Tag: Guidance Documents

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
News in Brief

EU guidelines for justifying phthalates in medical devices updated

July 26, 2024
Download Section, Library

Complete Download Section mdi Europa

July 21, 2024
News in Brief

European Commission guidance publication update

July 12, 2024
News in Brief

European Commission publication update

May 3, 2024
News in Brief

MDCG published guidance on EMDN code updates and clinical investigation plans

March 13, 2024
News in Brief

MDCG published device specific vigilance guidance

February 8, 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

EU rules for device software working with hardware

November 29, 2023
News in Brief

European Commission publications update

November 15, 2023
News in Brief

European Commission publishes third revision of the borderline manual

October 10, 2023
Important Notice

Advice on how to satisfy EU requirements for MDR legacy devices

October 6, 2023
Important Notice

Update on Regulation (EU) 2023/607 – extended MDR transition period

September 12, 2023
Important Notice

A closer look at MDCG 2023-3 on vigilance

August 11, 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

News on guidance documents

March 3, 2023
News in Brief

Templates on hand for sponsors of IVD performance studies

February 15, 2023
News in Brief

Guidance document on in-house devices

February 15, 2023
IVDR, MDR, News in Brief

EU guidance on authorised representatives

January 11, 2023
Important Notice

EU’s Implementing Regulation on Common Specifications for class D IVDs

September 6, 2022
Important Notice

Different options for IVD medical devices until Eudamed becomes fully operational

September 2, 2022
Important Notice, IVDR, MDR

New MDCG guidance documents under the MDR and IVDR

June 7, 2022
Important Notice, MDR

New guidance on borderline products between drugs and medical devices under the MDR

June 1, 2022
Important Notice, IVDR

MDCG publishes guidance on significant changes for legacy products under the IVDR

May 11, 2022
IVDR, News in Brief

New guidance for notified bodies of MDD/ AIMDD legacy device certificates and IVDR class D devices

March 4, 2022
COVID-19, News in Brief

New guidance for third-country manufacturers of COVID-19 IVD tests

February 6, 2022
Important Notice, IVDR

IVDR clinical evidence

February 3, 2022
IVDR, MDR, News in Brief

MDCG guidance document on distributors and importers published

December 12, 2021
MDR, News in Brief

New guidance on legacy devices published

November 12, 2021
Important Notice, MDR

New European Commission guidance document on MDR medical device classification

October 11, 2021