Team-NB Revises its Position Paper on Transfer Agreement for Surveillance of ‘Legacy Devices’
On 2 July, Team-NB publishes a revised paper on transfer agreement for serveillance of legacy devices.
New Regulation (EU) 2024/1689 harmonising rules on artificial intelligence
New Regulation (EU) 2024/1689 harmonising rules on artificial intelligence published on 12 July 2024
New Regulation (EU) 2024/1860 amending the Regulation (EU) 2017/745 and (EU) 2017/742
New Regulation (EU) 2024/1860 published on 9 July 2024 amending MDR and IVDR.
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.
