I am a Chinese manufacturer. What do I need to sell in the EU?
EU MDR 2017/745 · Article 11 AR · CE Marking · EUDAMED · Non-EU Manufacturers
NMPA approval does not transfer. CE marking under the EU Medical Device Regulation is a separate legal system — and before your first unit clears EU customs, the regulation requires named, registered, and liable actors inside the Union. This page walks through exactly what EU MDR demands of a manufacturer established in China, in the order you will need it.
The short answer
Seven things stand between your factory and the EU market
Every item below is a legal requirement under EU MDR 2017/745 or an adjacent EU regulation — not a recommendation. Miss one and your devices can be detained at customs, refused by your notified body, or pulled from the market by a competent authority.
- MDR classification & CE marking — Annex VIII classification, conformity assessment, Declaration of Conformity.
- Authorised Representative in the EU — Article 11 written mandate, named on your label, before any device is placed on the market.
- Quality management system — ISO 13485:2016 aligned, covering the MDR Article 10 obligations.
- PRRC — a qualified Person Responsible for Regulatory Compliance under Article 15; your AR needs one permanently available too.
- EUDAMED registration — actor registration (SRN), UDI and device data, digital PSUR submissions.
- A compliant import chain — an identified EU importer under Article 13, named on the device or its accompanying documents.
- A running post-market system — PMS plan, PSUR/PMSR cadence, vigilance reporting clocks. CE marking is where obligations start, not end.
The path, in order
EU market entry for a China-based manufacturer, step by step
Step 1 — Classification & conformity route
Classify under MDR Annex VIII — your NMPA class does not carry over
The EU classifies devices by its own rules (Annex VIII, 22 rules), and the class drives everything downstream: Class I is self-declared; sterile, measuring or reusable surgical Class I devices and everything from Class IIa upward require a notified body. Chinese Class II devices frequently land in EU Class IIa or IIb — a different evidence burden and a 12–24 month notified body queue you should plan for early. Classification is a legal determination, and getting it wrong invalidates the entire route that follows.
Step 2 — Authorised Representative
Appoint an EU Authorised Representative (Article 11) — mandatory, not optional
A manufacturer without a registered place of business in the EU may only place devices on the market through an Authorised Representative appointed by written mandate. The AR verifies your Declaration of Conformity and technical documentation, keeps them at the disposal of competent authorities, is your legal interface with regulators — and is jointly and severally liable with you for defective devices. That liability is why serious ARs carry professional indemnity insurance and review what they sign, and why a letterbox AR is a risk to you, not a saving: if your AR is non-compliant, your market access is.
Step 3 — QMS & technical documentation
Build the technical file and QMS the EU way — Annex II/III and ISO 13485
MDR Article 10 requires a quality management system and technical documentation per Annexes II and III: GSPR mapping, clinical evaluation under Annex XIV, an ISO 14971 risk management file, labelling and IFU in the languages of every member state where you sell. Existing GB-standard test reports and NMPA dossiers can feed the file, but the structure, the clinical evidence expectations, and the state-of-the-art analysis are EU-specific. This is where most Chinese technical files fail their first notified body review.
Step 4 — PRRC
Designate a PRRC (Article 15) — and check your AR has one too
Every manufacturer must have a Person Responsible for Regulatory Compliance with defined EU qualifications — responsible for release of devices, technical documentation, PMS and vigilance obligations. Micro and small enterprises may contract the role externally rather than hire, which is how most non-EU SMEs satisfy it. Note the detail many miss: under Article 15(6), your Authorised Representative must also have its own PRRC permanently and continuously at its disposal.
Step 5 — EUDAMED
Register in EUDAMED — SRN, UDI, and digital PSUR submissions
Your AR triggers actor registration with its competent authority, producing the Single Registration Number (SRN) your notified body requires before certification. Device and UDI-DI data follow. Since 28 May 2026, periodic safety update reports are submitted digitally through EUDAMED on statutory deadlines — a live operational obligation with an audit trail, not a one-time form.
Step 6 — Import chain
Line up your importer and distributors (Articles 13–14, 16)
The first EU entity that places your device on the market is an importer with its own verification duties — and its name goes on the device or its packaging or accompanying documents. Distributors carry Article 14 checks. And be careful with private-label arrangements: under Article 16, a distributor or importer that rebrands your device under its own name legally becomes the manufacturer, with everything that entails. If you sell direct to EU consumers online, Article 6 puts you under the same obligations as physical-channel sales.
Step 7 — Post-market obligations
Run the post-market system — the part that never stops
CE marking starts the clock on continuous obligations: a PMS system aligned to MDCG 2025-10, PSURs or PMSRs on statutory cadence, complaint trending, and vigilance reporting with 24-hour, 72-hour and 30-day clocks that run on EU time — literally. For a team in Shenzhen or Suzhou, a serious incident reported on a Friday evening EU time is a Saturday morning problem in China. Someone inside the EU needs to be on standby for those clocks.
