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EU MDR Consultants for Medical Device Manufacturers

EU MDR consultants help medical device manufacturers meet Regulation (EU) 2017/745, from classification and technical documentation to notified body audits, post-market surveillance and EUDAMED. I3CGLOBAL’s EU MDR consulting services give you one multidisciplinary regulatory, clinical and quality team for the whole MDR life cycle.

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EU MDR consultants explained · 2 min
Short audio overview. Where it differs, follow the written guide below.
The basics

What Do EU MDR Consultants Do?

EU MDR consultants are regulatory specialists who plan and prepare the evidence a manufacturer needs to place a medical device on the EU market under Regulation (EU) 2017/745. The MDR has applied since 26 May 2021 and replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). It asks for more clinical evidence, stricter post-market surveillance, unique device identification and registration in EUDAMED.

A good EU MDR consultant does not just review documents. The work covers strategy, writing and defending the file: confirming the class under Annex VIII, choosing the conformity assessment route under Article 52, building the technical documentation in the structure of Annexes II and III, writing the clinical evaluation report, and answering notified body questions until the certificate is issued.

EU MDR consultants roadmap: gap analysis, classification, technical documentation, notified body audit and post-market compliance

What I3CGLOBAL takes on

  • Regulatory strategy, classification and conformity route
  • Technical documentation, GSPR checklist and risk file
  • Clinical evaluation plan and report, PMCF and PSUR
  • Notified body application, audit support and replies

What stays with your team

  • Design, manufacturing and test data for the device
  • Day-to-day running of your quality system
  • Final review and sign-off as the legal manufacturer
  • Decisions on markets, claims and product changes
Who it is for

Who Needs an EU MDR Consultant?

Any manufacturer that places devices on the EU market must meet the MDR, wherever it is based. An EU MDR consultant is most useful when the internal team lacks MDR experience, is short of time, or faces a notified body deadline. These are the situations we see most often.

First-time CE marking

Start-ups and new market entrants that need a full plan, from intended purpose to certificate, without hiring a regulatory department first.

MDD legacy devices

Manufacturers moving legacy devices to MDR certificates before the transition periods end on 31 December 2027 or 2028.

Non-EU manufacturers

Companies in India, the USA, the UK and Asia that also need an EU authorised representative and a PRRC.

Class I self-declaration

Class I manufacturers that self-declare but still need a compliant technical file, PMS report and EUDAMED registration.

Software and active devices

Medical device software and active devices that often move to a higher class under Rule 11 and need software CE marking support.

Notified body findings

Teams with open non-conformities or a large list of technical documentation questions that must be answered quickly and with evidence.

Services

EU MDR Consulting Services We Offer

Our EU MDR consulting services cover the full regulation, so you can use us for one gap or for the whole project. Each service below is delivered by regulatory, clinical or quality specialists who work on MDR files every day.

1. MDR gap analysis

We compare your current file or MDD documentation against the MDR and give you a prioritised action list. See our MDR gap analysis checklist.

2. Classification and route

A written rationale under the 22 rules of Annex VIII and the matching Article 52 route. Read our medical device classification guide.

3. Technical documentation

Complete files in the structure of Annexes II and III, including the GSPR checklist. See medical device technical file.

4. Clinical evaluation

Clinical evaluation plans and reports under Article 61 and Annex XIV, written by experienced EU MDR clinical evaluation writers.

5. Risk management

Risk management files aligned with ISO 14971 and linked to design, labelling and post-market data. See medical device risk management.

6. QMS and ISO 13485

Quality systems that cover Article 10(9), built on ISO 13485 with MDR-specific procedures. See our ISO 13485 consultants.

7. PMS, PMCF and PSUR

Post-market surveillance plans, PMCF plans and reports, and PSURs under Articles 83 to 86. See PMS plan.

8. PRRC support

Help to meet Article 15, including a person responsible for regulatory compliance through our EU offices where needed.

9. EU authorised representative

Article 11 authorised representative services from our offices in Germany and Portugal for manufacturers outside the EU.

10. EUDAMED and UDI

Actor and device registration in EUDAMED, Basic UDI-DI assignment and UDI labelling.

11. Notified body support

Choosing a designated notified body, preparing the application, audit readiness and answers to every review question.

12. MDR CE marking

End-to-end MDR CE marking projects with our MDR CE marking consultants, from file to certificate and declaration of conformity.

Good to know: for in vitro diagnostic devices under Regulation (EU) 2017/746, see our IVDR consultants. The IVDR has different classes, performance evaluation rules and transition dates.

