Tag: MDR

News in Brief

New Notified Bodies Designated under the MDR and IVDR

October 15, 2019
News in Brief

News from the Commission – Notified Bodies and a Potential MDR Extension for Selected Devices

September 4, 2019
Important Notice, News in Brief

European Commission Website on Regulations MDR / IVDR Restructured

August 21, 2019
News in Brief

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

July 17, 2019
Important Notice, News in Brief

Guidance on Person Responsible for Regulatory Compliance

June 23, 2019
News in Brief

Guidance on Implant Cards

June 23, 2019
Important Notice, News in Brief

Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics

June 14, 2019
News in Brief

Quality Assurance Agreements (QAA)

June 11, 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
News in Brief

Guidance on Article 54(2)b of Regulation (EU) 2017/745 on medical devices (MDR)

March 22, 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