CE marking under Regulation (EU) 2017/745

Your CE mark, built on the ISO 13485 system you already run.

The MDR's quality-system half is ISO 13485. We build the other half with you: classification, technical file, clinical evidence, post-market surveillance and the Declaration of Conformity, device by device, in a system your own team runs.

Take the free CE readiness checkBook a walkthrough

Five minutes. Nothing you enter is stored.

38 days
Legacy devices in EUDAMED
Devices already on the market before 28 May 2026 and still being sold must be registered in EUDAMED.
127 days
Notified body time limits apply
Maximum timelines for notified body reviews: application 30 days, QMS audit 120 days, technical documentation 90 days, decision 20 days. A complete application is what gets you to the front.
436 days
Legacy class III and implantable IIb
End of the transition for devices still on MDD/AIMDD certificates: class III and implantable class IIb (with exceptions). Only if the MDR application was lodged by 26 May 2024 and signed by 26 September 2024.

From your device to the CE mark

  1. Step 1

    Classify

    Answer plain questions; the 22 Annex VIII rules give your class, the rule that decided it and your conformity route.

  2. Step 2

    Build the technical file

    A checklist built for your class: Annex II and III documentation, GSPRs, risk, verification, clinical evaluation, PMS.

  3. Step 3

    Choose a notified body

    For anything above plain class I. Arrive with a complete file: from February 2027 they must work to fixed time limits.

  4. Step 4

    Sign the Declaration

    A draft EU Declaration of Conformity, pre-filled from your device data, with every gap marked.

  5. Step 5

    Affix the CE mark

    With your notified body's number where one was involved. Then keep it: PMS, PSURs and vigilance on a schedule.

Free CE readiness check

Classify your device, then see how close you are to a CE mark and what is still open. Runs in your browser.

Part 1 · What class is your device?

1. What kind of device is it?
2. About how it is used
3. Special features (tick any that apply)
Indicative EU MDR class
Class IRule 1 · Self-declared

Non-invasive device not covered by another rule.

Route: Self-declaration: draw up the technical documentation (Annexes II and III) and the EU Declaration of Conformity. No notified body (Art 52(7)).

  • Indicative only. Confirm the class with your notified body; MDCG 2021-24 is the Commission's classification guidance.

Part 2 · How close are you to the CE mark?

14 questions for a class I device made outside the EU.

  • Quality management system in place
    Art 10(9); Annex IX §2.2
  • Person responsible for regulatory compliance (PRRC) named
    Art 15; MDCG 2019-7
  • EU authorised representative appointed
    Art 11; MDCG 2022-16
  • Registered in EUDAMED with a Single Registration Number (SRN)
    Art 31; Commission Decision on EUDAMED functionality
  • Basic UDI-DI and UDI-DI assigned
    Art 27, Annex VI part C
  • General safety and performance requirements (GSPR) checklist
    Annex II §4; Annex I
  • Benefit-risk analysis and risk management
    Annex II §5; Annex I §1–9
  • Pre-clinical verification and validation
    Annex II §6.1(a)–(b)
  • Labels and instructions for use
    Annex II §2; Annex I §23; Art 10(11)
  • Clinical evaluation report (CER)
    Art 61; Annex XIV part A
  • Post-market surveillance system and plan
    Arts 83–84; Annex III §1.1
  • Post-market surveillance report
    Art 85
  • Vigilance procedure with the MDR time limits
    Arts 87, 89; MDCG 2023-3
  • EU Declaration of Conformity
    Art 19; Annex IV
0/14 answered. Unanswered counts as no.

What you get in the platform

Bring the pack you already have

Upload your technical file, Declaration of Conformity, CER or PMS plan. We map it to the MDR checklist, show what is missing, and flag what is out of date, such as files still written to the old MDD.

One CE mark, many markets

Pick where you want to sell: Switzerland, the UK, Turkey, Saudi Arabia, the UAE, Australia, Singapore and more. Each market adds its local steps to the device's checklist.

Your ISO 13485 work counts

Quality-system items pre-fill from your ISO 13485 gap analysis. A US maker under the FDA's QMSR runs one QMS for both markets.

Ready for the notified body, as a number

Each device shows how much of its file is done. Only items marked done count, and nothing is quietly marked not applicable: that needs a reason.

Evidence linked, not described

Link each item to the controlled document that proves it, and export the technical file index for your notified body or reviewer.

Dates that don't slip

EUDAMED deadlines, the end of the MDR transition and the vigilance clocks (2, 10 and 15 days) in front of you, not in a PDF.

Where a CE mark takes you

The CE mark is a passport well beyond the EU. Pick your markets and their local steps join your checklist.

CE mark is the market access

  • European Union (27 countries) · National competent authorities
  • Norway, Iceland, Liechtenstein · National competent authorities
  • Northern Ireland · MHRA
  • Turkey · TITCK

CE mark accepted, plus local steps

  • Switzerland · Swissmedic
  • Great Britain · MHRA

CE approval fast-tracks local registration

  • Saudi Arabia · SFDA
  • United Arab Emirates · EDE
  • Australia · TGA
  • New Zealand · Medsafe
  • Singapore · HSA
  • Malaysia · MDA
  • Israel · AMAR (Ministry of Health)

Summary as of October 2026. Local rules change; confirm with your local representative.

Pricing

On top of your ISO 13485 plan (US · South Africa, in rand). Compare: consultants and notified body fees for one class IIa device typically run €40,000–€150,000 (published third-party estimates, 2026).

Add-on to any plan

CE Mark & Global Markets

Get the CE mark, then keep it, in every market it opens.

$350 / month
3 devices included · $75 / month per extra device
  • ✓Up to 3 devices, each classified under MDR Annex VIII
  • ✓Technical-file checklist with a ready-for-the-notified-body score
  • ✓Upload and review of your existing CE / MDR pack
  • ✓Draft EU Declaration of Conformity and technical file index
  • ✓Every target market's local steps: Switzerland, UK, Turkey, Saudi Arabia, UAE, Australia and more
  • ✓PSUR, PMS and vigilance deadlines that keep the CE mark current
Add it to your plan
One-off

CE Pack Review

Already have a CE or MDR pack? Find out where it stands.

$750 once
Per device
  • ✓Your existing CE / MDR pack reviewed against the MDR checklist for your device class
  • ✓What is covered, what is missing, and what is out of date (MDD, old standards)
  • ✓Your ready-for-the-notified-body score and a prioritised fix list
  • ✓A 30-minute call to walk through the findings
Request a CE Pack Review

We are not registered for VAT, so no VAT is added to these prices. Notified body, authorised representative and testing fees are charged by those parties, not by us. We help you prepare; certification decisions belong to your notified body.

Questions

Are you a notified body?
No, and we can't be: notified bodies must be independent of the companies they certify, so they may not also help them prepare. We help you build a complete, well-evidenced file. Your notified body assesses it and decides.
How accurate is the classification?
It applies the MDR's Annex VIII rules to your answers and shows which rule decided the class. It is indicative: borderline devices, accessories and software that drives hardware need your regulatory lead and your notified body to confirm. MDCG 2021-24 is the Commission's guidance.
We are outside the EU. What changes?
You need an EU authorised representative under a written mandate (Art 11), and your importer has checks to make (Art 13). Both appear on your checklist automatically, and the Declaration of Conformity leaves a marked space for your representative.
What about the proposed MDR simplification?
The Commission proposed changes in December 2025 (lower fees for small companies, no fixed five-year certificate expiry, longer PSUR intervals). It is not law yet. The rules in the platform are kept as configuration, so they change when the law does.