16th IMDRF meeting in Russia, September 2019 – meeting documents now available

The last meeting of the IMDRF took place in Yekaterinburg in Russia on 16-18 September and the outcome statement of the IMDRF management committee (MC) as well as the presentations delivered during the stakeholders’ meeting are now available on the IMDRF website.

Included among the documents are the following final versions related to clinical affairs:

• Clinical Evidence – Key Definitions and Concepts (N55);
• Clinical Evaluation (N56); and
• Clinical Investigation (N57).

Guidances N55 and N56 supersede May 2007 versions with the same titles, while N57 replaces a February 2010 version.

In 2020, Singapore takes over the chairmanship of the IMDRF. The 17th meeting and stakeholder forum will be held on Tuesday, 17 March 2020 at Matrix Level 2, Auditorium, 30 Biopolis Street, Singapore 138671.