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Guidance Documents: EUROPE

EUROPEAN COMMISSION GUIDELINES

The guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health.

They have been drafted through a process of consultation with various interested parties during which intermediate drafts were circulated and comments were taken up in the documents. Therefore, they reflect positions taken in particular by representatives of Competent Authorities and Commission Services, Notified Bodies, industry and other interested parties in the medical devices sector.

To download the guidelines for the AIMDD/MDD/IVDD from the European Commission website, click here. To download the guidelines for the MDR/IVDR, click here.

There are two ‘borderline’ manuals, one for the AIMDD/MDD/IVDD (Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, Version 1.22, May 2019) and one for the MDR/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, September 2022).


NOTIFIED BODY GUIDANCE DOCUMENTS

Notified Body guidance documents fall into two groups – those issued by the Notified Bodies themselves (NB-MED), some of which have been adopted by the European Commission as official ‘MEDDEV’ guidance documents, and those issued by the Notified Bodies Oversight Group (NBOG), whose guidance documents are addressed, in the main, to the Notified Bodies. Links to both sets of documents are provided below.

NB-MED Documents: http://www.team-nb.org/nb-med-documents/

NBOG Documents: https://www.nbog.eu/nbog-documents/