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
Important Changes to PAGB Regulatory Inboxes The PAGB food supplement inbox (foodsupplements@pagb.co.uk) has now been merged with the PAGB regulatory inbox (regulatory@pagb.co.uk). Important Changes to PAGB Regulatory Inboxes
Building an Integrated, Rules-based MedTech Pathway Event – 25 July 2024 An event for industry stakeholders, ‘Building an integrated, rules-based MedTech Pathway’, is taking place on 25 July 2024 between 13.30 – 15.00. Building an Integrated, Rules-based MedTech Pathway Event – 25 July 2024
