Category: CE Consulting

CE Consulting, Partners

The Regulatory Affairs Network That Keeps Your Business Safe

August 3, 2023
CE Marking, Important Notice

The UK and Switzerland need special attention

June 8, 2023
CE Marking, IVDR, News in Brief

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

June 8, 2023
IVDR, MDR, News in Brief

EU guidance on authorised representatives

January 11, 2023
Important Notice, IVDR, MDR

Updated Blue Guide and MDR and IVDR harmonized standards

July 14, 2022
MDR, News in Brief

CAMD working group publishes Q&A document regarding FSCs

July 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
Important Notice, IVDR

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

May 11, 2022
Important Notice, IVDR, MDR

EUDAMED update on timelines

April 10, 2022
Important Notice, IVDR

IVD medical devices after the IVDR date of application

March 12, 2022
IVDR, News in Brief

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

March 4, 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
MDR, News in Brief

bsi white paper on clinical evaluations

December 15, 2021
IVDR, MDR, News in Brief

MDCG guidance document on distributors and importers published

December 12, 2021
Important Notice, IVDR, MDR

European Commission EUDAMED website expanded

December 6, 2021
MDR, News in Brief

New guidance on legacy devices published

November 12, 2021
IVDR, MDR, News in Brief

IEC about to publish new standard on cybersecurity

November 10, 2021
Important Notice, IVDR

Extended IVDR transition period for certain IVD medical devices

October 25, 2021
IVDR, MDR, News in Brief, Partners

Free intended use generator – an important tool under the MDR and IVDR

October 15, 2021
Important Notice, MDR

New European Commission guidance document on MDR medical device classification

October 11, 2021
Important Notice, IVDR, MDR

EUDAMED UDI/Devices and NBs/Certificates modules now live

October 6, 2021
IVDR, MDR, News in Brief

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

October 4, 2021
MDR, News in Brief

bsi article on clinical evaluation requirements under the MDR

August 8, 2021
MDR, News in Brief

Team-NB publishes position paper on the applicability of MDR implant card requirements

August 1, 2021
IVDR, MDR, News in Brief

New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR

July 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
IVDR, MDR, News in Brief

EU UDI helpdesk available

June 10, 2021
IVDR, MDR, News in Brief

Standard ISO 20417:2021 for the MDR and IVDR published

June 3, 2021