Author: Michael Sander

News in Brief

Recommendation of BfArM regarding Breathing Hoses in Anesthesia

July 22, 2019
News in Brief

Most Important Changes – Regulation (EU) 2017/745 on Medical Devices (MDR)

July 17, 2019
News in Brief

Most Important Changes – Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)

July 16, 2019
News in Brief

BfArM Recommendation on Paclitaxel-coated Stents and Balloons

June 13, 2019
News in Brief

Spain’s Only Notified Body Not Accepting Applications for Certification of New Products

June 3, 2019
News in Brief

European Commission Confident that the MDR and the IVDR are on Track

May 30, 2019
News in Brief

EU Authorities Might Review Products in Case of Notified Body (NB) Shortage

May 20, 2019
CE Marking, MDR

Technical Documentation Requirements under the MDR – a Case Study

January 14, 2019
CE Consulting, IVDR, MDR

Notified Body Selection and Change

December 15, 2018
News in Brief

Why is a Clinical Evaluation so Important?

December 11, 2018
News in Brief

Labeling Changes under the Regulation (EU) 2017/745 on medical devices (MDR)

December 4, 2018
EU Authorized Representative, Important Notice

How to change your EU Authorized Representative

November 14, 2018