On 22 October, the European Parliament (EP) voted in plenary on one of the most discussed pieces of legislation in recent months, the proposals for Regulations on Medical Devices and In Vitro Diagnostic (IVD) Medical Devices. The newly-approved rules will bring more transparency during the entire process. Some provisions were rejected, such as the centralised pre-market authorisation system (PMA) and the provision stating that certain devices may only be supplied upon medical prescription.
24 October, 2013 - For the first time, the IVD Medical Devices proposal was debated at the beginning, with the subsequent amendments voted by Members of the European Parliament (MEPs) in order to ensure patient safety through stricter monitoring and certification procedures.
Better access to clinical data will now ensure that patients and healthcare professionals alike will be up-to-date on the latest advancements on this field. This will allow professionals to take the best decision on which devices to use on the basis of an EU database.
Reprocessing of devices labelled as single use will be possible following a strict process that will be allowed if the person or institution ensures the traceability of the process. Furthermore, a list of devices unsuitable for reprocessing would be created. This provision will generate an additional layer of safety for patients. EPHA believes that, whatever the purpose of a medical device, unequivocal information should be provided to patients regarding reprocessing.
With the aim of tightening up the process, MEPs approved a rule stating that placing a CE mark (mandatory conformity marking for certain products sold within the European Economic Area -EEA) on a medical device will be allowed only by a certain group of notified bodies. A permanent group of in-house experts will be made mandatory to assess new devices what would ensure that faulty devices will not be placed on the market.
The much-discussed centralised pre-market authorization system (PMA) was rejected by MEPs. This proposal was controversial in the sense that it could have potentially run the risk of delays for patients in accessing life-saving medical devices.
Certain self-tests will now be available without medical prescription. A rule was approved which, by derogation, allows Members States to maintain or introduce national provisions allowing special class D tests to be available without prescription. MEPS called for establishing an ethics committee to deal with ethical aspects of such tests. In addition, provisions for informed consent of patients and genetic counselling were introduced.
For more information please see the European Parliament Press Release _ Medical implants: better controls and traceability to ensure patients’ safety
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