What To Expect From The New EU Medical Devices Regime?

Introduction

At the end of September 2012, the European Commission (EC) published two proposals which will fundamentally change placement of medical devices on the EU market. This follows the scandal caused by the French manufacturer (Poly Implant Prothèse) which apparently used industrial silicon instead of medical grade silicone for the manufacture of breast implants, causing potential harm to thousands of women around the world.

Around 500,000 or more different types of medical devices are available on the market. These include a huge spectrum of products, from home-use items like sticking plasters, contact lenses and pregnancy tests to dental filling materials, x-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests. Existing EU legislation has not kept pace with the enormous technological and scientific progress. Additionally, it has been interpreted and implemented differently throughout the EU. Moreover, it has failed to provide access to essential information on medical devices for patients, healthcare professionals and others.

Therefore the EC has published proposals for two new regulations that will ensure a high level of human health and safety, smooth functioning of the internal market and meet the growing expectations of European citizens while preserving an innovation-friendly approach.

Once adopted, one regulation will set rules for in vitro medical devices (IVDs), while the other will cover remaining medical devices, including active implantable medical devices (AIMDs).

Common aspects of the proposed regulations

The new rules envisage stricter and more detailed monitoring and enforcement requirements both for entities responsible for conformity assessments (notified bodies) and for national competent authorities within the EU.

The proposals do not set a pre-marketing authorisation system, but rather a "scrutiny procedure" whereby a Medical Device Coordination Group (MDCG), composed of EU Member State experts and chaired by the EC, will review and have the opportunity to comment on draft summaries of conformity assessments of high-risk devices. Notified bodies will be required to give "due consideration" to comments received from the MDCG, and justify not following those comments.

Other significant features of the two proposed regulations include:

more unannounced inspections by notified bodies and member state authorities, and increased requirements for accreditation and supervision of notified...