Most O&P, foot health and rehabilitation products are Class I or Class IIa under the EU Medical Device Regulation (EU 2017/745). We build and maintain the technical documentation that keeps your CE mark sound, and the post-market systems that notified bodies and authorities now check.
Key points for our sector
- Class I devices such as most orthoses, insoles and rehabilitation aids are self-declared by the manufacturer, but still need full technical documentation, risk management, clinical evaluation and post-market surveillance
- Class Is, Im and IIa and above need a notified body
- Custom-made devices made to a written prescription follow Annex XIII, with their own documentation and statement requirements
- Non-EU manufacturers need an EU Authorised Representative, and devices must be registered in EUDAMED
- Legacy devices under the old directives have transition periods running to the end of 2027 or 2028 depending on risk class, and the European Commission has proposed targeted simplifications to the MDR
How we help
- Classification and conformity route
- MDR technical documentation, risk management (ISO 14971), clinical evaluation, biocompatibility and usability
- Labelling, IFU and UDI
- ISO 13485 quality systems and notified body audits
- EU Authorised Representative and EUDAMED registration
- Post-market surveillance, vigilance and PSURs
- General Product Safety Regulation (GPSR) compliance for non-medical products sold in the EU
Delivered by Deliberate
EU MDR technical documentation and certification in Germany.
Talk to us about the EU
Tell us your device, its classification today and where it is already approved, and we will map the fastest compliant route.
