MHRA Announces Dedicated New Team to Support the International Community in Tackling Antimicrobial Resistance MHRA's specialized team to support the international community combat the growing threat of antimicrobial resistance (AMR). MHRA Announces Dedicated New Team to Support the International Community in Tackling Antimicrobial Resistance
49th Notified Body Designated Under the EU MDR Austria-based Notified Body ‘QMD Services GmbH’ has been notified as the 49th Notified Body under the MDR. 49th Notified Body Designated Under the EU MDR
MHRA – Enforcing the Medical Devices Regulations MHRA has published an updated version of ‘Medical devices: the regulations and how we enforce them’ to reflect changes to the legislation relating to MHRA’s investigatory and enforcement powers. MHRA – Enforcing the Medical Devices Regulations
BIVDA Webinar – An Introduction to the Procurement Act 2023 MHRA has published the recording of the webinar on the established medicines licensing process, which took place in April 2024. BIVDA Webinar – An Introduction to the Procurement Act 2023
Preliminary Assessment Review (PAR) and Preliminary Re-assessment Review (PRAR) Form Template for EU MDR and IVDR published Several MDCG guidance documents have been published on the Commission website (MDCG 2024-6, MDCG 2024-7, MDCG 2024-8, MDCG 2024-9). These concern the Preliminary assessment review (PAR) and Preliminary re-assessment review (PRAR) form templates for the EU MDR and IVDR. Preliminary Assessment Review (PAR) and Preliminary Re-assessment Review (PRAR) Form Template for EU MDR and IVDR published
48th Notified Body Designated Under the EU MDR Türkiye-based Notified Body ‘Kiwa Belgelendirme Hizmetleri A.Ş.’ has been notified as the 48th Notified Body under the MDR 48th Notified Body Designated Under the EU MDR
MHRA AI Airlock Launched MHRA has launched AI Airlock, a regulatory sandbox for AI as a Medical Device (AIaMD) to address challenges for regulating devices using AI. MHRA AI Airlock Launched
47th Notified Body Designated Under the EU MDR Italy-based Notified Body ‘MTIC InterCert S.r.l.’ has been notified as the 47th Notified Body under the MDR. 47th Notified Body Designated Under the EU MDR
MHRA AI Strategy Paper Published MHRA has published its strategic approach to AI, setting out how MHRA approaches AI as a regulator of AI products. MHRA AI Strategy Paper Published
Notify MHRA About a Clinical Investigation for a Medical Device – Guidance for Manufacturers Updated MHRA has updated the guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices to update the guidance for manufacturers. Notify MHRA About a Clinical Investigation for a Medical Device – Guidance for Manufacturers Updated
EUDAMED Information Centre Survey The Commission has added a new tab on the EUDAMED Playground Information Centre landing page: ‘Give us your feedback’, as part of work to improve the EUDAMED Information Centre. EUDAMED Information Centre Survey
Notify the MHRA About a Clinical Investigation for a Medical Device – Guidance Updated MHRA has updated their guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices Notify the MHRA About a Clinical Investigation for a Medical Device – Guidance Updated
