ComplianceEU

EU Medical Device Regulation (MDR) 2017/745 Compliance

Build an MDR operating model you can execute and maintain.

This guide focuses on high-signal decisions and audit-ready evidence outputs: scope, classification, route, technical file, clinical evidence, PMS/vigilance, and UDI/EUDAMED.

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Author

Sorena AI

Published

Feb 22, 2026

Updated

Feb 22, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published Feb 22, 2026

Updated Feb 22, 2026

Overview

MDR compliance is a lifecycle system. The fastest way to get stuck is to treat MDR as a one-time documentation project. The fastest way to move is to build an operating model where scope and classification decisions drive a route, route drives evidence, and post-market signals drive updates - with clear owners, review gates, and traceability.

Section 1

The MDR compliance system (the evidence chain you must control)

Think of MDR as a connected evidence chain. If one link is missing (e.g., claims not aligned to clinical evidence, PMS not tied to CAPA, or UDI records not tied to labeling), the whole chain becomes hard to defend.

Practical output: a single device compliance dossier map that lists each required artifact and where it lives.

Scope memo plus economic-operator role map to avoid mis-scoping and mis-owned obligations.
Classification memo to determine the conformity-assessment route and notified-body involvement.
Technical documentation (Annex II and III) plus GSPR checklist (Annex I) as the evidence backbone.
Clinical evaluation (Annex XIV) plus PMCF where needed to support claim justification and residual-risk acceptability.
PMS and vigilance plus the CAPA feedback loop to control the lifecycle and trigger updates.
UDI and EUDAMED procedures plus data governance to support traceability and registry correctness.

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Section 2

High-signal decisions that reduce time and rework

Make these decisions early and document them. Each one eliminates weeks of churn later.

Operational rule: every decision should have an owner, an artifact (memo), and a change trigger.

Intended purpose and claim set (including UI outputs and decision support language).
Qualification and classification (Annex VIII; software Rule 11 if relevant).
Conformity assessment route (Annex IX/X/XI) and notified body engagement plan (if required).
Clinical evidence strategy: what claims require what evidence; equivalence strategy (if any).
PMS and vigilance model: data sources, signal detection, and escalation workflows.
UDI and EUDAMED model: actor registration roles, device/UDI record lifecycle, and data quality controls.

Section 3

30/60/90-day plan (practical sequencing for teams that need momentum)

Your exact sequence depends on class and device type, but most teams benefit from a short, execution-oriented plan that produces artifacts early.

Use this as a starting point and adapt based on route and notified body needs.

Days 0-30: scope memo, role map, classification hypothesis, route shortlist, technical file index draft, gaps list.
Days 30-60: QMS procedures and change control, GSPR checklist skeleton, risk management alignment, CER plan and evidence mapping, PMS plan draft.
Days 60-90: close evidence gaps, finalize CER (or plan investigations), implement PMS/vigilance workflows, prepare UDI/EUDAMED roles and data model, run internal audit-style review.

Section 4

Notified body readiness (if you need NB involvement)

If your route requires a notified body, your goal is to submit a coherent, reviewable package - not a large folder of unrelated documents.

Practical output: an NB submission pack index mapping Annex requirements to your evidence artifacts.

Keep device family boundaries consistent across technical file, CER, PMS plan, and labeling.
Make change history explicit (device versions, software releases, significant changes, rationale).
Ensure traceability from GSPR to risk controls, test evidence, clinical evidence, and labeling statements.
Include PMS readiness evidence (procedures, data sources, signal management) - not just a draft plan.
Prepare reviewer shortcuts such as claim-to-evidence tables, risk summary tables, and key conclusions.

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