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The European Association of Hospital Pharmacists (EAHP) produces a weekly email of the top European policy developments and other news of interest to hospital pharmacists called the European Union (EU) Monitor. Below, EAHP Policy and Advocacy Officer Richard Price presents some recent highlights.
New pan-European proposals for medical device regulation (EAHP EU Monitor, 28 September 2012)
The European Commission has published its proposals for the future regulation of medical devices with the aim of improving assessment procedures, access to information and traceability procedures.
In relation to healthcare professionals, it is the Commission's expressed hope that the proposals will enable better provision of information on the benefits of particular devices to patients as well as residual risks. This will be provided by an extension of the existing database on medical devices (Eudamed), with access to non-confidential data provided to patients, healthcare professionals and the public at large. The Commission hopes this will help healthcare professionals in making the best use of medical equipment in its treatment and care of patients.
Other key aspects of the Commission's proposals are presented below.
Medical device assessment procedures
Criticism has been made that of the up to 80 notified bodies across Europe empowered to assess devices and issue a pan-European CE mark, not all are maintaining the same standards and rigour in their assessment processes. The Commission's proposals will enable stronger supervision of independent assessment bodies by national authorities, with new details to be given on how notified bodies must carry out their evaluations before and after market release (eg, the documents to be provided, the scope of verification, the obligation to carry out unannounced on-the-spot inspections, checks of samples). The Commission's proposal will also create stricter requirements for clinical evidence to support assessments of medical devices. It …
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.