New guidance documents available for MDR/IVDR

Now available from the Commission website are the following new guidance and informational documents:

• MDCG 2021-22 rev.1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies
• MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies
• MDCG 2022-14 – Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs
• MDCG 2022-15 – Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR
• Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices – Version 1
• Background note on the use of the Manual on borderline and classification for medical devices under the Directives