Tag: IVDR

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January 19, 2025
Important Notice

Have your say!!!

January 12, 2025
News in Brief

Implementing regulations on eIFU, well-established technologies and orphan/ pediatric devices in sight

January 11, 2025
News in Brief

Guidance updates from the European Commission and TEAM-NB

January 7, 2025
News in Brief

Medical technology industry calls for urgent EU action

December 18, 2024
News in Brief

Additional updates from the European Commission

December 9, 2024
Important Notice

MDCG Q&A document on vigilance updated

December 2, 2024
Important Notice

Q&A document on the gradual rollout of EUDAMED available

November 30, 2024
News in Brief

Council of the European Union proposes key elements for MDR/ IVDR reform

November 29, 2024
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