Article originally published in European Pharmaceutical Contractor, September  2012

Although at first sight the rules that govern the distinction between medical devices and medicines in the EU allow for a direct and systematic approach, borderline determinations are, in practice, often difficult and the rules lack logical rigour

The European Commission is expected to publish proposals for a new EU legislation on medical devices later this year and the proposals may, for the first time, include a formal and systematic EU decision-making process for borderline determinations. However, these determinations will have to be made on the basis of the available legislation and interpretation principles, and it will be important to ensure that these are also clarified.

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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.

Photo of Sarah Cowlishaw Sarah Cowlishaw

Sarah Cowlishaw’s practice focuses on life sciences regulatory and commercial law for pharmaceutical, medical device, food, and consumer products. Her advice on general regulatory matters includes borderline determinations, food classifications, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion. Ms.

Sarah Cowlishaw’s practice focuses on life sciences regulatory and commercial law for pharmaceutical, medical device, food, and consumer products. Her advice on general regulatory matters includes borderline determinations, food classifications, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion. Ms. Cowlishaw also advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.