Tag: MDCG

News in Brief

Additional updates from the European Commission

December 9, 2024
Important Notice

MDCG Q&A document on vigilance updated

December 2, 2024
News in Brief

New and updated MDCG guidance

November 8, 2024
News in Brief

MDCG 2021-4 has been updated with revision 1

October 28, 2024
News in Brief

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

August 14, 2024
News in Brief

European Commission guidance publication update

July 12, 2024
News in Brief

Update of MDCG 2022-4

June 10, 2024
News in Brief

Could the AI Act result in the limited availability of medical technologies?

April 21, 2024
News in Brief

MDCG published guidance on EMDN code updates and clinical investigation plans

March 13, 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
Important Notice

A closer look at MDCG 2023-3 on vigilance

August 11, 2023
News in Brief

News on guidance documents

March 3, 2023
IVDR, MDR, News in Brief

EU guidance on authorised representatives

January 11, 2023
News in Brief

News on useful publications: MDCG borderline manual and bsi white paper on performance evaluations

October 13, 2022
News in Brief

Criticism on the EU’s 19-Point Regulatory Action Plan

October 11, 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
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
COVID-19

SARS-CoV-2 IVD tests and the IVDR

October 7, 2021
IVDR, MDR, News in Brief

MDCG 2019-6, rev. 3 lays out provisions for notified body pre-certification services

October 4, 2021
COVID-19, News in Brief

The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD

August 5, 2021
Important Notice, IVDR

IVD or not IVD? That is the question…

April 15, 2021
Important Notice

Key guidance document on the classification of IVDs under the IVDR

December 1, 2020
Important Notice, MDR

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 2020
IVDR, MDR, News in Brief

Get ready for the economic operator registration in EUDAMED

October 9, 2020