MDR / Regulatory Notices
Manufacturing standard
EasyAligners clear aligners are manufactured by a partner operating under an ISO 13485-certified quality management system, covering design, production and post-market surveillance for medical devices.
Regulatory status
Devices supplied into the UK and EU are manufactured to meet the requirements of the EU Medical Device Regulation (2017/745) and the UK Medical Devices Regulations, as applicable to the practice’s territory. Certificates and Declarations of Conformity are held by our manufacturing partner and are available to partner practices on request.
Intended purpose
The aligners are intended for the orthodontic repositioning of teeth, manufactured against a prescription and digital treatment plan approved by a registered dental professional at the submitting practice.
Vigilance and incident reporting
Practices should report any suspected device-related incident or adverse event to EasyAligners promptly so it can be assessed. This does not replace a practice’s own duties: incidents may also be reported directly to the MHRA through the Yellow Card scheme, or to the relevant national competent authority in the EU.
Documentation requests
Requests for certificates, Declarations of Conformity and technical file extracts can be sent to partnerships@easyaligners.co.