ANRP ArrêtéArrêté 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.
Arrêté n° 633 du 22 décembre 2025 is the official ANRP identifier for “Réglementation des dispositifs médicaux à usage humain”. Arrêté n° 633 du 22 décembre 2025 is the official identifier ANRP uses for this instrument.
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Réglementation des dispositifs médicaux à usage humain
Signed eleven-page device order of 22 December 2025, citing Decree 2025-149. Article 21 requires prior declaration by each supply-chain actor and refers to Annex V. Article 22 establishes device homologation, a five-year renewable AMM, class A registration and a separate Board fee resolution; the actual homologation list remains to be determined by ministerial order and must include at least classes B, C and D. The collected 41-page companion attachment contains Annexes I–IV and VI, but Annex V is not present in that expression. This does not prove that no other official expression exists. Articles 5–6 bind essential requirements to Annex III, whose section B expressly excludes IVDs. All 11 main-order pages were read and visually checked. Gazette publication, later amendments, the specific list, Annex V and later fee decisions remain unverified.
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.