MHRA, FDA and Health Canada Identify Five Guiding Principles for Predetermined Change Control Plans MHRA, FDA and Health Canada Identify Five Guiding Principles for Predetermined Change Control Plans The Medicines and Healthcare products Regulatory... MHRA, FDA and Health Canada Identify Five Guiding Principles for Predetermined Change Control Plans
Assignment of UDI for Contact Lenses – Delegated Regulation Published Assignment of UDI for Contact Lenses – Delegated Regulation Published The delegated regulation amending the EU MDR as regards the... Assignment of UDI for Contact Lenses – Delegated Regulation Published
MDCG 2023-4 Medical Device Software Hardware Combinations Guidance Published MDCG 2023-4 Medical Device Software Hardware Combinations Guidance Published The Commission has published a new document: MDCG 2023-4... MDCG 2023-4 Medical Device Software Hardware Combinations Guidance Published
EUDAMED Vigilance Working Group Meeting on 19 October 2023 EUDAMED Vigilance Working Group Meeting on 19 October 2023 The next MDCG EUDAMED Vigilance WG Meeting is taking place on... EUDAMED Vigilance Working Group Meeting on 19 October 2023
24th IMDRF Session 24th IMDRF Session The 24th International Medical Device Regulators Forum (IMDRF) session took place in Berlin, Germany during the last... 24th IMDRF Session
UKNI Mark and CE Mark Guidance Pages Updated UKNI Mark and CE Mark Guidance Pages Updated MHRA has updated the ‘Using the UKNI marking‘ and... UKNI Mark and CE Mark Guidance Pages Updated
MHRA Board Meeting Recording – 19 September 2023 MHRA Board Meeting Recording – 19 September 2023 The recording and board meeting pack of the MHRA Board Meeting... MHRA Board Meeting Recording – 19 September 2023
DHSC IDAP Webinar DHSC IDAP Webinar The Innovative Devices Access Pathway (IDAP) pilot, a program designed to accelerate the development of cost-effective medical... DHSC IDAP Webinar
EU MDR Implementation – Q&A Document on Transitional Provisions for Annex XVI Products Published EU MDR Implementation – Q&A Document on Transitional Provisions for Annex XVI Products Published The Commission has published the Q&A... EU MDR Implementation – Q&A Document on Transitional Provisions for Annex XVI Products Published
Microplastics – Publication of Commission Regulation 2023/2055 in OJEU Microplastics – Publication of Commission Regulation 2023/2055 in OJEU The Commission Regulation (EU) 2023/2055 of 25 September 2023... Microplastics – Publication of Commission Regulation 2023/2055 in OJEU
EUDAMED – Production Release 2.12 EUDAMED – Production Release 2.12 EUDAMED is the IT system developed by the European Commission to implement Regulation... EUDAMED – Production Release 2.12
MedTech Europe – Open Letter to Health Commissioner on Structural Reforms of Regulatory Frameworks MedTech Europe – Open Letter to Health Commissioner on Structural Reforms of Regulatory Frameworks MedTech Europe together with 34 of... MedTech Europe – Open Letter to Health Commissioner on Structural Reforms of Regulatory Frameworks
