MHRA Clinical Investigation for Medical Devices – QSR Template MHRA has added a new Quarterly Summary Reports (QSR) template to the guidance 'Notify MHRA about a clinical investigation for a medical device'. MHRA Clinical Investigation for Medical Devices – QSR Template
BHMA – Meet the BAPP Best Practices SOP Webinar BHMA in collaboration with ABC, AHP and NCNPR are hosting a webinar introducing the BAPP Best practices SOP on Tuesday 1 October at 4pm. BHMA – Meet the BAPP Best Practices SOP Webinar
MHRA AI Airlock – Webinar Recording Available In July, MHRA hosted a webinar on AI Airlock. The recording of this webinar has been published. MHRA AI Airlock – Webinar Recording Available
Defra- Extended Producer Responsibility (EPR) Fees Webinar Defra is hosting a webinar on EPR Fees. Defra- Extended Producer Responsibility (EPR) Fees Webinar
MHRA – Invoicing System Issue MHRA has discovered there is currently an IT issue which is causing the issuing of incorrect invoices. MHRA – Invoicing System Issue
Notify MHRA about a Clinical Investigation for a Medical Device – Regulatory Advice Meetings MHRA has updated the guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices to add a section on regulatory advice meetings. Notify MHRA about a Clinical Investigation for a Medical Device – Regulatory Advice Meetings
MHRA Medical Devices Registration System Updates MHRA has updated the Account Management Reference Guide, Device Registration Reference Guide and Certificates of Free Sale for Medical Devices guidance to reflect changes to the registration system. MHRA Medical Devices Registration System Updates
UK Environmental Improvement Plan The UK Government has publishes the Environmental Improvement Plan (EIP) Annual Progress Report. UK Environmental Improvement Plan
EU MDR/IVDR Implementation – Hyperlinks to Published Fees on Notified Bodies Websites The European Commission has updated its Notified Bodies for Medical Devices webpage. EU MDR/IVDR Implementation – Hyperlinks to Published Fees on Notified Bodies Websites
MHRA May and July Board Meeting Documents The agenda and board papers from the MHRA board meeting on 21 May and 9 July 2024 have been made available. MHRA May and July Board Meeting Documents
EU Competent Authorities Consensus Statement on the EU Medical Device Framework Competent Authorities for medical devices have endorsed a consensus statement on the status of the EU regulatory framework for medical devices. EU Competent Authorities Consensus Statement on the EU Medical Device Framework
Status Ethylene Oxide used for Sterilization of MDs – MDCG Draft Position The European Commission has launched a stakeholder consultation on the MDCG draft position regarding the regulatory status of ethylene oxide intended for the sterilization of medical devices. Status Ethylene Oxide used for Sterilization of MDs – MDCG Draft Position
