Launching EU Dashboard Monitoring the Availability of Medical Devices and In Vitro Diagnostic Medical Devices
European Commission launches a dashboard monitoring the availability of MD and IVDR
MDCG 2021-27, Revision 1, Guidance for Articles 13 (Importers) & 14 (Distributors)
MDCG 2021-27 guidance on the obligations of medical device importers and distributors has been revised.
MDCG 2019-07 Guidance on Article 15 on the PRRC revised
Guideline MDCG 2019-07 on the tasks and responsibilities of the PRRC has been revised.
Team-NB: Position paper on medical device lifetime
Team-NB published a position paper on the lifetime of medical devices on 15 December 2023
Commission Implementing Regulation 2023/2713 published
2023/27 designating EU reference laboratories in the field of IVD MD
MDCG 2022-11 revised in November 2023
Notice to manufacturers to ensure timely compliance with MDR requirements
SCC team at MEDICA-COMPAMED 2023
Thank you for joining us at MEDICA-COMPAMED 2023
MDCG 2023-4 Guidance for Medical Device Software (MDSW) – Hardware combinations published
MDCG 2023-4 guidance was published on 18 October 2023
New ISO 10993-17:2023 available defining the toxicological risk assessment of medical device constituents
New ISO 10993-17:2023 available defining the toxicological risk assessment of medical device constituents 22 September 2023 The new ISO 10991-17:2023 (Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents) has been published. After more than 20 years, the standard replaces the previous version from 2002, introducing a lot of […]
US-FDA publishes a revised guidance “Use of International Standard ISO 10993-1”
On September 8, the FDA published an update of the document “Use of International Standard ISO 10993-1”, adapting it to the newest ISO 10993-1:2018.
