MEET us at MEDICA-COMPAMED 2024
Join SCC at MEDICA-COMPAMED in Düsseldorf on 11-14 November 2024
Update of MDCG 2020-16 Guidance on Classification Rules for IVDs under (EU) 2017/746
On 8 July 2024, MDCG published the 3rd revision of its guidance MDCG 2020-16 on classification rules for in vitro IVDs under (EC) 2017/746.
Update of MDCG 2021-5 Guidance on Standardisation of Medical Devices
On 2 July 2024, MDCG updated its guidance MDCG 2021-5 on various aspects of medical device standards.
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
