All general animal safety tests abolished
As part of its on-going process towards elimination of animal testing from its scope, the European Pharmacopoeia has removed all references to the previous general chapters on pyrogens, histamine and depressor substances.
Certain EU medical device laws will not be sunsetted in Great Britain on 26th May 2025
The plan to sunset a number of EU medical device laws in Great Britain has been revised following related consultation. It had been expected that four pieces of EU legislation; European Commission Decision 2002/364, on common technical specifications for in vitro diagnostic medical devices, Regulation 207/2012, on electronic instructions for use of medical devices.
Commission publishes Guidelines on the definition of an artificial intelligence system established by the AI Act
The European Commission has published Guidelines on the definition of an artificial intelligence system established by Regulation (EU) 2024/1689 (AI Act) file:///C:/Users/ewright/Work%20Folders/Downloads/Guidelines_on_the_definition_of_an_artificial_intelligence_system_established_by_AI_Act_VJp35Ve5WA4XFrpUSFj5ohfaBco_112455.pdf
Pilot system for sponsors of clinical investigations of medical devices
Sponsors of clinical investigations in the EU have been invited to apply to participate in a pilot scheme introducing a coordinated assessment of clinical investigations and performance studies as provided in Articles 78 of the Medical device Regulation and Article 74 of the in vitro diagnostic medical devices Regulation (https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en).
Q&A requirements related to notified bodies
The Medical Device Coordination Group (MDCG) has published an update to its Q&A related to notified bodies’ requirements under MDR and IVDR, MDCG 2019-6 Rev5. (https://health.ec.europa.eu/document/download/9c9c532f-013a-477c-9378-0a9e714e5549_en?filename=md_mdcg_qa_requirements_notified_bodies_en.pdf).
Belgian health technology assessment (HTA) body to lead consortium of EU Member State HTA bodies carrying out joint clinical assessments (JCA) under the HTA Regulation.
The Belgian health technology assessment (HTA) body, INAMI-RIZIV, will lead the consortium of EU Member State HTA bodies that will carry out joint clinical assessments under the HTA Regulation.
HTA Regulation Implementing Regulation concerning joint scientific consultations on medical devices and IVDs
The European Commission has published an implementing regulation for the Health Technology Assessment Regulation (HTA Regulation) concerning joint scientific consultations on medical devices and in vitro diagnostic devices https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500117.
EMA Updates and Strengthens Policy on Conflicts of Interest
The European Medicines Agency (EMA) has recently published an update to the Agency’s Policy on conflicts of interests of members of scientific committees and experts.
MDCG 2023-3 Q&A in Vigilance Terms and Concepts in the MDR and IVDR Updated
MDCG has published MDCG 2023-3 Rev.2 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746.