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 carefully 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 from the European Commission website, click here.
In addition to the MEDDEV guidelines, the Commission has also published 'Interpretive Documents' (latest versions of the first two published August 2009) on the following subjects, including the long-awaited guidance on how to apply the requirements of the Revising Directive 2007/47/EC to the MDD and AIMDD:
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 guideance documents are addressed, in the main, to the Notified Bodies. Links to both sets of documents are provided below.