MDCG 2022-5 Rev.1: Updated guidance on borderline products
Revised MDCG 2022-5 Rev.1 aims to improve classification of borderline products with new examples and explanations.
MDCG 2024-13: Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices
MDCG 2024-13: EtO is subject to the MDR/IVDR, although EtO as a substance does not require additional conformity assessment.
TEAM NB press release on transition to the implementation of Class D IVDs oversight by EU reference laboratories
Class D in vitro diagnostic medical devices must be tested by an EU reference laboratory laboratories designated by the European Commission
MDCG 2021-25 Rev. 1: MDCG publishes revised guidance on the application of MDR requirements to legacy devices
MDCG revises its guidance on the application of MDR requirements to legacy devices
MDCG 2024-12 Rev. 1: MDCG revises its guidance on CAPA plan assessment
MDCG revises its guidance on corrective and preventive action plan assessment, including templates
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.
