EMA publishes Data Quality Framework for Real World Data
The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 has recently been updated. The revised Manual includes details concerning the classification of a number of products
MDCG Guidance on Breakthrough Devices under the MDR and the IVDR
The Medical Device Coordination Group (MDCG) has published its Guidance, MDCG 2025-9, on Breakthrough Devices within the Medical Devices Regulation (MDR) and the in vitro diagnostics Medical Devices Regulation (IVDR).
Neither the MDR nor the IVDR include a definition of what constitutes a Breakthrough Device. MDCG 2026-9, however,
MDCG Guidance on post-market surveillance of Medical Devices and In Vitro Diagnostic Medical Devices
In its last publication of 2025, MDCG 2025-10, the Medical Device Coordination Group (MDCG) provides guidance to manufacturers concerning the post-market surveillance (PMS) obligations imposed by the Medical Devices Regulation (MDR) and the in vitro diagnostics Medical Devices Regulation (IVDR) and the appropriate steps to ensure that these are fulfilled.
The Guidance recalls
MDGC Publishes Guidance on Performance Studies for IVDs
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 entered into force on 16 June 2024. The Regulations, which apply in Great Britain, introduce a new Part 4A to the existing Regulations governing post-market surveillance (PMS) requirements for medical devices. These include in vitro diagnostic (IVD) devices and active implantable medical devices.
Update to MDCG Guidance on Classification Rules for in vitro Diagnostic Medical Devices under in vitro diagnostics Regulation
An update to the MDCG Guidance on Classification Rules for in vitro Diagnostic Medical Devices under the in vitro diagnostics Regulation has been published.
New MHRA Guidance concerning extended periods of validity of CE Certificates and Declarations of Conformity for some in vitro diagnostic medical devices
Reflecting the 2024 revisions to the EU in vitro diagnostic Medical Devices Regulation, the UK MHRA has published a legislation extending acceptance of CE-marked in vitro diagnostic medical devices (IVDs) on the Great Britain (GB) market (Registration of certain in vitro diagnostic devices - GOV.UK).
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.