Tag: Guidance Documents

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
IVDR, News in Brief

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

March 4, 2022
COVID-19, News in Brief

New guidance for third-country manufacturers of COVID-19 IVD tests

February 6, 2022
Important Notice, IVDR

IVDR clinical evidence

February 3, 2022
IVDR, MDR, News in Brief

MDCG guidance document on distributors and importers published

December 12, 2021
MDR, News in Brief

New guidance on legacy devices published

November 12, 2021
Important Notice, MDR

New European Commission guidance document on MDR medical device classification

October 11, 2021
COVID-19

SARS-CoV-2 IVD tests and the IVDR

October 7, 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
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
Important Notice, IVDR

IVD or not IVD? That is the question…

April 15, 2021
Important Notice

Key guidance document on the classification of IVDs under the IVDR

December 1, 2020
Important Notice, MDR

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 2020
IVDR, MDR, News in Brief

Get ready for the economic operator registration in EUDAMED

October 9, 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
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
Important Notice

EU guidance on Notified Body clinical evaluation assessment reports

July 24, 2020
Important Notice, MDR

Clinical evaluation and equivalence – using literature under the MDR

June 5, 2020
IVDR, MDR, News in Brief

New MDR and IVDR guidance documents published by MDCG and MedTech Europe

June 1, 2020
COVID-19, Important Notice, News in Brief

Surgical and FFP masks in the COVID-19 crisis

May 8, 2020
Important Notice, MDR

Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published

April 29, 2020
COVID-19, Important Notice

European Commission gives details of how to prevent COVID-19 test failures

April 23, 2020
Important Notice, IVDR, MDR

MDR and IVDR guidance updates

April 9, 2020
COVID-19, Important Notice

Guidance on MD and PPE in times of COVID-19 and local provisions

April 9, 2020
Important Notice, News in Brief

European Commission Recommendation on Regulatory Exemptions for COVID-19 Products

March 23, 2020
Important Notice

New guidance documents for EMDN and cybersecurity

February 13, 2020
Important Notice

MDCG guidance documents on MDR codes and sampling of MDR and IVDR devices published

January 6, 2020