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.