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Advancing healthcare policy

Medical devices and Europe

Medical devices and Europe: In brief

  The overhaul of the European legislative framework for medical devices offers an opportunity to improve patient safety, notably by requiring that high-risk medical devices undergo clinical evaluation before they can be placed on the market.

In 2012, the PIP breast implant scandal once again highlighted the limitations of the current European system for regulating high-risk medical devices.

Under current rules, there is no need to obtain Marketing Authorisation (MA) or to demonstrate a positive harm-benefit balance in clinical use in order to obtain the required “CE” (European conformity) marking: the device has only to meet certain technical specifications. And rather than assigning responsibility for the regulation of this market to health authorities, the role of overseeing medical device manufacturers is outsourced to various “notified bodies".

Strengthening the entire legislative framework
The entire legislative framework needs strengthening. In the interests of patients, the overhaul of this framework needs to produce ambitious medical devices regulations that are as ground-breaking as was the 1965 Directive on medicinal products.

High-risk medical devices, in particular implantable devices, should only be granted a marketing authorisation once they have been demonstrated to represent a genuine therapeutic or diagnostic advance over existing alternatives, and to be safe.

The European Commission's proposals do not go far enough
The European Commission's proposals released in September 2012 only provide for closer surveillance once devices are marketed, and do not require manufacturers to obtain a marketing authorisation before placing high-risk medical devices, such as implantable devices, on the market.

In early October 2013, the Environment and health (ENVI) committee of the European Parliament adopted many amendments that improved the European Commission's original proposals, in particular by giving health authorities a greater role in the evaluation of high-risk medical devices prior to market access.

On 22 October 2013, under pressure from medical device industry lobbies, many of these improvements were rejected at the European Parliament plenary vote. It is now the turn of Member States' health ministers to have their say in European Council meetings.

©Prescrire November 2014