🇪🇺 Live Medical Devices & Diagnostics

EU Medical Device Regulation (Regulation 2017/745)

Governs the safety, clinical evaluation, and post-market surveillance of medical devices in the EU.

View official source document

Rules extracted

362

Obligations decomposed

21.3x

Avg obligations per rule

🇪🇺 European Union

Jurisdiction

About this regulation

Regulation (EU) 2017/745 establishes the regulatory framework for medical devices in the European Union. It replaces Council Directives 90/385/EEC (active implantable medical devices) and 93/42/EEC (medical devices). The MDR introduces stricter pre-market requirements, enhanced clinical evidence obligations, a Unique Device Identification (UDI) system, the EUDAMED database, and strengthened post-market surveillance and vigilance obligations. It applies from 26 May 2021 with transitional provisions extending to 2027-2028.

What AuditDSS covers

Source

Regulation

Extracted

Rules

Decomposed

362

Obligations

21.3x

Decomposition ratio

Each rule is decomposed into an average of 21.3 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 362 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in MDR is scored across independent risk dimensions:

Obligation Weight

How critical within the regulatory framework

Violation Likelihood

How often breached in practice

Enforcement Evidence

Regulator enforcement history and penalties

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title: EU Medical Device Regulation (Regulation 2017/745)
Regulatory body: European Parliament and Council
Jurisdiction: 🇪🇺 European Union
Document type: regulation
Effective date: May 26, 2021
Issuing authority: European Parliament and Council of the European Union
Industry: Medical Devices & Diagnostics
Official source: View source document ↗

Who this applies to

medical device manufacturersauthorised representativesimportersdistributorsnotified bodieshealth institutions

Key requirements

general safety and performance requirements
clinical evaluation
conformity assessment
UDI system
EUDAMED registration
post-market surveillance
vigilance reporting
CE marking

Frequently asked questions about MDR

What is MDR?

Who does MDR apply to?

MDR applies to medical device manufacturers, authorised representatives, importers, distributors, notified bodies, health institutions.

How many obligations does MDR contain?

AuditDSS has decomposed MDR into 362 atomic obligations from 17 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of MDR?

The key requirements include: general safety and performance requirements, clinical evaluation, conformity assessment, UDI system, EUDAMED registration, post-market surveillance, vigilance reporting, CE marking.

How can I assess my MDR compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 362 MDR obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces MDR?

MDR is enforced in European Union by European Parliament and Council.

When did MDR come into effect?

MDR became effective on May 26, 2021.

What industry does MDR apply to?

MDR is primarily relevant to the Medical Devices & Diagnostics industry. AuditDSS covers 64 regulations in this industry sector.

Build a MDR compliance pack

Don't have a compliance policy yet? AuditDSS generates a complete compliance pack for MDR — alone or combined with other regulations your business needs. Every clause is mapped to specific obligations.

Policy

High-level commitments and governance framework covering MDR requirements.

Procedures

Step-by-step operational procedures to implement each policy commitment.

Forms & checklists

Ready-to-use forms, registers, and checklists for day-to-day compliance operations.

Multi-regulation

Combine MDR with other regulations into a single unified compliance pack for your business.

Build MDR compliance pack

Already have a policy? Assess it against MDR

Upload your document

Upload your compliance policy, program manual, or operational document. AuditDSS accepts any text-based document.

AI maps against 362 obligations

Your document is scored against every obligation in MDR. Each claim is mapped to the obligation tree and evaluated for coverage.

Risk-scored gap report

Receive every gap ranked by risk priority with remediation guidance, enforcement evidence, and cascade impact analysis.