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CE Marking Consultants for Medical Devices

CE marking consultants help manufacturers certify a medical device for the EU market under the Medical Device Regulation (EU) 2017/745 (MDR). I3CGLOBAL’s CE marking consulting services prepare the technical file and clinical evaluation, manage the notified body submission and support you until the CE certificate is issued.

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Listen to this guide

MDR CE marking explained · 3 min

Audio overview recorded in 2024. Where it differs, follow the written guide below.

The basics

What Do CE Marking Consultants Do?

CE marking consultants plan and prepare everything a manufacturer needs to show that a medical device meets the EU MDR. There is no EU agency that grants CE marking. The manufacturer demonstrates conformity, and for most devices a notified body assesses the quality system and technical documentation and issues a certificate. Medical device CE marking consultants make sure that evidence is complete, consistent and ready for review.

In practice, a CE marking project has six parts: classification, the conformity route, the quality system, the technical documentation, the notified body assessment and the declaration of conformity. Our MDR CE marking approval flowchart shows the full sequence step by step.

When to bring in CE marking consultants: the best time is before design freeze, when the intended purpose, claims and test plan can still change at low cost. Many manufacturers also call us later, when a notified body has raised non-conformities, when a legacy MDD certificate is close to expiry, or when the internal regulatory lead has left. A short gap analysis shows how far the current file is from what the notified body expects.

CE marking consultants process for medical devices under the MDR: classification, QMS, evidence, technical file, notified body review and CE certificate

What the MDR asks for

Classes I, Is, Im, Ir, IIa, IIb and III under 22 rules in Annex VIII
Technical documentation in the structure of Annexes II and III
Clinical evaluation under Article 61 and Annex XIV
Post-market surveillance, UDI and EUDAMED registration

When a notified body is involved

Class I: self-declared, no notified body
Class Is, Im and Ir: only for sterility, measuring or reuse
Class IIa and IIb: QMS audit and sampled file review
Class III: QMS audit and review of every device

Services

CE Marking Consulting Services for Medical Devices

Our CE marking consulting services can cover one gap or the full project. Most clients choose a turnkey scope, where one team prepares the documents, coordinates testing and supports the notified body review. For an overview of our CE marking services for medical devices, see the main service page.

1. Classification and strategy

Classification under the 22 rules of Annex VIII, the conformity route and a realistic plan. See medical device classification.

2. Technical documentation

Files in the structure of Annexes II and III, with the GSPR checklist and full traceability. See technical file.

3. Clinical evaluation

Clinical evaluation plans and reports under Article 61 and Annex XIV, plus PMCF. See EU MDR clinical evaluation.

4. Testing coordination

Planning and review of biocompatibility, electrical safety and other verification testing.

5. Risk and usability

Risk management to ISO 14971 and usability engineering files to IEC 62366-1.

6. Quality system

ISO 13485 systems with MDR-specific procedures. See our ISO 13485 consultants.

7. Notified body submission

Notified body selection, application, audit preparation and evidence-based answers to every question.

8. EU representative and PRRC

Article 11 EU authorised representative services and PRRC support from Germany and Portugal.

9. Labels, UDI and EUDAMED

Labels and IFUs, UDI assignment and EUDAMED registration.

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MDD to MDR

What Changed From the MDD to the MDR?

The MDR replaced the Medical Device Directive 93/42/EEC and the Active Implantable Medical Device Directive 90/385/EEC on 26 May 2021. The rules for CE marking became stricter in almost every area, which is why many manufacturers now work with MDR CE marking consultants even for devices they certified years ago.

Area	Under the MDD	Under the MDR
Legal form	Directive, transposed into national law	Regulation, applies directly in every Member State
Classification	18 rules	22 rules, with stricter rules for software, substances and nanomaterials
Clinical evidence	Equivalence widely accepted	Equivalence needs access to the other device’s data, and more clinical investigations for implants and class III
Post-market	Vigilance and general PMS	PMS plan, PMCF, PMS report or PSUR, and stricter vigilance timelines
Traceability	No EU-wide UDI system	UDI on labels and registration in EUDAMED
Roles	No PRRC requirement	PRRC under Article 15, and defined duties for importers and distributors
Scope	Medical devices only	Also covers Annex XVI products without a medical purpose

Because of these changes, most MDD files need more than a template update. A gap analysis shows which parts of your existing technical documentation can be reused and which must be rebuilt.

