ANRP AnnexesAnnexes à l’Arrêté n° 633 du 22 décembre 2025
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Annexes à l’Arrêté n° 633 du 22 décembre 2025 is the official ANRP identifier for “Annexes relatives à la réglementation des dispositifs médicaux à usage humain”. Annexes à l’Arrêté n° 633 du 22 décembre 2025 is the official identifier ANRP uses for this instrument.
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Annexes relatives à la réglementation des dispositifs médicaux à usage humain
Official 41-page companion attachment to Order 633 of 22 December 2025. It contains Annex I terminology, Annex II classification, Annex III essential requirements, Annex IV establishment conditions and Annex VI device AMM/renewal dossiers and product-characteristics form. Annex V cited by the main order is not present in this 41-page expression; no conclusion is drawn about other official expressions. Annex III has general requirements and a section B explicitly for devices other than DMDIV; its B requirements must not be generalized to IVDs. The source heading Annexe VI is retained. All page structures were checked; 29 selected page bodies were read. Later amendments and completeness of the legally referenced annex set remain unverified.
Annexes à l’Arrêté n° 633 du 22 décembre 2025 is the official identifier ANRP uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.