EU MDR 2017/745 Compliance Services

Understand and Navigate the Regulation

The European Union Medical Device Regulation (EU MDR 2017/745) is the core legal framework for medical devices in the EU. It replaces the older MDD and imposes stricter standards for safety, clinical evidence, and post-market monitoring.

Abstract visual of EU MDR 2017/745 compliance featuring icons of a document, EU stars, heart monitor, syringe, and gavel in flat blue tones.

What the MDR Demands

The EU MDR 2017/745 significantly increases the regulatory obligations placed on medical device stakeholders. Here are the key requirements in greater detail:

Clinical Evaluation & Supporting Evidence

Manufacturers must provide robust clinical data demonstrating the safety and performance of their device throughout its life cycle. This includes a Clinical Evaluation Report (CER), post-market clinical follow-up (PMCF) plans, and updated documentation for each device class.

Technical Documentation (Annex II & III)

Full and up-to-date documentation must be maintained and ready for review by notified bodies and authorities. This includes detailed design specifications, risk management, verification and validation data, and post-market monitoring procedures.

UDI and EUDAMED Registration

All devices must have a Unique Device Identifier (UDI) to enhance traceability. Manufacturers are also required to register their products, economic operators, and vigilance reports in EUDAMED, the European Database on Medical Devices.

Post-Market Surveillance (PMS), Vigilance, and PSURs

A proactive PMS system is mandatory. Manufacturers must analyze field data, implement corrective actions, and report serious incidents through vigilance reporting. Periodic Safety Update Reports (PSURs) are required for Class IIa and higher.

Quality Management System (ISO 13485 Alignment)

A certified quality management system, aligned with ISO 13485, is expected. It must cover lifecycle planning, document control, supplier management, CAPA processes, and internal auditing.

Clear Labelling and Instructions for Use (IFU)

Devices must include transparent, multilingual labels and comprehensive Instructions for Use that align with Article 10 and Annex I.

Heightened Oversight of High-Risk Devices

Class III and implantable devices are subject to additional scrutiny, including expert panels, pre-market consultation procedures, and stricter clinical evaluation.

Who’s Affected?

All economic operators involved in the lifecycle of a medical device destined for the EU market:

  • Manufacturers (both EU and non-EU)

  • Authorized Representatives

  • Importers

  • Distributors

Each party has distinct legal responsibilities under MDR Articles 10-14, including documentation maintenance, product verification, traceability, and reporting obligations.

How Wintersmith Advisory Can Help

We offer deep regulatory expertise to guide your organization through the full lifecycle of EU MDR compliance:

  • Annex I Gap Assessments: Evaluate compliance with General Safety and Performance Requirements (GSPRs) and identify technical and procedural shortfalls.

  • Technical Documentation Support: Develop and remediate Annex II & III-compliant documentation, including CERs, risk management files, and device descriptions.

  • UDI and EUDAMED Strategy: Define a clear plan for UDI assignment, labelling integration, and EUDAMED economic operator and product registration.

  • ISO 13485 QMS Integration: Implement or upgrade your QMS to align with MDR requirements through practical, audit-ready processes.

  • PMS and PMCF Planning: Create and execute post-market strategies including PMCF study design, data analysis, and corrective action planning.

  • Internal Audits and Notified Body Preparation: Conduct MDR-focused internal audits, address CAPAs, and prepare documentation and teams for notified body review.

The Cost of Non-Compliance

Ignoring or delaying EU MDR alignment exposes companies to significant risks:

  • Loss of CE marking and market access

  • Product recalls and import/export blocks

  • Financial penalties and legal consequences

  • Reputational harm and customer loss

Early action not only avoids disruption—it protects your business and enhances market credibility.

Why Work With Us

At Wintersmith Advisory, we combine regulatory precision with real-world implementation. Our consultants bring hands-on experience across the EU MDR landscape, from Class I to Class III devices. We don’t just advise—we help you execute.

Whether you’re placing a new product on the market or re-certifying a legacy device, our structured approach keeps your timeline on track and your compliance watertight.

Let’s Talk Compliance

Ready to start? Schedule a consultation to explore your needs and receive tailored guidance on your next steps.

Book a Consultation or Contact Us

Contact us.

info@wintersmithadvisory.com
(801) 558-3928