Legacy devices

What Happens to MDD Certificates?

Devices certified under the MDD or AIMDD can stay on the market for a limited time, but only if the manufacturer met strict conditions set by Regulation (EU) 2023/607. After these dates, an MDR certificate is needed to keep selling the device in the EU.

Device group	Legacy end date	Conditions
Class III and class IIb implantable, apart from listed exceptions such as sutures, staples and screws	31 December 2027	MDR QMS and notified body application by 26 May 2024, written agreement by 26 September 2024
Other class IIb, class IIa and class I devices that need a notified body under the MDR	31 December 2028	Same conditions, plus no significant change and no unacceptable risk

Good to know: the dates to qualify for the extension have passed. If a legacy device did not meet the conditions, it needs an MDR certificate before it can be placed on the market. For devices that did qualify, the notified body still has to finish its review before the end date, so keep answering its questions quickly.

How we work

Our 6-Step CE Certification Process

As medical device CE certification consultants, we run every project through the same six steps. Each step has a clear deliverable, so you can see progress and the notified body sees a consistent file.

Gap analysis and planWe review your device, intended purpose and existing documents and agree the class, route, scope and timeline.
Quality system and rolesWe set up or update your ISO 13485 system, the PRRC role and, for non-EU manufacturers, the EU authorised representative.
Evidence and testingWe plan verification testing and write the clinical evaluation, the risk file and usability documents.
Technical documentationWe compile the technical file, GSPR checklist, labels, IFU, PMS plan and, where needed, the SSCP.
Notified body assessmentWe submit the application, prepare you for the QMS audit and answer technical documentation questions with evidence.
Certificate and market accessAfter certification you sign the EU declaration of conformity, affix the CE mark and register in EUDAMED. We then support PMS and surveillance audits.

For the stages and typical durations in more detail, read our CE marking process and timeline.

Working on an in vitro diagnostic? IVDs are CE marked under a separate regulation, the IVDR (EU) 2017/746, with different classes, performance evaluation and deadlines. See our IVDR consultants page.

Specialist devices

Which Devices Need Specialist CE Marking Support?

Some devices raise extra questions during CE marking. Medical device CE marking consultants with experience in these product types can prevent long review rounds. These are the categories where we most often add specialist input to a medical device CE certification project.

Medical device software

Rule 11 often moves software to class IIa or higher. Files need IEC 62304 life cycle evidence and cybersecurity. See software CE marking and cybersecurity consulting.

Devices with a medicinal substance

Under Rule 14 these are class III, and the notified body must consult a medicines authority on the ancillary substance.

Substance-based devices

Rule 21 applies to devices made of substances that are absorbed or dispersed in the body. See medical devices composed of substances.

Reusable surgical instruments

Class Ir devices need validated cleaning, disinfection and sterilisation instructions. See class Ir instruments.

Products without a medical purpose

Annex XVI products such as IPL and laser equipment must meet common specifications. See IPL and laser devices.

Active and implantable devices

These need electrical safety, EMC and often long-term clinical data, and class III implants need an SSCP published in EUDAMED.

Notified bodies

How Do CE Marking Regulatory Consultants Work With Notified Bodies?

For most devices, CE marking depends on a notified body. CE marking regulatory consultants help you choose the right one, prepare a complete application and keep the review moving. Only notified bodies designated for your device codes can certify your device, so we check each candidate in the Commission’s NANDO database and in our notified bodies list.

Under the usual Annex IX route, the notified body audits your quality management system and reviews the technical documentation, either for every device or for representative devices, depending on the class. Certificates are valid for up to five years. After that, the notified body carries out surveillance audits at least every 12 months and unannounced audits at least once every five years.

What we prepare

A shortlist of designated notified bodies with capacity
The application and supporting documents
Audit readiness checks and mock audits
Evidence-based answers to every non-conformity

Common reasons for delay

Clinical evidence that does not support all claims
Weak equivalence or literature justifications
Gaps between the GSPR checklist and the evidence
Inconsistent labels, IFU and risk documents

Notified body fees are separate from consulting fees and vary by notified body and device. See our guide to notified body fees.

Time and cost

How Long Does CE Certification Take and What Does It Cost?

