Tag: Guidance Documents

Important Notice

Guidance document for class I device manufacturers

December 23, 2019
News in Brief

Guidance on Qualification and Classification of Software under the MDR and IVDR Published

October 28, 2019
Important Notice, IVDR

Performance Evaluation for IVD Medical Devices

October 28, 2019
Important Notice

MDCG Guidance on MDD Certificates and SSCP under the MDR

October 15, 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

EU Guidance on Quality Rules for Drug-Device Combinations

June 4, 2019
News in Brief

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

May 28, 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