Article originally published in the FDLI Update (January/February 2013)

“Being able to use innovative products at the earliest possible time – and in Europe we deliver innovation about three years before our American counterparts with their own system – is a benefit to patients that we cannot put aside.” This is how former European Union (EU) Commissioner for Health John Dalli expressed his views on the upcoming medical device regulation in a speech held in June 2012 before the European Parliament (EP).

These strong words in favor of innovation were necessary to balance the emotion caused in the EU by the recent breast implants and metal-on-metal hip joint replacements scandals and the subsequent EP resolution calling for safer medical devices and the introduction of a marketing authorization system for high-risk devices.

This article will analyze the main changes to the current regulatory framework for medical devices in the EU recently proposed by the EU Commission. hese changes are currently being reviewed by the EP and the Council, the institution representing the 27 Member States of the EU. For U.S. companies that have — or hope to have — products on the EU market, it will be critical to monitor this process as the EP and Council consider the Commission’s proposal. Given that this process will unfold over at least one year, there will be numerous opportunities for companies to make their voices heard on aspects of the new regulatory system.

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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he presents numerous innovative life sciences companies, including start-ups, as well as several industry associations.