Tag: IVDR

Important Notice

EU AI Act approved by Parliament

July 3, 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
Important Notice

Registering a legacy device in Eudamed is a good step

May 12, 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
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
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

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
Important Notice, IVDR, MDR

New MDCG guidance documents under the MDR and IVDR

June 7, 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
Important Notice, IVDR

IVDR clinical evidence

February 3, 2022
Important Notice, IVDR

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

January 5, 2022
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
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