AMDM OrdinulOrdinul nr. Rg04-264 din 08.09.2026
Ordinul nr. Rg04-264 din 08.09.2026 is the official AMDM identifier for “Notification and Registration of CE-Marked Medical Devices in the State Register — Administrative Procedure and User Instruction”. Ordinul nr. Rg04-264 din 08.09.2026 is the official identifier AMDM uses for this instrument.
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- Ordinul nr. Rg04-264 din 08.09.2026
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- 8 September 2026
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Notification and Registration of CE-Marked Medical Devices in the State Register — Administrative Procedure and User Instruction
Ordinul Agenției Medicamentului și Dispozitivelor Medicale nr. Rg04-264 din 08.09.2026, signed by the Director on 8 September 2026 and in force from signature. It approves, under art. 4 alin. (2) lit. b) and e), art. 7 and art. 17 alin. (1) of Legea nr. 102/2017 cu privire la dispozitivele medicale and the Administrative Code, (1.1) the administrative procedure for the notification and registration of CE-marked medical devices in the State Register of Medical Devices (Annex No. 1) and (1.2) the user instruction for the electronic service "Cabinetul personal al reprezentantului autorizat" (Annex No. 2); and it repeals three earlier orders that governed the same ground (nr. A07.PS-01.Rg04-201 of 13.10.2017, nr. Rg04-000123 of 20.05.2024 and nr. Rg04-000367 of 06.12.2024). Annex No. 1 is the substantive instrument: Chapters I–VI (§1–§51) cover the general provisions and the RSDM, access to the personal cabinet, registration of the manufacturer, the applicant's preliminary obligations, notification and registration of the device in five sections (filing of the dossier; examination and registration; rejection and appeal; updating and erasure of RSDM data; the applicant's liability) and the final provisions; there follow the annex to the Procedure — the minimum requirements for the content of the agreement between the manufacturer and the authorised representative (general provisions, the registration and conformity-assessment procedure, the information the manufacturer must provide, the safeguard clause, vigilance, delegated devices, enforcement measures) — and the form annexed to those minimum requirements. Annex No. 2 is operational only, and carries its own annexes 1–3, the forms used in the electronic service. The order's own first pages are an OCR text layer with broken diacritics ("Se aprob6", "Instrucliunea", "Agenliei", "Ei" for "și"); the corpus preserves that text layer as the source states it rather than repairing it, while Annex No. 1 onward is clean.
Ordinul nr. Rg04-264 din 08.09.2026 is the official identifier AMDM uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.