Where it goes wrong
The five mistakes we see most from China-based manufacturers
Treating the AR as a letterbox
A €1,000/year AR that never reads your technical file is a liability, not a bargain. Competent authorities audit ARs, and an AR that terminates its mandate — or is found non-compliant — halts your market access overnight.
Assuming NMPA evidence transfers
EU clinical evaluation under MEDDEV 2.7/1 rev.4 and Annex XIV has its own equivalence rules and state-of-the-art expectations. Chinese clinical data can contribute, but a technical file built by translating an NMPA dossier fails review.
Labelling and language gaps
Missing AR name and address on the label, missing importer identification, or IFU only in English and Chinese. Member states set their own language requirements — the IFU must follow the market, not the factory.
Ignoring the parallel regulations
A device with a companion app processing EU users' health data needs a GDPR Article 27 Representative. Consumer accessories outside MDR scope fall under GPSR, which has its own Responsible Person requirement. Three representative mandates, usually discovered one customs detention at a time.
Stopping at the certificate
PMS, PSUR deadlines, EUDAMED submissions and vigilance standby are running obligations. Notified bodies now audit against MDCG 2025-10 — a dormant PMS system is a finding waiting to be written.
How QLE covers it
One partner, all three mandates — under one insured agreement
The EU Market Access Bundle is built for exactly this situation: a non-EU manufacturer that needs its EU legal infrastructure in place before revenue moves, without negotiating three separate contracts with three separate firms.
| Included in the bundle | What it satisfies |
|---|---|
| MDR Authorised Representative | EU MDR Article 11 — written mandate, technical documentation verification, competent authority interface, name on your label. |
| GPSR Responsible Person | Regulation (EU) 2023/988 — for accessories and consumer products outside MDR scope. |
| GDPR Article 27 Representative | EU representation for processing of EU personal data — companion apps, connected devices, EU clinical data. |
| EUDAMED actor registration | SRN issuance handled end to end, ready for your notified body. |
| Free Sale Certificates | MDR Article 60 — as your Belgian AR, QLE requests Certificates of Free Sale from the FAMHP for your CE-marked devices, the document most third markets (Middle East, Latin America, Southeast Asia) require to register your device there. |
| PRRC (optional bolt-on) | MDR Article 15 — named, qualified, insured PRRC at standard retainer tiers from €1,800/month. |
€5,500–9,000 / year depending on portfolio size (1 file / up to 3 / up to 6), plus a €750 one-time setup. All named-representative mandates are covered by €1M professional indemnity insurance, in force before signature — because an AR that carries joint liability without insurance is a red flag your notified body will notice too.
Working with teams in China. QLE is remote-first and Brussels-based — seven hours behind CST in summer. Your afternoon is our morning: scoping calls, document reviews and notified body correspondence run comfortably within your working day, and EU vigilance clocks are covered from inside the EU while your team sleeps.
Quick answers
Frequently asked, directly answered
Does my NMPA registration or GB testing count in the EU?
No — there is no mutual recognition. Your device must be classified and CE-marked under EU MDR from the ground up. Existing test reports can sometimes support the technical file; they never replace it.
Can I ship to a distributor first and sort out compliance later?
No. The AR mandate, CE marking, and registrations must exist before a device is placed on the market. Importers are legally required to verify all of it — a compliant EU importer will refuse your shipment, and a non-compliant one exposes you both.
How long does EU market entry take?
The representative and registration layer (AR, SRN, GDPR/GPSR mandates) can stand in weeks. The critical path is the technical file and — for Class Is/Im/Ir, IIa and above — the notified body: budget 12–24 months depending on class, evidence maturity, and NB capacity. Class I self-declared devices move much faster.
Can I get a Free Sale Certificate to register my device outside the EU?
Yes — and this is one of the practical benefits of an EU footprint. Under MDR Article 60, Certificates of Free Sale are issued by the competent authority of the member state where your Authorised Representative is established. As your Belgian AR, QLE requests them from the FAMHP for your CE-marked devices — the document regulators in the Middle East, Latin America and Southeast Asia typically require before registering an EU-certified device.
My importer offered to act as my Authorised Representative. Good idea?
Usually not. It concentrates your market access in a party with its own commercial interests — and if you change importer, you lose your AR, your label text, and your EUDAMED chain at the same time. An independent AR keeps your regulatory infrastructure stable while commercial relationships change. Also remember Article 16: an importer rebranding your device becomes the manufacturer.
Next step
Know your route in 30 minutes
Bring your device description and intended EU markets. You leave the call with your likely MDR class, the conformity route, which mandates you need, and a written fee — whether or not you engage us. Calls scheduled to suit China working hours.
QLE Group BV · Brussels, Belgium · MDR Authorised Representative, GPSR Responsible Person and GDPR Article 27 mandates under one PI-insured agreement.