Tag: IVDR

News in Brief

New expert panel review in the context of the PECP

November 28, 2024
Important Notice

Q&A on obligation to inform in case of interruption/ discontinuation of supply chain published

November 12, 2024
News in Brief

New and updated MDCG guidance

November 8, 2024
News in Brief

Team NB has been updated its Code of Conduct

November 1, 2024
News in Brief

MDCG 2021-4 has been updated with revision 1

October 28, 2024
News in Brief

EU on proposed regulations for seven high-risk IVD test categories

October 2, 2024
News in Brief

TEAM-NB position paper on IVDR transfer agreement for surveillance

September 26, 2024
News in Brief

The EU’s standardisation guidance MDCG 2021-5 has been updated

August 14, 2024
Important Notice

Draft manufacturer self-declaration and notified body confirmation letter for Regulation (EU) 2024/1860 available

August 9, 2024
Important Notice

When is a medical device impacted by the AI Act?

August 6, 2024
News in Brief

European Commission guidance publication update

July 12, 2024
Important Notice

Amending Regulation (EU) 2024/1860 published in the OJEU

July 10, 2024
News in Brief

BSI first notified body to officially publish lead times under EU Medical Devices Regulations

June 14, 2024
Important Notice

Extension of IVDR transition periods and early launch of Eudamed takes last hurdle

May 31, 2024
News in Brief

European Commission publication update

May 3, 2024
Important Notice

Extension of IVDR transition periods and early launch of Eudamed about to be finally adopted

April 26, 2024
News in Brief

MDCG published guidance on EMDN code updates and clinical investigation plans

March 13, 2024
News in Brief

Revised product liability directive

March 9, 2024
Important Notice

Language requirements overview for the Union market

February 14, 2024
Important Notice

Extension of IVDR transition periods and early launch of Eudamed in the pipeline

February 7, 2024
Important Notice

EU’s first reference laboratories for high-risk Class D IVDs

January 14, 2024
News in Brief

Update to MDCG 2021-27 on importer and distributor roles

January 12, 2024
News in Brief

European Commission publications update on clinical investigations and annex XVI products

January 11, 2024
News in Brief

Manufacturers must act now to satisfy IVDR

December 4, 2023
News in Brief

AI significant in October regulatory discussions

December 1, 2023
News in Brief

EU rules for device software working with hardware

November 29, 2023
News in Brief

European Commission publications update

November 15, 2023
Important Notice

EU medical device industry faces further delays related to EUDAMED

November 7, 2023
News in Brief

Is a centralised governance agency for medical devices feasible?

November 1, 2023
News in Brief

European Commission publishes third revision of the borderline manual

October 10, 2023
News in Brief

Harmonization of MDR and IVDR standards still slow

August 14, 2023
News in Brief

Cybersecurity expertise shortage in EU

August 7, 2023
Library, Supportive Information

Supportive Information Section mdi Europa

August 1, 2023