Obelis O.E.A.R.C.

MEDDEV 2.12-1 rev 6 replacing rev 5

A MEDDEV (for Medical Devices), as commonly named, is a EU Guidelines document aiming to promote 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 Market & Public Health Vigilance.

MEDDEV are drafted through a process of consultation with various interested parties during Expert meetings (e.g. MDEG) drafts are circulated and comments are exchanged were taken up in the documents. They reflect positions adopted by representatives and experts of EU Member States Competent Authorities, EU Commission Services, Notified Bodies, Industry and other interested third parties involved in the medical devices field.

These guidance documents are not legally binding.

Due to the participation of all the above mentioned parties in the elaboration of these guidelines, it is expected that they will be followed by the Member States and, consequently, will enable a better harmonized application of the relevant Directives requirements. MEDDEV documents, as such, are subject to regular updates.

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