MHRA Board Meeting – 15 November 2022 MHRA (Medicines and Healthcare products Regulatory Agency) Board Meeting – 15 November 2022 The MHRA Board will meet in public... MHRA Board Meeting – 15 November 2022
MDCG Guidance on Authorised Representatives Published MDCG Guidance on Authorised Representatives Published The Commission has published on its website the final Medical Device Coordination Group (MDCG)... MDCG Guidance on Authorised Representatives Published
MHRA Delivery Plan 2021-2023 – Updates for Year Two MHRA Delivery Plan 2021-2023 – Updates for Year Two The Delivery Plan 2021-2023 ‘Putting patients first; A... MHRA Delivery Plan 2021-2023 – Updates for Year Two
MHRA September Board Meeting Documents MHRA September Board Meeting Documents The agenda and board papers from the MHRA board meeting on 20... MHRA September Board Meeting Documents
MDCG Q&A Requirements Relating to Notified Bodies – Updated MDCG Q&A Requirements Relating to Notified Bodies – Updated An updated version (version 4) of the MDCG ‘Questions and answers:... MDCG Q&A Requirements Relating to Notified Bodies – Updated
EU Commission Updates the Rolling Plan Containing List of Essential Implementing Acts for the EU MDR European Commission Updates Rolling Plan The European Commission has updated the Rolling Plan (as of October 2022)... EU Commission Updates the Rolling Plan Containing List of Essential Implementing Acts for the EU MDR
MHRA Letter Regarding Updated Timelines for Implementing Future Medical Devices Regulations MHRA Letter Regarding Updated Timelines for Implementing Future Medical Devices Regulations MHRA has shared a letter from... MHRA Letter Regarding Updated Timelines for Implementing Future Medical Devices Regulations
MHRA Software and AI as a Medical Device Change Programme – Roadmap Updated MHRA Software and AI as a Medical Device Change Programme – Roadmap Updated MHRA has embarked upon a programme of... MHRA Software and AI as a Medical Device Change Programme – Roadmap Updated
EMA Workshop on Patient Experience Data in Medicines Development and Regulatory Decision-making EMA Workshop on Patient Experience Data in Medicines Development and Regulatory Decision-making The European Medicines Agency (EMA) has... EMA Workshop on Patient Experience Data in Medicines Development and Regulatory Decision-making
MHRA MORE Registrations – User Reference Guide Published MHRA MORE Registrations – User Reference Guide Published MHRA has published a step-by-step guide on using the Manufacturer’s On-line Reporting Environment... MHRA MORE Registrations – User Reference Guide Published
HMA 109th Meeting Highlights – September 2022 HMA 109th Meeting Highlights – September 2022 The Heads of Medicines Agencies (HMA) have published the highlights... HMA 109th Meeting Highlights – September 2022
34th Notified Body has been designated under the EU MDR Italy-based notified body ‘ENTE CERTIFICAZIONE MACCHINE SRL’ has been notified as the 34th Notified Body under the EU MDR. The... 34th Notified Body has been designated under the EU MDR
