Regulayer™ / The 156 laws / Pharma & life sciences
EU · MDR / IVDR
Medical-device documentation, traceability & vigilance.
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Citation: Reg (EU) 2017/745 Arts 10/27-29/83-88; Reg (EU) 2017/746
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What to do about it
Keep the evidence this asks for, as the work happens.
A consequential AI-proposed action is checked against the human authority in force at that moment, and the decision leaves a signed record that a third party can verify independently, offline, without Regulayer™. It runs inside your own environment and nothing has to leave it.
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Part of the Regulayer™ proof catalogue: 156 laws and standards, one sealed engine. This page is a product description, not legal advice.
What the statute requires, section by section
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Provisions addressed:
- MDR Art. 10
- General obligations of manufacturers: maintain technical documentation (Annexes II & III), keep an up-to-date list of UDIs; retain documentation (>=10 years; >=15 for implantables).
- MDR Arts. 83-86
- Post-market surveillance system, PMS plan, PMS report / PSUR.
- MDR Arts. 87-88
- Vigilance: reporting of serious incidents and field safety corrective actions (deadlines from 2 to 15 days).
- MDR Arts. 27-29
- UDI system and traceability; Annex I (general safety and performance requirements) for electronic programmable systems/software. IVDR (Regulation (EU) 2017/746) carries parallel obligations. MDR date of application 26 May 2021; IVDR 26 May 2022 (each with staggered transitions).
Taken from the Regulayer™ entry for this instrument, which is built against the primary text.
This is the duty on the business. For what a lawyer in Europe must disclose about using AI in a filing, see Europe: the EU AI Act, the CCBE guides, and what Germany tells its lawyers.