ECP for MDR: One Request, the Right Providers, in Order

The MDR route, in four stages

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.

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.

Does your device need a Notified Body?

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.

Typical timeline and cost

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:

• Class IIa: 8–18 months, €30,000–€80,000
• Class IIb–III: 18–48 months, €80,000–€300,000+

More detail on what drives these ranges: CE Marking Process: Step-by-Step Guide and How Long Does MDR/IVDR Certification Really Take?

How ECP matches your MDR request

1. Describe your device — device type, classification (or your best estimate), applicable GMDN/MDD codes, target EU markets, and current documentation and testing status. Takes about 5 minutes.
2. ECP routes your request — to Notified Bodies whose designation scope covers your device and classification, and to testing labs covering your applicable standards, based on current availability.
3. Receive proposals directly — providers respond with scope confirmation, timeline and pricing. You compare and decide; ECP takes no commission and adds no markup.

Frequently Asked Questions

Find the right provider directly

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 →

Related guides

• MDR Conformity Assessment Routes by Device Class
• EU Authorized Representative Under MDR — Complete Guide
• How to Select a Notified Body for CE Marking
• Technical Documentation for CE Marking
• ISO 13485 vs MDR QMS: What's the Difference?
• The EU Compliance Marketplace — full overview