Brian Kelly

Brian Kelly

Associate

Brian Kelly’s practice focuses on food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law and product liability and safety. Mr. Kelly’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice.

Subscribe to all posts by Brian Kelly

EU Updates MEDDEV 2.1/6 Guidance on Standalone Software

On 15 July 2016, the European Commission updated MEDDEV 2.1/6 (the “MEDDEV Guidance), its medical device guidance on the qualification and classification of stand alone software used in the healthcare setting. The updated version replaces an earlier version of MEDDEV 2.1/6 issued by the European Commission in January 2012. MEDDEV 2.1/6 generally stands as a … Continue Reading
LexBlog