Tag: IVDR

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
Download Section, Library

Complete Download Section mdi Europa

July 21, 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
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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
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Manufacturers must act now to satisfy IVDR

December 4, 2023
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AI significant in October regulatory discussions

December 1, 2023
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EU rules for device software working with hardware

November 29, 2023
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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
Important Notice

EU AI Act approved by Parliament

July 3, 2023
News in Brief

Team-NB position papers on MDR and IVDR technical documentation

June 7, 2023
News in Brief

MDCG 2020-3 updated

June 5, 2023
News in Brief

Swiss Federal Council to mirror extended transition timelines for MDR legacy devices

June 2, 2023
Important Notice

Registering a legacy device in Eudamed is a good step

May 12, 2023
Important Notice

Q&A document published on the extended transition period for medical devices under the MDR

April 11, 2023