Medical Device Legal News with Sam Bernstein: Episode 11
On April 14 2025, the European Data Protection Board (EDPB) announced the outcomes of its plenary session that took place on April 8 2025, during which the EDPB adopted draft Guidelines on processing of personal data through...more
This newsletter is a summary of the antitrust developments we think are most interesting to your business. James Webber (partner based in London) and Jess Bowring (counsel based in London) are our editors this month. They...more
Article 5(3) of the EU ePrivacy Directive (ePD) requires consent for tracking cookies (unless exceptions apply). Although this rule is best known as the reason behind ‘cookie’ banners, it is technology neutral and applies to...more
On 17 October 2023, the European Securities and Markets Authority (ESMA) published a statement (the Statement) clarifying the timeline for implementation of the Regulation on Markets in Cryptoassets ((EU) 2023/1114) (MiCA)...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The European Commission announced on 22 January 2020 that it is looking for feedback on draft guidelines on the implementation of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 (the "Regulation"). ...more
On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more
The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of different grades of water in the...more
On 22 November 2018, HM Treasury published Explanatory Information on the draft Financial Services and Markets Act 2000 (Amendment) (EU Exit) Regulations 2019 (the “Draft FSMA Regulations“)....more
The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft guidelines (the “Guidelines”) governing good clinical practice specific to advanced...more