Non-EU & third-country access
Both MDR 2017/745 and IVDR 2017/746. This section covers requirements for non-EU manufacturers placing devices on the EU market, EU REP obligations, and how EU MDR/IVDR relates to non-EU regulatory systems.
This site provides general information only and does not constitute legal or regulatory advice. International regulatory requirements change frequently — always verify current requirements with the relevant regulatory authority.
Exporting to the EU — key requirements
For a manufacturer outside the EU to place a device on the EU market, they must:
1. Comply fully with MDR or IVDR
There is no simplified pathway for non-EU manufacturers. The same classification, conformity assessment, technical documentation, GSPR compliance, clinical/performance evaluation, and post-market obligations apply regardless of where the manufacturer is based.
2. Appoint an EU Authorised Representative (EU REP)
MDR Art. 11 / IVDR Art. 11 require any manufacturer established outside the EU to designate a single EU authorised representative before placing any device on the EU market. The EU REP:
- Must be established in the EU
- Is jointly and severally liable with the manufacturer for defective devices
- Registers as an economic operator in EUDAMED (obtains an SRN)
- Acts as the point of contact for NCAs within the EU
- Must be identified on the device label
The EU REP is not just a mailing address — they must have the authority and capability to carry out their regulatory obligations.
3. Register in EUDAMED
Both the non-EU manufacturer and the EU REP must register in EUDAMED. The manufacturer is registered as a foreign entity; the EU REP as an EU-based entity linked to the manufacturer.
4. Maintain technical documentation accessible in the EU
The EU REP must be able to make the technical documentation available to NCAs on request. Practically, this means the technical file must be accessible within the EU — either held by the EU REP or accessible through a secure document management system.
EU REP obligations in detail
The EU REP's obligations under MDR Art. 11 include:
| Obligation | Detail |
|---|---|
| Register in EUDAMED | Obtain SRN; maintain current registration |
| Label identification | EU REP name and address must appear on device label |
| Technical documentation access | Maintain access to or copies of relevant technical documentation |
| Cooperate with NCAs | Respond to NCA requests; facilitate inspections and investigations |
| Vigilance cooperation | Ensure vigilance reports reach relevant NCAs; coordinate with manufacturer on serious incidents and FSCAs |
| Joint liability | Jointly and severally liable with the manufacturer for defective devices placed on the EU market |
| Notify manufacturer of safety concerns | Immediately inform manufacturer of any NCA communication related to safety or non-compliance |
The EU REP relationship must be documented in a written mandate between the manufacturer and the EU REP, defining the scope of activities and responsibilities.
Switzerland, UK & MRA equivalence
United Kingdom (post-Brexit)
Since 1 January 2021, the UK has its own regulatory system for medical devices, governed by the UK Medical Devices Regulations 2002 (as amended). CE marking is no longer sufficient for the UK market (with some transitional exceptions). UK devices require:
- UKCA marking (UK Conformity Assessed) from 1 July 2024 onwards
- Registration with the MHRA (Medicines and Healthcare products Regulatory Agency)
- A UK Responsible Person (equivalent of EU REP) for non-UK manufacturers
There is no current Mutual Recognition Agreement (MRA) between the EU and UK for medical devices. Manufacturers need separate conformity assessment for EU (CE) and UK (UKCA) markets.
Switzerland
Switzerland has its own Medical Device Ordinance (MedDO) which is aligned with MDR and IVDR. Historically, Switzerland and the EU had an MRA covering medical devices, allowing mutual recognition of conformity assessments. However, this MRA was not updated after MDR/IVDR replaced MDD/AIMDD/IVDD, and its application has been complicated by broader EU-Switzerland political tensions.
Current status: Manufacturers should verify the current status of the EU-Switzerland MRA for medical devices before assuming market access. As of early 2026, divergence between Swiss and EU requirements continues to create practical challenges.
Australia
No MRA for medical devices between the EU and Australia. Devices must separately comply with Australian TGA requirements (Therapeutic Goods Act 1989, Medical Devices Regulations 2002) for the Australian market. CE marking may be used as supporting evidence in TGA submissions but does not substitute for TGA evaluation.
MDR vs. FDA 510(k) — key differences
For manufacturers familiar with FDA, the EU MDR pathway differs significantly:
| Feature | EU MDR | FDA 510(k) / PMA |
|---|---|---|
| Route type | Conformity assessment (manufacturer declares + NB reviews) | Premarket notification or approval (FDA reviews) |
| Equivalence concept | "Equivalent device" under MDR Art. 61 — strict three-criteria test; requires access to predicate's tech doc | 510(k) substantial equivalence — based on publicly available information; no tech doc access required |
| Clinical evidence | Clinical evaluation required for all classes; investigation likely for novel Class III | 510(k): mostly bench/preclinical data; PMA: clinical data required |
| Post-market | PSUR, PMCF, EUDAMED, vigilance to multiple NCAs | MDR/sMDR, MAUDE reports, 522 post-market studies |
| CE mark | Manufacturer-affixed after conformity assessment | FDA clearance/approval — federal agency grant |
| Timeline (high-risk) | 18–36+ months | PMA: 12–24+ months; 510(k): 3–12 months |
Using FDA clinical data in an EU clinical evaluation is generally acceptable (see Using international clinical data), but FDA 510(k) clearance itself does not satisfy MDR conformity assessment requirements.
Related pages
- Regulatory framework overview
- Who needs to comply — EU REPs
- Using international clinical data
- Transitional provisions & timelines
Official references
| Reference | Description |
|---|---|
| MDR Art. 11 | EU REP obligations |
| IVDR Art. 11 | IVDR EU REP equivalent |
| MDR Art. 30 | EU REP registration in EUDAMED |
| UK MDR 2002 (as amended) | UK post-Brexit medical device requirements |
| MHRA guidance | ukca.campaign.gov.uk |
| Swiss MedDO | Swiss medical device ordinance |