Category: MDR

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, MDR

EUDAMED update on timelines

April 10, 2022
MDR, News in Brief

MDR harmonised standards update

February 27, 2022
MDR, News in Brief

elFU rules under the EU‘s MDR

January 26, 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
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
IVDR, MDR, News in Brief

EU clearance for MDR and IVDR harmonised standards

May 28, 2021
IVDR, MDR, News in Brief

EU – Switzerland MRA expired

May 27, 2021
IVDR, MDR, News in Brief

Guidance on legacy devices regarding Eudamed

May 3, 2021
Important Notice, IVDR, MDR

New guidance documents published by the European Commission

May 2, 2021
Important Notice, IVDR, MDR

Updated EUDAMED implementation dates

April 1, 2021
Important Notice, IVDR, MDR

MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality

March 15, 2021
IVDR, MDR, News in Brief

Voluntary registration with EUDAMED database – industry fears duplicate registrations

January 23, 2021
Important Notice, MDR

mdi Europa experience on MDR technical documentation reviews

January 14, 2021
Important Notice, MDR

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 2020
IVDR, MDR, News in Brief

New website on actor registration in EUDAMED 3 available

October 29, 2020