New updates to MDCG Guidance document released | QbD Group

The documents are available in the Notified Body section of the MDCG Guidance webpage. The application forms are to be used by conformity assessment bodies that seek designation (or extension of designation) as notified body under MDR or IVDR. The preliminary assessment review (PAR) templates will be used by the designating authorities to document their review of the conformity assessment body’s application.

MDCG 2021-15 Rev. 1: Application form for designation as a notified body or extension of the scope of designation under Regulation (EU) 2017/745 on medical devices (MDR).

MDCG 2024-7 Rev. 1: Preliminary assessment review template – MDR (Regulation (EU) 2017/745).

MDCG 2021-15/MDCG 2024-7: Annex to Application Form & PAR Template MDR (List of documents).

MDCG 2021-16 Rev. 1: Application form for designation as a notified body or extension of the scope of designation under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

MDCG 2024-8 Rev. 1: Preliminary assessment review template – IVDR (Regulation (EU) 2017/746).         

MDCG 2021-16/MDCG 2024-8 Annex: Annex to Application Form & PAR Template IVDR (List of documents).

What is updated:

• MDCG 2021-15 and MDCG 2021-16 were updated to align the document structure with respectively MDR Annex VII and IVDR Annex VII, and related Preliminary assessment review (PAR) form templates (respectively MDCG 2024-7 and MDCG 2024-8)
• MDCG 2024-7 and MDCG 2024-8 were updated by removing in each document a section due to redundancy in its use by notified bodies.
• The Annexes to each Application Form and PAR template contain a checklist of documents to be submitted with the application

What does it mean to you?

MDCG 2021-15/16, MDCG 2024-7/8 and the annexes to these documents are of relevance for the designation of notified bodies under MDR and IVDR. As such, they do not have an immediate impact on manufacturers and other economic operators under IVDR or MDR.

They are of interest for those who wish to better understand the designation process of notified bodies under the medical device Regulations.