Life Sciences weekly highlights—7 December 2023

Article summary

This week's edition of Life Sciences weekly highlights includes news that the Medical Device Coordination Group (MDCG) has published a revised position paper on notice to manufacturers and Notified Bodies (NBs) to ensure timely compliance with the MDR and IVDR requirements, the Council of the EU has agreed its position on the proposed regulation for a European Health Data Space (EHDS) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) has responded to the position expressing its concerns about the inclusion of opt-out and opt-in mechanisms for certain categories of data. Also included is news that the DHSC has published new terms for the Statutory Scheme for branded medicines and the Heads of Medicines Agencies (HMA) and the EMA have published a joint report on their response to the public health emergency caused by the coronavirus (COVID-19) pandemic.