Free Tool · 2 Minutes

EU MDR Readiness
Self-Assessment

8 yes/no questions across every key compliance area. Get a color-coded gap analysis in under 2 minutes.

EU MDR Class III deadline: May 26, 2026 — 15 days away
Progress Question 1 of 8
Area 1 — Technical Documentation
Do you have a complete Technical Documentation file (TD/TF) for each device you plan to place on the EU market under MDR?
Why it matters: EU MDR Article 10(4) requires manufacturers to maintain Technical Documentation that demonstrates conformity with all applicable requirements. Without it, no Notified Body can issue a certificate — your device cannot legally enter the EU market.
Area 2 — EUDAMED Registration
Is your organization registered in EUDAMED and have you initiated UDI assignment for your devices?
Why it matters: EUDAMED Phase 1 enforcement begins May 28, 2026. Manufacturers must register their organization and devices before placing them on the market. EUDAMED registration is also a prerequisite for Notified Body certificate applications.
Area 3 — ISO 13485 Certification
Do you hold a current ISO 13485:2016 certificate from an accredited certification body?
Why it matters: ISO 13485 certification demonstrates your Quality Management System meets the standard required for EU MDR conformity. Most Notified Bodies require it as a baseline before accepting Technical Documentation review. An expired or MDD-era certificate will not suffice.
Area 4 — Clinical Evaluation
Have you completed a Clinical Evaluation Report (CER) for each device, following MEDDEV 2.7/1 Rev.4 or equivalent MDR-compliant methodology?
Why it matters: EU MDR substantially raises clinical evidence standards vs MDD. A legacy MDD clinical evaluation is rarely sufficient. Class IIa/IIb/III devices require systematic literature review, clinical investigation data, and an updated SSCP (Summary of Safety and Clinical Performance) for Class III and implantable devices.
Area 5 — Post-Market Surveillance
Do you have an active Post-Market Surveillance (PMS) system with a PMS Plan, PMCF Plan, and at least one PSUR or PMS Report produced under MDR requirements?
Why it matters: EU MDR Article 83 requires a proactive, documented PMS system — not just complaint handling. Class III and implantable devices must produce a Periodic Safety Update Report (PSUR) annually. Without an active PMS system, no certificate can be maintained even after initial issuance.
Area 6 — EU Authorised Representative
If you are a non-EU manufacturer, have you appointed a registered EU Authorised Representative (EU AR) with a written mandate?
Why it matters: EU MDR Article 11 requires any manufacturer outside the EU/EEA to designate an EU AR before placing a device on the market. The EU AR is jointly liable with the manufacturer and must be registered in EUDAMED. Without one, your products cannot legally be sold in Europe.
Area 7 — Unique Device Identification (UDI)
Have you assigned UDI-DI and UDI-PI codes via an accredited issuing entity (GS1, HIBCC, or ICCBBA) and labelled your devices accordingly?
Why it matters: UDI is mandatory under EU MDR Annex VI. Class III and implantable devices required UDI labelling by May 26, 2021; Class IIa/IIb by May 26, 2023. For devices still under MDD certificates transitioning to MDR, UDI assignment and EUDAMED upload must be completed before any new MDR certificate is issued.
Area 8 — Declaration of Conformity
Have you prepared an EU MDR-compliant Declaration of Conformity (DoC) for each device, referencing the correct regulation (EU 2017/745) and all applicable Annexes?
Why it matters: The DoC is the manufacturer's legal statement that a device meets all applicable MDR requirements. An MDD-era DoC referencing Directive 93/42/EEC is invalid under MDR. The document must reference EU 2017/745, list all applicable conformity assessment annexes, and be signed by the person responsible for regulatory compliance.
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