Tag: MDR

Important Notice

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

September 12, 2023
News in Brief

Harmonization of MDR and IVDR standards still slow

August 14, 2023
Important Notice

A closer look at MDCG 2023-3 on vigilance

August 11, 2023
News in Brief

Cybersecurity expertise shortage in EU

August 7, 2023
Library, Supportive Information

Supportive Information Section mdi Europa

August 1, 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

Swiss Federal Council to mirror extended transition timelines for MDR legacy devices

June 2, 2023
News in Brief

Spain brings in additional national requirements

May 27, 2023
Important Notice

Registering a legacy device in Eudamed is a good step

May 12, 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

Guidance document on in-house devices

February 15, 2023
Important Notice

European Commission proposal for extended transition timelines published

January 12, 2023
IVDR, MDR, News in Brief

EU guidance on authorised representatives

January 11, 2023
News in Brief

EU notified bodies on harmonised standards regarding cybersecurity

January 6, 2023
Brexit

Extra year for CE-marked devices to access UK market

January 6, 2023
Important Notice

European Commission proposed MDR deadlines extension for legacy devices

December 14, 2022
News in Brief

EU notified body technical documentation reviews

November 17, 2022
News in Brief

Cybersecurity in the EU

November 8, 2022
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

Danger of cybersecurity attacks?

September 26, 2022
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