EU – MDCG Work in Progress – Ongoing Guidance Documents Guidance development and deliverables of MDCG Subgroups as of March 2024 has been published on the Commission website. EU – MDCG Work in Progress – Ongoing Guidance Documents
MDCG Guidance on Content of Clinical Investigation Plan for Clinical Investigations of Medical Devices Published The Medical Device Coordination Group (MDCG) has endorsed the guidance document on the content of the Clinical Investigation Plan for clinical investigations of medical devices (MDCG 2024-3). MDCG Guidance on Content of Clinical Investigation Plan for Clinical Investigations of Medical Devices Published
Notified Bodies Survey on Certifications & Applications Published The European Commission has published a revised version of the Notified Bodies Survey on certifications and applications. Notified Bodies Survey on Certifications & Applications Published
Independent Review into Equity in Medical Devices Published The Independent Review into Equity in Medical Devices has now been published, alongside the government’s response. Independent Review into Equity in Medical Devices Published
UK REACH: Rationale for priorities Defra, and the Scottish and Welsh Governments have set out a rationale for the UK REACH work programme UK REACH: Rationale for priorities
EU Harmonised Standards – Implementing Decisions Published in EU’s Official Journal Two Commission Implementing Decisions with new references of harmonised standards have been published in the Official Journal of the European Union (OJEU). EU Harmonised Standards – Implementing Decisions Published in EU’s Official Journal
44th Notified Body Designated Under EU MDR Swedish-based Notified Body ‘RISE Medical Notified Body AB’ has been notified as the 44th Notified Body under the EU MDR. 44th Notified Body Designated Under EU MDR
IDAP Data Protection and Privacy Information Data protection and privacy information have been added to MHRA's guidance page on the Innovative Devices Access Pathway (IDAP). IDAP Data Protection and Privacy Information
MHRA Chief Executive Dame June Raine to Step Down Dame June Raine, MHRA's Chief Executive, will be stepping down in the Autumn following 5 years in the role. MHRA Chief Executive Dame June Raine to Step Down
Ingredient Challenge – Silicon Dioxide (E 551) Potential ingredient challenge when using food additive E 551 in food supplements, medicines and medical devices. Ingredient Challenge – Silicon Dioxide (E 551)
Smarter Regulation: Regulating for Growth Consultation Response The government response to the consultation, 'Smarter Regulation: Regulating for Growth', was published on 21 February 2024. Smarter Regulation: Regulating for Growth Consultation Response
Commission Consultation on Evaluation of MDR Planned for 2024 The European Commission is planning a targeted evaluation of the MDR and IVDR in 2024, alongside a public consultation in Q3. Commission Consultation on Evaluation of MDR Planned for 2024
