European
Compliance Platform
European
Compliance Platform
Getting a medical device onto the EU market under MDR usually means coordinating a testing lab, a Notified Body, and an EU Authorized Representative — separately, in sequence, often with no visibility into who has capacity. ECP routes one structured request to matched providers for each stage, so you're not doing that outreach one email at a time.
Not sure MDR is even the right regulation for your product? Build your full compliance roadmap →
ECP's roadmap tool maps every regulation to the provider types it requires, in the order you need them. For MDR, that route runs through four stages — and a different provider type sits at each one.
CLASSIFY → PROVE → ASSESS → ENTER. Confirm your device class, build the technical evidence, get third-party conformity assessment, then appoint the EU contact point required to place the device on the market.
| Stage | What happens | Provider type | Find one |
|---|---|---|---|
| 1. CLASSIFY | Confirm device class under Annex VIII (I, IIa, IIb, III) and the intended use that drives it. | Regulatory consultant, or your prospective Notified Body during pre-application | Route by device class |
| 2. PROVE | Test against applicable harmonised standards (EMC, electrical safety, biocompatibility, etc.) to build the technical documentation a Notified Body will assess. | Testing Laboratory | Find a Testing Lab → |
| 3. ASSESS | Third-party conformity assessment against Annex IX, X or XI — required for every class above self-declared Class I. | Notified Body | Find a Notified Body → |
| 4. ENTER | Appoint the EU-based legal contact point required under Article 11 before placing the device on the EU market. | EU Authorized Representative | Find an EU Rep → |
Stages 2 and 3 aren't strictly sequential — testing and Notified Body engagement often overlap, and the exact order depends on your conformity assessment route. Stage 4 is a fixed requirement for any non-EU manufacturer, independent of device class: MDR Article 11 doesn't have a self-declaration exemption the way Notified Body involvement does for Class I.
Only Class I devices that are non-sterile, non-measuring, and not reusable surgical instruments can self-certify without one. Everything above that — IIa, IIb, III, and the sterile/measuring/reusable variants of Class I — requires Notified Body involvement, in full or in part.
| Device class | Notified Body | Route |
|---|---|---|
| Class I (non-sterile, non-measuring) | Not required | Self-declaration (Annex IV) |
| Class Is / Im / Ir | Partial | Self-declaration + NB on the specific aspect (sterility, metrology, or reuse) |
| Class IIa | Required | Annex IX (Ch. I + III) or Annex XI Part A |
| Class IIb | Required | Annex IX (Ch. I + III) or Annex X + XI |
| Class III | Required | Annex IX (Ch. I + II) or Annex X + XI Part A |
Full breakdown including implantable devices and the Clinical Evaluation Consultation Procedure: MDR Conformity Assessment Routes by Device Class.
These figures cover the full route — testing, Notified Body assessment, and EU AR appointment — and vary by device class and how much technical documentation already exists:
More detail on what drives these ranges: CE Marking Process: Step-by-Step Guide and How Long Does MDR/IVDR Certification Really Take?
ECP is a neutral routing platform — not a Notified Body, testing lab, consultancy or Authorized Representative itself. You deal directly with whichever provider you choose, on their terms.
Yes. Submit one structured request describing your device, class and current documentation status. ECP routes it to Notified Bodies whose designation scope covers your device, and separately to EU Authorized Representative providers who cover MDR Article 11 — you receive responses from both without submitting separate requests to each.
In most cases, yes. Test reports covering applicable harmonised standards form part of the technical documentation a Notified Body assesses under Annex IX, X or XI. Manufacturers typically complete lab testing, or have it underway, before or during Notified Body engagement — the exact sequencing depends on your device class and chosen conformity assessment route.
No. ECP is a neutral marketplace — it does not perform conformity assessments, testing, or act as an Authorized Representative itself. It routes your structured request to independent Notified Bodies, testing laboratories and EU Authorized Representative providers, who respond directly with their own scope, timeline and terms.
Search is free and unlimited, with no account needed. Your first project is free to send to a small set of matched providers; sending to more providers, or a further project, uses a one-time package — there is no subscription.
Describe your device once and receive proposals from matched testing labs, Notified Bodies and EU Authorized Representatives — no subscription, no account needed to search.
See How ECP Can Help →| Provider type | Needed for | Find a provider |
|---|---|---|
| Testing Laboratory | Stage 2 — harmonised standards testing | Find a Testing Lab → |
| Notified Body | Stage 3 — conformity assessment (IIa, IIb, III) | Find a Notified Body → |
| EU Authorized Representative | Stage 4 — Article 11 EU contact point | Find an EU Rep → |