Category: News in Brief

Important information on MDR, IVDR, Guidance Documents, European Commission and other news related to CE Marking of Medical Devices.

IVDR, MDR, News in Brief, Partners

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

October 15, 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
COVID-19, News in Brief

The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD

August 5, 2021
MDR, News in Brief

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

August 1, 2021
News in Brief

bsi develops guidelines for the application of ISO 14971 to artificial intelligence and machine learning

July 12, 2021
News in Brief

The IVDR and performance evaluation studies

July 8, 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
COVID-19, News in Brief

Guidance document on the impact of genetic variants on SARS-COV-2

May 29, 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
COVID-19, News in Brief

Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons

March 8, 2021
COVID-19, News in Brief

European Commission publishes Q&A guidance on COVID-19 tests

March 1, 2021
IVDR, MDR, News in Brief

Voluntary registration with EUDAMED database – industry fears duplicate registrations

January 23, 2021
Brexit, News in Brief

Additional MHRA guidance for medical device companies

January 17, 2021
News in Brief

BfArM informs about damages to hip implants

December 13, 2020
IVDR, News in Brief

EU IVD medical devices sector destined for crisis?

November 6, 2020
IVDR, MDR, News in Brief

New website on actor registration in EUDAMED 3 available

October 29, 2020
Brexit, News in Brief

Latest UK MHRA updates on Northern Ireland and EU device regulation guidance

October 26, 2020
IVDR, MDR, News in Brief

Practical advice for setting up an MDR and IVDR compliant PMS Plan

October 22, 2020
IVDR, MDR, News in Brief

Get ready for the economic operator registration in EUDAMED

October 9, 2020
Brexit, News in Brief

New UKCA mark after Brexit

September 17, 2020
IVDR, MDR, News in Brief

EUDAMED economic operator registration module available as of December 2020

September 16, 2020
News in Brief

Guidance checklist for manufacturers of reusable and resterilizable medical devices

September 3, 2020
MDR, News in Brief

Commission to put forward another European standards request

August 24, 2020
IVDR, MDR, News in Brief

New guidance document shows how to use MDSAP audit reports for MDR/ IVDR surveillance audits

August 21, 2020
IVDR, MDR, News in Brief

Updated Q&A document on MDR and IVDR UDI requirements from the European Commission

August 12, 2020
MDR, News in Brief

ISO TR 20416 and PMS under the MDR

August 1, 2020
COVID-19, News in Brief

Update from the European Commission for protective equipment in the COVID-19 crisis

July 20, 2020