What does EU · MDR / IVDR cover?

Medical-device documentation, traceability & vigilance. It applies to: Medical-device & IVD manufacturers (EU).

What does the Regulayer pack for EU · MDR / IVDR prove?

Device-record, UDI/traceability, and serious-incident detail for medical-device makers. The record is signed and tamper-evident, and anyone can verify it free, without an account.

Regulayer / The 146 laws / Pharma & life sciences

EU · MDR / IVDR

Medical-device documentation, traceability & vigilance.

Instrument: Regulation, legally binding in the EUApplies to: Medical-device & IVD manufacturers (EU). Built · MDR 2021 / IVDR 2022

What the signed record shows

Device-record, UDI/traceability, and serious-incident detail for medical-device makers.

The proof is a signed, tamper-evident record. Anyone can check it, free, without an account, and nothing has to leave the building to make it. Evidence, not a promise.

Citation: Reg (EU) 2017/745 Arts 10/27-29/83-88; Reg (EU) 2017/746

In the same family

FDA · 21 CFR Part 11Electronic records & signatures EU GMP · Annex 11Computerised-systems integrity FDA-EMA · Good AI Practice (Jan 2026)Data governance, performance, life-cycle management

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.

Life sciences: how the control works Or verify a real record, free →

Part of the Regulayer proof catalogue: 146 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.