1 – point c a (new)
(ca) a short description of the characteristics of the devices, including the materials used;
Amendment 423 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 1 – point c b (new)
Article 16 – paragraph 2 – subparagraph 1 – point c b (new)
(cb) the potential adverse events that might occur on the basis of the data from the clinical evaluation and investigation.
Amendment 454 #
Proposal for a regulation
Article 26 – title
Article 26 – title
Summary of safety and clinical performance report
Amendment 461 #
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 ofreport on the safety and clinical perinformance. It shall be written in a way that is clear to the intended usertion collected during the clinical investigation and a summary written in a way that is comprehensive and easy to understand. The draft of this summary report 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 of the safety and clinical performance report should be made publicly available via the European databank as set in Article 27.
Amendment 464 #
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the report and in the summary of safety and clinical perinformancetion. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(2).
Amendment 473 #
Proposal for a regulation
Article 27 – paragraph 2 – point f a (new)
Article 27 – paragraph 2 – point f a (new)
(fa) the electronic system on safety and clinical data reports and the safety and clinical report summaries referred to in Article 26.
Amendment 742 #
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 Article shall not apply to the representatives of stakeholder organisations participating in the sub- groups of the MDCGmade publicly available on the European Commission web site.
Amendment 744 #
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 requesRepresentative of stakeholder organizations participating in the sub- groups of the MDCG shall declare any direct and indirect interests they may have in the medical device industry and updated tohis declare their interests in the issue in questionation whenever a relevant change occurs. The declaration of interests shall be made publicly available on the European Commission web site. This shall not apply to representatives of the medical devices industry.