EU Medical Devices – Borderline Manual Under EU MDR and IVDR – Updated Version The European Commission has published an updated version of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. EU Medical Devices – Borderline Manual Under EU MDR and IVDR – Updated Version
EU Medical Devices – Updated Schedule for 2025 MDCG and Subgroup Meetings The European Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2025. EU Medical Devices – Updated Schedule for 2025 MDCG and Subgroup Meetings
MHRA Medical Devices: Standardised Format for PMSR MHRA has published guidance on 'medical devices: standardised format for the post market surveillance report' with the intention to provide information and recommendations for manufacturers on the preparation and presentation of a post market surveillance report (PMSR). MHRA Medical Devices: Standardised Format for PMSR
MHRA Publishes Updated Government Response to the Consultation on Statutory Fees for Medical Devices MHRA has now published an update to the Government Response to the MHRA Consultation on Statutory Fees setting out the final proposals for introducing a new annual fee to fund post-market surveillance of medical devices. MHRA Publishes Updated Government Response to the Consultation on Statutory Fees for Medical Devices
MHRA Survey: Designated Standards Prioritisation MHRA has launched a survey to seek input on the prioritisation for designation of important device standards that support compliance with MDR 2002 to help inform the ongoing prioritisation process for device standards designated. MHRA Survey: Designated Standards Prioritisation
EMA ICH Consultation – Q3E Draft Guideline for Extractables and Leachables & Supporting Documentation The European Medicines Agency (EMA) has published for public consultation the draft International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3E Guideline for extractables and leachables and ICH Q3E Guideline for extractables and leachables - supporting documentation: class 3 leachable monographs. EMA ICH Consultation – Q3E Draft Guideline for Extractables and Leachables & Supporting Documentation
EUDAMED Workshops The European Commission is organising two more free hybrid workshops on the European database on medical devices (EUDAMED). The primary goal of the workshops is to help stakeholders understand what the mandatory use of EUDAMED will mean and raise awareness on the timelines for its use. EUDAMED Workshops
Exclusive Webinar – Understanding the Life Sciences Innovative Manufacturing Fund (LSIMF) The OLS and PAGB are hosting a special webinar, exclusive to PAGB members, marking one year since the launch of the Life Sciences Innovative Manufacturing Fund (LSIMF) Exclusive Webinar – Understanding the Life Sciences Innovative Manufacturing Fund (LSIMF)
DHSC – Industry Placements The Department of Health and Social Care (DHSC) has run over 30 placements with more than 150 DHSC colleagues since last year. DHSC is now looking to secure new placements. DHSC – Industry Placements
MedTech Webinar – Part IX of the Drug Tariff The Department of Health and Social Care (DHSC) MedTech team is hosting a webinar covering the launch of the enhanced assessment process for Part IX of the Drug Tariff MedTech Webinar – Part IX of the Drug Tariff
EU Medical Devices – Updated Schedule for 2025 MDCG and Subgroup Meetings Released The European Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2025. EU Medical Devices – Updated Schedule for 2025 MDCG and Subgroup Meetings Released
Summer 2025 MedRegs Blog Published MHRA has published the summer 2025 edition of the MedRegs blog. In this post, Rob Reid highlights recent regulatory developments such as reliance pathways, the upcoming CE mark consultation, and early access routes. Summer 2025 MedRegs Blog Published
