Activities of Philippe BOULLAND 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 (13)
Amendment 15 #
Proposal for a regulation
Recital 2
Recital 2
(2) This Regulation aims to ensure the functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for health professionals, patients, users and operators. At the same time, this Regulation sets high standards of quality and safety for medical devices to meet common safety concerns as regards these products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 TFEU, this Regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market which may then benefit from the principle of free movement of goods. As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for those medical devices by ensuring, among other things, that data generated in clinical investigations is reliable and robust and that the safety of the subjects participating in a clinical investigation is protected.
Amendment 16 #
Proposal for a regulation
Recital 3
Recital 3
(3) Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding devices should be introduced, to improve health and safety for health professionals, patients, users and operators, particularly in the waste disposal chain.
Amendment 17 #
Proposal for a regulation
Recital 13
Recital 13
(13) There is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices. In order to ensure a high level of health protection,and safety protection for health professionals, operators and patients, as well as free movement of goods and, legal certainty for manufacturers and responsibility on their part, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial, with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and manufacture of medical devices, the manufacturers should take special care when using nanoparticles that can be released to the human body and those devices should be subject to the most severe conformity assessment procedure.
Amendment 19 #
Proposal for a regulation
Recital 19
Recital 19
(19) To recognise the important role of standardisation and traceability in the field of medical devices, compliance with harmonised standards as defined in Regulation (EU) No […/…] on European standardisation should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as quality and risk management.
Amendment 20 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21a) The Directive of the European Parliament and of the Council on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (XXth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)1 should be the reference text for ensuring that people working in the vicinity of magnetic resonance imaging equipment when it is functioning are properly protected. ______________ 1 COM(2011)0348.
Amendment 21 #
Proposal for a regulation
Recital 32
Recital 32
(32) Patients who are implanted with a device shouldmust be given clear and easily accessible 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 22 #
Proposal for a regulation
Recital 36
Recital 36
(36) One key aspect is the creation of a central database that should integrate different electronic systems, with the UDI as an integral part of it, to collate and process information regarding medical devices on the market and the relevant economic operators, certificates, clinical investigations, vigilance and market surveillance. The objectives of the database are to enhance overall transparency, to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission, to avoid multiple reporting requirements and to enhance the coordination between Member States. The database will also facilitate the traceability of medical equipment donated or exported to countries outside the EU. Within an internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices (Eudamed) set up by Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices.
Amendment 23 #
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 that should be publicly available and easily accessible.
Amendment 24 #
Proposal for a regulation
Recital 40
Recital 40
(40) The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection andfor health professionals, users and operators, particularly in the waste disposal chain, and for ensuring citizens'’ confidence in the system. Designation and monitoring of notified bodies by the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level.
Amendment 25 #
Proposal for a regulation
Recital 52
Recital 52
(52) In order to better protect the health and safety of health professionals, patients, users and operators, particularly in the waste disposal chain, regarding devices on the market, the vigilance system for medical devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions.
Amendment 26 #
Proposal for a regulation
Recital 53
Recital 53
(53) Healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats. The national competent authorities shouldmust inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents and enable information about them to be disseminated to the countries to which medical equipment is donated or exported.
Amendment 33 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 47
Article 2 – paragraph 1 – subparagraph 1 – point 47
(47) ‘field safety notice’ means the communication sent by the manufacturer to users, waste disposal operators or customers in relation to a field safety corrective action;
Amendment 59 #
Proposal for a regulation
Annex 1 – part II – point 10 – point 10.3 – paragraph 1
Annex 1 – part II – point 10 – point 10.3 – paragraph 1
In the case of biological substances other than those referred to in Sections 10.1. and 10.2., the processing, preservation, testing and handling of those substances shall be carried out so as to provide optimal safety for patients, users and, where applicable, other persons, particularly in the waste disposal chain. In particular, safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.