New MDCG 2024-10: Clinical Evaluation of Orphan Medical Devices
MDCG 2024-10 provides guidance on the clinical evaluation of orphan medical devices and highlights criteria for classification as such.
Trends in Biological Evaluations: New Draft Version of EN ISO 10993-1
The standard for the biological evaluation, EN ISO 10993-1, is currently under revision with several important amendments being proposed. Comments can now be submitted.
EC updates Guideline MDCG 2022-4
European Commission updates Guideline MDCG 2022-4 on appropriate surveillance of the transitional provisions regarding devices covered by certificates under the MMD and IVDD.
Amendment Proposal of MDR and IVDR: EU Parliament Approves Proposed Measures
The European Parliament approves the proposal for the gradual introduction of EUDAMED, the transitional arrangements for IVDs and obligation to report supply disruptions.
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.
