MDCG 2021-4 Rev. 1: How to apply transitional provisions for certification of class D IVD
MDCG releases Revision 1 of the MDCG 2021-4 document
Corporate News – SCC Joins Forces with Ramboll
We are pleased to announce to have joined Ramboll, the global engineering, architecture and consultancy company
New BMBF funding guideline for “clinical validation of innovative medical technology solutions” in Germany
Germany issues a new guideline on funding for clinical validation of innovative medical technology solutions
Go Live for the Swiss Medical Devices Database ‘Swissdamed’
On 6 Agust, Switzerland launches the 1st module of swissdamed.
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.
