Harmonised Standards under EU MDR / IVDR: EC Publishes New Implementing Decisions (EU) 2021/1182 and (EU) 2024/817
On 8 March 2024, the EC published new implementing decisions further amending harmonised standards under EU MDR and EU IVDR.
MDCG 2024-1-(1-4) Guidance on the vigilance system for CE-marked devices (DSVG 01-04)
MDCG has recently published five new documents concerning Device Specific Vigilance Guidance (DSVG)
European Commission Issues Language Requirements for Medical Device Manufacturers
On 17th January 2024, the European Commission published the overview of language requirements for the product information and instructions
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