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How we work

How Does Our MDR Compliance Consulting Work?

Our MDR compliance consulting follows six steps. Each step ends with a clear deliverable, so you always know what is finished, what is open and what the notified body will see.

  1. Kick-off and gap analysisWe review your device, intended purpose and existing documents, then list every MDR gap by risk and effort.
  2. Regulatory strategyWe confirm the class, the conformity route, the clinical evidence strategy and a realistic timeline with milestones.
  3. Build the documentationOur writers prepare or update the technical file, GSPR checklist, risk file, clinical evaluation, labels and PMS documents.
  4. Internal reviewA second reviewer checks consistency across the IFU, clinical evaluation and risk file before anything goes to the notified body.
  5. Notified body assessmentWe support the QMS audit and technical documentation review and draft evidence-based answers to every non-conformity.
  6. Certificate and maintenanceAfter certification we keep the file current with PMS, PSUR, PMCF, vigilance and change control.

For the full regulatory sequence, see our MDR CE marking approval process flowchart and the CE marking process and timeline.

Deliverables

What Documents Do EU MDR Consultants Prepare?

Most of an MDR project is documentation. The notified body reviews these documents, and the competent authority can ask for them at any time. The table shows the core documents our medical device MDR consultants prepare or update, and where each one sits in the regulation.

Document MDR reference Why it matters
Device description and intended purpose Annex II, section 1 Sets the scope for classification, clinical evidence and labelling claims
Classification rationale Annex VIII Shows which rule applies and why, and fixes the conformity route
GSPR checklist Annex I Links every safety and performance requirement to evidence or a justified exclusion
Risk management file Annex I, sections 1 to 9 Records hazards, risk controls and the overall benefit-risk conclusion
Clinical evaluation plan and report Article 61 and Annex XIV Proves safety, performance and clinical benefit with sufficient clinical data
Labels and instructions for use Annex I, Chapter III Must match the intended purpose, warnings and claims in the clinical evaluation
PMS plan, PMCF plan and PSUR Annex III and Articles 84 to 86 Shows how real-world data will be collected and fed back into the file
SSCP Article 32 Required for implantable and class III devices and published in EUDAMED
EU declaration of conformity Article 19 and Annex IV The manufacturer’s legal statement that the device meets the MDR

Consistency is the most common problem we find in a gap analysis. The same intended purpose, indications, contraindications and warnings must appear in the IFU, the clinical evaluation, the risk file and the summary of safety and clinical performance. Our reviewers check this before submission, because inconsistent files are a frequent reason for repeated notified body review rounds.

Key dates

Which MDR Deadlines Should Manufacturers Plan For?

Several MDR dates fall between now and the end of 2028. Regulation (EU) 2023/607 extended the transition for legacy devices, and EUDAMED became mandatory in 2026. Plan your EU MDR consulting work around these dates.

Date What applies Who it affects
28 May 2026 First four EUDAMED modules mandatory: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance All manufacturers, authorised representatives and importers
28 November 2026 Deadline to register devices placed on the market before 28 May 2026 that are still made available Manufacturers with devices already on the EU market
31 December 2027 End of the transition period for class III and class IIb implantable legacy devices, apart from listed exceptions such as sutures, staples and screws MDD and AIMDD certificate holders
31 December 2028 End of the transition period for other class IIb, class IIa and class I sterile, measuring or up-classified legacy devices MDD certificate holders and up-classified class I devices

The legacy extension only applies if the manufacturer had an MDR quality management system by 26 May 2024, applied to a notified body by 26 May 2024 and signed a written agreement by 26 September 2024. The device must also stay compliant with the old directive and must not change significantly.

Good to know: in December 2025 the European Commission proposed a targeted revision of the MDR and IVDR, COM(2025) 1023. At the time of this update it had not been adopted, so the MDR applies as written. We track the file and update clients when the text changes.

After the certificate

What Does EU MDR Compliance Involve After CE Marking?

CE marking is not the end of an MDR project. Most of the work after certification is post-market, and notified bodies check it at every surveillance audit. Our EU MDR compliance services keep these obligations running for you.

