EU Medical Devices Regulation (MDR 2017/745)
MDR - Notified Bodies (Ch IV)

EU Medical Devices Regulation (MDR 2017/745) MDR-Art.35_36_37_38_39_40_41_42_45_46_47_50: Notified bodies - authorities, requirements, subsidiaries, designations and re-assessment (Articles 35-50 selected)

Articles 35-38 govern designation of authorities responsible for notified bodies + the substantive NB requirements + the designation + notification procedure. Article 39 sets NB identification numbers. Article 40 governs monitoring + re-assessment of NBs. Article 41 covers review of NB assessments. Article 42 covers changes to designations. Articles 45-47 cover NB exchange of experience + coordination. Article 50 lists NB operational obligations including independence + impartiality + competence + transparency + fees.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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