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.
France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by a national regulator … Continue Reading
The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU … Continue Reading
The UK National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending tightening standards for hip replacement devices. If adopted, the tougher standards could force the National Health Service (NHS) to stop using a significant number of existing devices, with obvious impacts on manufacturers of these products.… Continue Reading
On May 30, 2013, Advocate General Sharpston delivered an opinion on a request for a preliminary ruling from the Finnish national courts concerning the laws governing reclassification of medical devices (Advocate General: Opinion, Case C-109/12). The Advocate General’s opinion does not bind the Court of Justice of the European Union (CJEU). However, in the majority of … Continue Reading
Commission Regulation (EU) 207/2012 on electronic instructions for use of medical devices (the Regulation) came into force in the EU last month. The Regulation allows manufacturers of certain types of medical devices and accessories to replace paper form instructions of use with an electronic substitute. It aims to reduce environmental burden and improve the competitiveness … Continue Reading