Activities of Philippe BOULLAND related to 2012/0267(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
Amendments (8)
Amendment 9 #
Proposal for a regulation
Recital 2
Recital 2
(2) This Regulation aims to ensure the functioning of the internal market as regards in vitro diagnostic 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 devices to meet common safety concerns as regards those products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on the Functioning of the European Union, this Regulation harmonises the rules for the placing on the market and putting into service of in vitro diagnostic 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) of the Treaty on the Functioning of the European Union, this Regulation sets high standards of quality and safety for those devices by ensuring, among other things, that data generated in clinical performance studies is reliable and robust and that the safety of subjects participating in clinical performance studies is protected.
Amendment 10 #
Proposal for a regulation
Recital 3
Recital 3
(3) Key elements of the existing regulatory approach, such as the supervision of notified bodies, risk classification, conformity assessment procedures, clinical evidenceinvestigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding in vitro diagnostic medical devices should be introduced, to improve health and safety for health professionals, patients, users and operators, particularly in the waste disposal chain.
Amendment 11 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) 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 12 #
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-ing and waste disposal policyies and stock-hospitals’ management by hospitalsof stock.
Amendment 13 #
Proposal for a regulation
Recital 28
Recital 28
(28) Transparency and better information are essential to empower patients and, healthcare professionals and all others concerned, 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 14 #
Proposal for a regulation
Recital 29
Recital 29
(29) 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 in vitro diagnostic medical devices on the market and the relevant economic operators, certificates, interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies, 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) by further developing the databank set up by Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices.
Amendment 15 #
Proposal for a regulation
Recital 48
Recital 48
(48) In order to better protect health and safety regarding devices on the market, the vigilance system for in vitro diagnostic medical devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions within and outside the EU.
Amendment 16 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 55
Article 2 – paragraph 1 – subparagraph 1 – point 55
(55) ‘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;