What is the EU MDR and who must comply?
Regulation (EU) 2017/745 · MDR Article 2, 4, 10, 15
The short answer
The EU Medical Device Regulation (EU MDR), formally Regulation (EU) 2017/745, is the binding EU law that sets out safety, performance, and quality requirements for medical devices placed or made available on the EU market. Compliance is mandatory — not optional — for any manufacturer, importer, authorised representative, or distributor involved in the EU medical device supply chain.
What the MDR replaced — and why it matters
The MDR replaced two older directives:
- MDD (93/42/EEC) — Medical Device Directive, in force since 1993
- AIMDD (90/385/EEC) — Active Implantable Medical Devices Directive
Directives required EU member states to pass national laws implementing the rules. The MDR is a Regulation — it applies directly in all 27 EU member states without national transposition. This removes the patchwork of national interpretations that existed under the MDD.
The Commission's stated goals were to strengthen pre-market scrutiny, increase post-market oversight, improve traceability, and expand scope to cover device categories previously unregulated or under-regulated.
Who must comply with EU MDR?
| Role | MDR obligations |
|---|---|
| Manufacturer | Design, develop, manufacture to MDR requirements; maintain QMS; produce technical documentation; appoint PRRC; post-market surveillance |
| Authorised Representative (AR) | Required for manufacturers outside the EU; registered in EUDAMED; assumes regulatory responsibility alongside manufacturer |
| Importer | Verify CE marking, labelling, and manufacturer registration before placing on market |
| Distributor | Verify CE marking before making available; maintain records; cooperate with surveillance |
| Notified Body | Conduct conformity assessment for Class I* / IIa / IIb / III devices |
If you manufacture, import, or distribute a medical device in the EU, MDR applies to you.
What counts as a medical device under MDR?
Article 2(1) defines a medical device as any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by its manufacturer to be used for:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation, or compensation of injury or disability
- Investigation, replacement, or modification of anatomy or of a physiological or pathological process or state
- Providing information by means of in vitro examination of specimens from the human body
Software is explicitly named in Article 2(1). Software that meets this definition is a medical device — regardless of whether it runs on hardware, in the cloud, or as a standalone app. Annex XVI also brings certain non-medical purpose devices (e.g. aesthetic devices) into scope.
Key MDR obligations every manufacturer must meet
- Device classification — Determine Class I, IIa, IIb, or III using Annex VIII
- Conformity assessment — Follow the appropriate route per Annex IX, X, or XI
- Quality Management System — Implement a QMS aligned with ISO 13485
- Technical Documentation — Annex II and Annex III documents for all devices
- Clinical Evaluation — Ongoing, continuous process per Annex XIV
- Post-Market Surveillance — Proactive system per Article 83; PSUR / PMS reports mandatory
- UDI — Unique Device Identification registration in EUDAMED per Article 27
- EUDAMED registration — Manufacturers, ARs, devices, certificates, vigilance reports
- PRRC — Person Responsible for Regulatory Compliance per Article 15
- Labelling — Minimum requirements per Annex I, Chapter III
MDR vs. FDA — a quick orientation
| EU MDR | FDA (21 CFR) | |
|---|---|---|
| Approval model | CE marking via conformity assessment | 510(k), De Novo, PMA, or exempt |
| Regulatory body | European Commission + Notified Bodies | FDA CDRH |
| QMS standard | ISO 13485 (referenced) | 21 CFR Part 820 / QMSR |
| Clinical evidence | Annex XIV CER — continuous | Clinical data for submissions — event-based |
| Software | MDSW under MDR + MDCG guidance | SaMD under FDA guidance documents |
Frequently asked questions
Does MDR apply if I only sell outside the EU?
If you sell to EU countries or make your device available in the EU market — including via distributors or online — MDR applies regardless of where you are headquartered.
Is CE marking under MDD still valid?
MDD-issued certificates had transitional validity depending on class. Class IIb and III devices needed MDR certificates by May 2024 (with extensions under Regulation (EU) 2023/607). Check the specific deadline for your device class.
Do I need a Notified Body for a Class I device?
Standard Class I devices are self-certified. Class I devices that are sterile, have a measuring function, or are reusable surgical instruments require Notified Body involvement for specific aspects.
What is a PRRC?
The Person Responsible for Regulatory Compliance (Article 15 MDR) is a named individual with documented qualifications who ensures MDR obligations are met. Required for all manufacturers; can be internal or external.