Tag: European Commission

Important Notice

EU AI Act approved by Parliament

July 3, 2023
Important Notice

Registering a legacy device in Eudamed is a good step

May 12, 2023
News in Brief

Proposed general product safety regulation is expected to entry into force shortly

May 2, 2023
News in Brief

UDI helpdesk website published

April 13, 2023
Important Notice

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

April 11, 2023
Important Notice

MDR extended transition timelines and removal of MDR and IVDR sell-off period adopted

March 20, 2023
News in Brief

News on guidance documents

March 3, 2023
Important Notice

European Commission proposal text accepted

March 1, 2023
News in Brief

Templates on hand for sponsors of IVD performance studies

February 15, 2023
News in Brief

New EU approach on cancer screening

February 15, 2023
News in Brief

Guidance document on in-house devices

February 15, 2023
Important Notice

European Commission proposal for extended transition timelines published

January 12, 2023
Important Notice

European Commission proposed MDR deadlines extension for legacy devices

December 14, 2022
News in Brief

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

October 11, 2022
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

Updated Blue Guide and MDR and IVDR harmonized standards

July 14, 2022
News in Brief

EU has to deal with discords between AI and medical device rules

July 1, 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
Important Notice, IVDR

IVD medical devices after the IVDR date of application

March 12, 2022
IVDR, News in Brief

EN ISO 13485 and symbols standards harmonised under the EU’s IVDR

February 27, 2022
MDR, News in Brief

MDR harmonised standards update

February 27, 2022
Important Notice, IVDR

IVDR clinical evidence

February 3, 2022
MDR, News in Brief

elFU rules under the EU‘s MDR

January 26, 2022
Important Notice, IVDR

European Commission proposal for progressive roll-out of the IVDR adopted

January 5, 2022
News in Brief

New artificial intelligence regulations could lead to unnecessary burdens

December 29, 2021
News in Brief

The MDR is now fully applicable – but it means not the end of the world

November 15, 2021
MDR, News in Brief

New guidance on legacy devices published

November 12, 2021
Important Notice, IVDR

Extended IVDR transition period for certain IVD medical devices

October 25, 2021
IVDR, MDR, News in Brief

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

October 4, 2021
IVDR, MDR, News in Brief

Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN

June 15, 2021