• 2024-01-26 06:58:53

This guidance explains the qualification and classification of products without an intended medical purpose listed in Annex XVI of the MDR.

• 2024-01-26 06:51:35

This guidance provides demonstration of equivalence for products without an intended medical purpose listed in Annex XVI of the MDR.

• 2023-09-27 07:30:22

A survey on certifications and applications of MDR-IVDR was conducted in April 2023. The result of the survey is published.

• 2023-02-23 02:02:05

According to the MDR and the IVDR, notified bodies shall make their standard fees public. In this guidance, the MDCG clarifies the requirements of the list of standard fees and provides the corresponding templates.

• 2023-02-23 01:59:23

The statistics as of January 2023 regarding the coverage of designation codes by MDR/IVDR notified bodies has been published in the attachment.

• 2022-09-27 08:26:27

MDCG 2022-13 aims to provide guidance to the authorities responsible for notified bodies and joint assessment teams when conducting assessments of conformity assessments bodies and re-assessments of notified bodies.

• 2020-02-21 07:19:00

Eight notified bodies have now been registered with the CDSCO intends to carry out audit of a manufacturing site of Class A or Class B of medical devices.