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
MDCG Standards Working Group – 13 June 2024 The European Commission has published the official minutes from the MDCG Standards Working Group that took place on 13 June 2024. MDCG Standards Working Group – 13 June 2024
Information Session on EU MDR/IVDR for International Regulators On 4 July 2024 the European Commission hosted an information session on EU MDR/IVDR for international regulators, the slides and recording from this event have been published. Information Session on EU MDR/IVDR for International Regulators
EMA-AESGP Bilateral – April 2024 – Highlights Published The European Medicines Agency (EMA) has published the highlights from the fifth EMA-AESGP bilateral meeting held on 29 April 2024. EMA-AESGP Bilateral – April 2024 – Highlights Published
Team NB Position Paper – Transfer Agreement for Surveillance of Legacy Devices – Version 2 Team NB has published an updated version of its position paper on the transfer agreement for surveillance of legacy devices. Team NB Position Paper – Transfer Agreement for Surveillance of Legacy Devices – Version 2
Commission MDR/IVDR Virtual Information Session The European Commission will host a virtual information session to present the current status of the targeted evaluation of MDR/IVDR on Thursday, 12 September 2024. Commission MDR/IVDR Virtual Information Session
MDCG 2021-5 Rev.1 – July 2024 Guidance on Standardisation for Medical Devices The Medical Device Coordination Group (MDCG) has endorsed the newly revised version of MDCG 2021-5 Guidance on standardisation for medical devices. MDCG 2021-5 Rev.1 – July 2024 Guidance on Standardisation for Medical Devices