Obligation MDR reference What it means in practice
Post-market surveillance Articles 83 and 84 A PMS system and plan for every device, proportionate to its risk
PMS report or PSUR Articles 85 and 86 PMS report for class I; PSUR at least every two years for class IIa and every year for class IIb and III
Vigilance Article 87 Serious incidents reported no later than 15 days after awareness, with shorter limits for deaths and serious public health threats
PMCF Annex XIV, Part B A PMCF plan and report, or a justification for why PMCF is not needed
Supply interruption Article 10a Inform the competent authority at least six months before stopping supply of certain devices
Change control Annex IX, section 4.10 Tell the notified body about planned substantial changes before they are made

We combine these tasks with vigilance support, PSUR writing and annual updates of the clinical evaluation, so your file stays ready for unannounced audits.

Why I3CGLOBAL

Why Choose I3CGLOBAL as Your EU MDR Consultant?

Hiring and training an in-house MDR team takes time and budget. Working with EU MDR regulatory consultants gives you a full team from the first week, and you pay only for the work your devices need.

  • More than 300 CE certifications supported for medical device manufacturers
  • Regulatory, clinical, biocompatibility and quality specialists in one team
  • Offices in India, Germany, Portugal, the UK, the USA, Malaysia and Vietnam
  • EU authorised representative offices in Germany and Portugal, with PRRC support
  • Experience with active, implantable, software, sterile and reusable devices
  • Confidentiality agreements and controlled access to all client documents

Building an in-house MDR team

  • Months to recruit and train specialists
  • Fixed salaries even when the workload drops
  • Gaps in clinical or biocompatibility expertise

Working with EU MDR consultants

  • A ready team that starts with a gap analysis
  • Costs linked to scope and deliverables
  • Specialists for each part of the technical file
Global markets

Regulatory Consulting Beyond the EU

Many medical device MDR consultants work only on Europe. Our medical device regulatory consulting team also covers the other major markets, so one technical file can support several submissions.

United Kingdom

UKCA marking and MHRA registration with our UKCA consultants and UK responsible person services.

United States

510(k), De Novo and establishment registration with our US FDA consultants.

Quality systems

ISO 13485 certification, MDSAP and FDA QMSR readiness for global audits.

In vitro diagnostics

IVDR classification, performance evaluation and technical files with our IVDR consultants.

Work with I3CGLOBAL

Work With Experienced EU MDR Consultants

Tell us about your device and where your file stands today. Our EU MDR consultants will propose a scope, a timeline and a quote.

  • MDR gap analysis and regulatory strategy
  • Technical documentation and clinical evaluation
  • Notified body, PMS and EUDAMED support

Request an EU MDR proposal

Share your device description, class and target date, and we will come back with a proposal.

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FAQs

EU MDR Consultants: Frequently Asked Questions

What does an EU MDR consultant do?

An EU MDR consultant helps a manufacturer meet Regulation (EU) 2017/745. The work includes classification, the conformity assessment route, technical documentation, clinical evaluation, risk management, post-market surveillance, EUDAMED registration and support during the notified body assessment.

Do class I medical devices need an EU MDR consultant?

Class I devices that are not sterile, measuring or reusable surgical instruments do not need a notified body. The manufacturer still needs a full technical file, a clinical evaluation, a PMS report, a PRRC and EUDAMED registration. Many class I manufacturers use an EU MDR consultant to prepare these documents correctly the first time.

How much do EU MDR consulting services cost?

The cost depends on the device class, the state of the existing documentation and the services you need. A gap analysis is the best starting point for an accurate quote. See our CE certification cost guide for typical cost drivers.

How long does MDR certification take?

In the European Commission’s 20th notified bodies survey, with data to 28 February 2026, the most commonly reported time from signed agreement to certificate was 13 to 18 months. Well-prepared files and fast answers to notified body questions help keep a project at the shorter end.

Can I3CGLOBAL support the PRRC requirement?

Yes. Article 15 requires every manufacturer to have a person responsible for regulatory compliance. Micro and small enterprises may have one permanently and continuously at their disposal instead of employing one. Our EU authorised representative offices in Germany and Portugal can support this requirement.

What happens to devices with an MDD certificate?

Under Regulation (EU) 2023/607, legacy devices that met the conditions can stay on the market until 31 December 2027 or 31 December 2028, depending on the class. The manufacturer must still move them to MDR certificates before those dates.

Is the EU MDR being simplified?

In December 2025 the European Commission proposed a targeted revision of the MDR and IVDR. At the time of this update the proposal had not been adopted, so the current MDR requirements still apply in full.

Do you work with manufacturers outside the EU?

Yes. Most of our clients are based outside the EU, including India, the USA, the UK and Asia. We provide the EU authorised representative, PRRC support and the full MDR file, so non-EU manufacturers can reach the EU market with one partner.