EU MDR Consulting

EU MDR Consulting

Under the EU Medical Device Regulation (MDR 2017/745), all devices must bear a CE marking before being placed on the EU market, and all manufacturers are required to register in EUDAMED. Low‑risk Class I devices (non‑sterile, non‑measuring) may be self‑declared, but all other device classifications must undergo conformity assessment by a Notified Body and maintain an ISO 13485‑certified quality management system. Compliance extends into EUDAMED’s modules for UDI/device registration, vigilance, and post‑market surveillance.

Whether you have a legacy device transitioning under the MDR or you seek EU CE Marking for the first time, Pure Global’s MDR consultants can help you create an MDR compliance strategy from device development to post-market surveillance. We operate more than 15 offices across five continents, where we offer local support in the industry’s largest markets. Our team of experienced medical device regulatory, clinical, and quality experts leverage AI-driven tools and regulatory data analytics to streamline the compliance process.

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EU MDR Information

Medical Device Registration Process in the European Union (EU MDR)

STEP 1: CLASSIFICATION & SCOPE
Determine whether the product qualifies as a medical device under the EU Medical Device Regulation (MDR) 2017/745 by assessing its intended purpose. Confirm the device classification (Class I (including Is, Ir, Im), IIa, IIb, or III) based on the rules in Annex VIII of the MDR. Finally, select the appropriate conformity assessment route.

STEP 2: QUALITY MANAGEMENT SYSTEM & COMPLIANCE
Establish a Quality Management System (QMS) that conforms to EN ISO 13485. Appoint a Person Responsible for Regulatory Compliance (PRRC) as required under Article 15. Demonstrate conformity with the General Safety and Performance Requirements (GSPRs) outlined in Annex I and apply relevant EU legislation, state-of-the-art standards and common specifications to support compliance. Obtain the Basic UDI-DI from a designated UDI issuing entity, such as GS1, HIBCC, or ICCBBA.

STEP 3: REPRESENTATION & OPERATIONS
For foreign manufacturers without an EU entity, appoint an Authorized Representative (AR). The AR serves as the legal liaison with EU Competent Authorities and is responsible for ensuring that the manufacturer’s devices comply with MDR requirements. Appoint Economic Operators (distributors, importers), as needed, and ensure that each party understands their MDR obligations under Articles 11–16.

STEP 4: REGISTRATION & DECLARATION
Register as an actor and separately for your devices in EUDAMED (will become mandatory Q1 2026). Ensure the manufacturer and all relevant Economic Operators (e.g., AR, importer) are also properly registered in the Actor module of EUDAMED. Draft the Declaration of Conformity (DoC), a legally binding document that affirms the device meets the applicable requirements of the MDR. For Class III and implantable devices, prepare a Summary of Safety and Clinical Performance (SSCP) and upload to EUDAMED after NB Technical Documentation Assessment.

STEP 5: COMPILATION
Compile Technical Documentation (TD) in accordance with Annexes II and III of the MDR. The TD must demonstrate conformity with all applicable GSPRs and provide clear, auditable evidence that the device meets EU regulatory expectations.

STEP 6: SUBMISSION
Manufacturers of Class Is, Ir, Im, and Class IIa, IIb, and III devices must submit their TD and engage with an accredited Notified Body (NB) for conformity assessment. The specific type of assessment depends on the device class and selected conformity assessment route (e.g., Annex IX, Annex X, or Annex XI). The NB will assess the QMS, review the TD, and may conduct audits or request additional testing or clinical data. The review process may include expert panels or additional scrutiny per MDR Article 54 for high-risk devices. Class I devices can self-certify (i.e., prepare the full TD, draw up the DoC, and affix the CE mark without involvement from a NB), though documentation must fully comply with MDR and be ready for inspection by Competent Authorities at any time.

STEP 7: CERTIFICATION & FINALIZATION
For Class Is, r, m and Class IIa, IIb and III, the NB issues a QMS certificate and EC Certificate. Once certification is granted, the manufacturer must finalize and sign the DoC, which serves as the legal basis for affixing the CE mark and placing the device on the EU market. The TD must remain complete, version-controlled, and aligned with the final certified configuration and intended purpose of the device.

STEP 8: POST-MARKET RESPONSIBILITIES
Manufacturers must maintain a comprehensive Post-Market Surveillance (PMS) system, including PMS Plans, PMS Reports (Class I), and Periodic Safety Update Reports (Class IIa and higher), as required under Annex III. Post-Market Clinical Follow-up (PMCF) may also be necessary to monitor long-term safety and performance. Vigilance obligations include timely reporting of serious incidents and field safety corrective actions (FSCA). Other responsibilities include EUDAMED data maintenance, certificate renewals, surveillance audits, and ensuring continued compliance with MDR and applicable standards.

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more EU MDR services

EU MDR Classification

CE Marking Approval for Medical Devices

Clinical Evaluation Reports (CER)

Post-market Clinical Follow-up (PMCF)

EU Authorized Representative

EUDAMED Registration

CE Mark Notified Body Search & Selection

Person Responsible for Regulatory Compliance (PRRC)

MDR & IVDR Post-Market Surveillance (PMS)

How We Can Help

Pure Global’s MDR consultants can help you create an MDR compliance strategy from device development to post-market surveillance.

We operate 15 offices across five continents, where we offer local support in the industry’s largest markets.

Frequently
Asked Questions

How do I choose an MDR consultant for my company?

Start by looking for a consultant with a proven track record of successful MDR submissions, especially in your device’s classification and category, though experience with a broad range of device types shows versatility and familiarity with the range of evidence and documentation requirements for different products. Your consultant should be able to explain complex requirements clearly and keep your team aligned throughout the process. Ask about their project management approach, familiarity with digital tools (including AI-based regulatory platforms), and ability to support post-market obligations.

If you're a non-EU manufacturer, prioritize consultants with a global footprint and local EU presence. This ensures they understand regional expectations and can respond quickly to requests from Notified Bodies or Competent Authorities.

Is it worth hiring a consultant if our device is already certified under the MDD?

Absolutely. The MDR introduces significantly stricter requirements that affect nearly every aspect of compliance. Even if your product was previously considered low risk, it may now require Notified Body involvement or additional performance data under MDR. A qualified consultant can perform a thorough gap analysis between your current MDD documentation and what’s required under the MDR. They’ll help you prioritize updates, prepare for your next audit, and avoid disruptions to your EU market access during the transition period. For legacy devices, this guidance is especially valuable to ensure continued CE Marking before MDD certificates expire.

What does a consultant offer that our internal team might miss?

A consultant has the advantage of working across many product types, risk classes, and regulatory pathways, giving them a broader view of how Notified Bodies interpret specific MDR requirements and where common pitfalls occur. Consultants are also up to date on the latest guidance documents, MDCG interpretations, and best practices from across the industry. They can pressure-test your current strategy, identify gaps you may not have considered, and provide templates, checklists, or structured processes to improve quality and consistency. Whether you're preparing for CE Marking or managing post-market activities, a consultant can optimize your timeline, reduce regulatory risk, and strengthen your internal team’s understanding of what success under MDR really looks like.

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Can consulting reduce the cost of MDR compliance?

While hiring a consultant is an upfront investment, it often saves time and money in the long run by avoiding costly delays, failed audits, or rejected submissions. They also help you prioritize efforts so resources are spent efficiently.

Single Process,
Multiple Markets

When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.