Classification
Classify under MDR Annex VIII or IVDR Annex VIII - EU classes differ from NMPA classes.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
Chinese manufacturers are one of the largest groups of non-EU medical device and IVD makers selling in the EU. NMPA registration does not carry over: EU market access needs CE marking under MDR/IVDR and an EU Authorised Representative.
Classify under MDR Annex VIII or IVDR Annex VIII - EU classes differ from NMPA classes.
Self-declaration for most Class I and Class A devices; a Notified Body for higher classes.
A sole EU AR with a written mandate, reviewed before appointment.
AR details on the label and instructions in the languages required by each Member State.
No. Devices placed on the EU market need CE marking under the MDR or IVDR, regardless of approvals in China.
Only if it accepts a written mandate covering the Article 11 tasks. Being a distributor alone does not make it your Authorised Representative.
Yes. Micro and small manufacturers do not need a PRRC within their own organisation but must have one permanently and continuously at their disposal (Article 15(2)). The Authorised Representative's own PRRC (Article 15(6)) does not count: under MDCG 2019-7 the two cannot belong to the same external organisation.
What the AR agreement covers.
Label requirements for non-EU manufacturers.
Economic operator registration.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Specific obligations depend on your device and company structure. Last reviewed 30 September 2026.
Tell us your device type, class and where your company is established. Before you sign a mandate, we tell you what the next step is.