AOJ Medical Is Now EU MDR CE Certified
AOJ Medical has completed EU MDR CE certification, allowing brand partners to place cleared home vital-sign devices on the European market.
AOJ Medical has completed EU Medical Device Regulation (MDR) CE certification. The transition from the previous directive to MDR raised the requirements for clinical evidence, post-market surveillance and technical documentation — the certification covers our home vital-sign device lines.
What this unlocks for brand partners
- Placement of cleared devices on the EU market under your own brand.
- Access to the technical file and declarations a distributor or notified body will ask for.
- A single manufacturing source covering FDA, NMPA and EU MDR requirements.
Beyond CE
Our quality and regulatory scope also includes ISO 13485, FDA clearance, NMPA registration, BSCI social compliance, RoHS, REACH, CFS and FCC — which is what lets one production line serve several regulatory regions without separate supply chains.
