Author: Michael Sander

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
Important Notice, MDR

New European Commission guidance document on MDR medical device classification

October 11, 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
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
Important Notice

Insufficient sterilization of medical devices by Steril Milano S.r.l

June 28, 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
Important Notice, IVDR

IVD or not IVD? That is the question…

April 15, 2021
Important Notice, MDR

mdi Europa experience on MDR technical documentation reviews

January 14, 2021
News in Brief

BfArM informs about damages to hip implants

December 13, 2020
Important Notice

Key guidance document on the classification of IVDs under the IVDR

December 1, 2020
IVDR, News in Brief

EU IVD medical devices sector destined for crisis?

November 6, 2020
Important Notice, MDR

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 2020
IVDR, MDR, News in Brief

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

October 22, 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
MDR, News in Brief

ISO TR 20416 and PMS under the MDR

August 1, 2020
Important Notice

EU guidance on Notified Body clinical evaluation assessment reports

July 24, 2020
MDR, News in Brief

European Commission’s device standardisation request rejected

June 23, 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
Important Notice

Medical Device Distribution in France

May 18, 2020
Important Notice, MDR

Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published

April 29, 2020
Important Notice, MDR

MDR Postponed by One Year!

April 28, 2020
Important Notice, MDR

MDR Postponement – Handle with Care!

April 21, 2020
Important Notice, IVDR, MDR

MDR and IVDR guidance updates

April 9, 2020
Important Notice, MDR

Latest MDCG Preparedness Plan and MDR Delay

March 26, 2020
News in Brief

Usability and the MDR

March 12, 2020
News in Brief

Update on Notified Bodies

March 4, 2020