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NEWS

News in Brief

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

July 16, 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

BfArM Recommendation on Paclitaxel-coated Stents and Balloons

June 13, 2019
News in Brief

LRQA to Withdraw Notified Body Services

June 13, 2019
News in Brief

Quality Assurance Agreements (QAA)

June 11, 2019
News in Brief

EU Guidance on Quality Rules for Drug-Device Combinations

June 4, 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

The World Health Organisation’s (WHO) New Draft Guideline

May 28, 2019
News in Brief

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

May 20, 2019
News in Brief

Swiss Medical Device Manufacturers Under Pressure

April 26, 2019
News in Brief

Draft Policy on Remaining Shelf-Life for Medical Products

April 17, 2019
News in Brief

Updated Clinical Evaluation Guidance on Comparability

April 8, 2019
Important Notice, News in Brief

Device Registration and Legacy Devices

April 2, 2019
News in Brief

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

March 22, 2019
Brexit

Details about the Regulation of Medical Devices in Case of No-Deal Brexit

February 28, 2019
Brexit

Brexit Key Challenges – a Brief Case Study

February 15, 2019
Brexit

What about Brexit?

December 21, 2018