Borderlines with Medical Devices and Other Products in Great Britain Guidance MHRA has made minor updates to the Borderlines with Medical Devices and Other Products in Great Britain guidance. Borderlines with Medical Devices and Other Products in Great Britain Guidance
45th Notified Body Designated Under EU MDR Denmark-based Notified Body ‘TÜV SÜD Danmark’ has been notified as the 45th Notified Body under the EU MDR. 45th Notified Body Designated Under EU MDR
Upcoming Stakeholder Workshop: EY Study on Medical Device Regulatory Governance and Innovation EY stakeholder workshop on medical device regulatory governance. Register by April 19 for in-person participation. Upcoming Stakeholder Workshop: EY Study on Medical Device Regulatory Governance and Innovation
MHRA MedTech Regulatory Reform Webinar Recording Watch the MHRA MedTech Regulatory Reform Webinar, providing key updates for the future medical device framework. MHRA MedTech Regulatory Reform Webinar Recording
Commission Releases Annual Overview of Medical Device Consultation Procedures Commission's annual overview of medical device consultation procedures per MDR Article 54(4). Commission Releases Annual Overview of Medical Device Consultation Procedures
MHRA Newsletter Published – March 2024 The MHRA has published the latest edition of its industry newsletter. MHRA Newsletter Published – March 2024
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