In the European Commission’s 20th notified bodies survey, with data to 28 February 2026, the most commonly reported time from signed agreement to MDR certificate was 13 to 18 months. Preparation before the application often adds several months, depending on how much evidence already exists.

Cost driver	Why it matters
Device class	Higher classes need more clinical evidence and a deeper notified body review
Existing documentation	A complete MDD file needs updating, not rewriting
Clinical or performance data	New clinical investigations are the largest single cost
Testing needs	Biocompatibility, electrical safety, software and sterilisation testing vary by device
Number of devices	Device families can share one technical file and one clinical evaluation
Notified body fees	Charged separately by the notified body for audits, reviews and certificates

Read our CE certification cost guide for the main cost items, or request a quote for your device.

Outside the EU

EU CE Marking Consultants for Manufacturers Outside the EU

Manufacturers outside the EU follow the same CE marking route, with a few extra duties. As EU CE marking consultants with offices inside and outside Europe, we handle these roles for you:

An EU authorised representative under Article 11 of the MDR, with a written mandate
A person responsible for regulatory compliance, either employed or permanently available for small companies
Importer checks of the CE marking, declaration of conformity, labels and EUDAMED registration
Labels and IFUs in the languages required by each Member State
Actor and device registration in EUDAMED, which became mandatory on 28 May 2026

For UK market access after CE marking, see our UKCA consultants and our MDR CE marking service in London.

Why I3CGLOBAL

Why Choose I3CGLOBAL as Your CE Marking Consultants?

The right CE marking consultants shorten review rounds because the file is right the first time. This is what I3CGLOBAL brings to each project.

More than 300 CE certifications supported for medical device manufacturers
Full-time in-house consultants; we do not outsource work to freelance individuals
ISO/IEC 27001 certified information security for client documents
Offices in India, Germany, Portugal, the UK, the USA, Malaysia and Vietnam
EU authorised representative offices in Germany and Portugal
MDR projects for software, active, sterile, reusable and implantable devices

Need help with the wider regulation rather than one certificate? Our EU MDR consultants support QMS, post-market surveillance and ongoing MDR compliance.

Work with I3CGLOBAL

Talk to Our CE Marking Consultants

Tell us about your device, its class and your target date. We will propose a scope, a timeline and a quote for your MDR CE marking project.

MDR technical documentation and GSPR checklist
Clinical evaluation and PMCF
Notified body submission and support

Request a CE marking proposal

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

Request an MDR Quote Contact Us

FAQs

CE Marking Consultants: Frequently Asked Questions

How long does CE marking take under the MDR?

Most MDR projects take 13 to 18 months from a signed notified body agreement to certificate, based on the Commission’s 20th notified bodies survey. CE marking consultants cannot shorten the notified body’s own review time, but a complete and consistent file reduces the number of review rounds.

How do CE marking consultants show compliance with the GSPR?

We build a GSPR checklist that lists every requirement in Annex I, states whether it applies and links it to the evidence: standards, test reports, risk controls, clinical data and labelling. See our GSPR guide.

Can we use MDD data for MDR compliance?

Yes, in many cases. Existing test reports, clinical data and post-market data can support the MDR file if they are still valid and relevant. Gaps usually remain in clinical evidence, PMS documentation and labelling, which a gap analysis identifies early.

Do you prepare the technical documentation or only guide us?

We prepare it. Our consultants write the technical documentation, clinical evaluation, risk file and PMS documents using your design and test data. Your team reviews and approves them as the legal manufacturer.

How do you protect confidential information?

I3CGLOBAL is ISO/IEC 27001 certified for information security. Our CE marking consultants are full-time employees, and we do not pass client work to freelance individuals.

Do you offer a turnkey CE marking service?

Yes. A turnkey scope can include documentation, coordination of biocompatibility and electrical safety testing, clinical evaluation, risk analysis, usability, EU authorised representative services and EUDAMED registration.

Do class I medical devices need a notified body?

Class I devices that are not sterile, do not have a measuring function and are not reusable surgical instruments are self-declared, so no notified body is needed. Class Is, Im and Ir devices need a notified body for the sterile, measuring or reuse aspects only.

What are the post-market obligations under the MDR?

After CE marking you must run post-market surveillance, report serious incidents, update the clinical evaluation and prepare a PMS report or PSUR. Notified bodies check these at surveillance audits at least once a year.