In this post, updating our series of posts on the implementation of the EU Medical Devices Regulation (MDR), we take a look at the latest steps taken by the EU institutions to ensure the MDR is fully applicable by May 2021. Despite the summer break and the difficulties caused by the pandemic, the Medical Device Coordination Group (MDCG) and the European Commission have endorsed a number of significant guidance documents relevant for manufacturers, national authorities,…

On 7 September 2020, the European Data Protection Board (EDPB) initiated a public consultation on draft Guidelines 07/2020 on the concepts of controller and processor in the GDPR. Any interested party could provide comments by 19 October 2020 using the dedicated form. The draft Guidelines contain elements that are of interest for companies active in the life science sector as they may have an impact on comapnies’ day-to-day research and commercial activities in the…

On 28 August 2020, the UK Department of Health & Social Care published a consultation on proposed changes to the Human Medicines Regulations 2012 (HMRs) to support the rollout of COVID-19 vaccines.…

Earlier this month, we commented on the European Commission proposal for a Regulation accelerating existing procedures for clinical trials where medicinal products containing or consisting of Genetically Modified Organisms (GMOs) are tested for the development of vaccines and therapies to treat COVID-19. The European Commission had proposed that, during the pandemic and by derogation to the GMO regulatory framework, the requirement of a prior environmental risk assessment or consent by the national competent authorities should not apply.…

Today, the Court of Justice of the European Union delivered a landmark judgement with significant practical impact for companies transferring personal data outside the European Economic Area to the United States. The Court of Justice confirmed the validity of the Standard Contractual Clauses for transfer of personal data between a controller in the EU and a processor in a third country (e.g., the US) adopted by the European Commission in Decision 2010/87/EU. The Court…

As part of the strategy to fight COVID-19, the European Commission has proposed a Regulation to facilitate the conduct of clinical trials using medicinal products containing or consisting of Genetically Modified Organisms (GMOs). The European Commission recognises that the applicable regulatory framework in relation to GMOs is unable to adequately address the challenges created by the pandemic. While some vaccines in development contain attenuated viruses or live vectors, which may fall within the definition of…

On 11 June 2020, the European Medicines Agency (EMA), during its Management Board meeting, has endorsed the methodology and next steps leading to the go-live of the Clinical Trials Information System (CTIS) which is now fixed for December 2021. A group consisting of representatives of the EU Member States and the European Commission has been set up to prioritise and coordinate all outstanding issues prior to go-live. The CTIS is the centralised EU portal…