Last 13th October, with much anticipated vote, the Medical Devices Committee of the European Commission voted on the draft Implementing Act code D080753/07 which lays down Common Specifications for all products indicated in Annex XVI of the MDR Regulation (EU) 2017/745 on Medical Devices.
This Annex refers to all products intended for non-medical or aesthetic purposes, similar to Medical Devices in function and risk profile, which fall under the MDR scope to ensure the health and safety of users and patients.
The Common Specifications as so far defined should regulate, as for non-clinical devices, the application of risk management and reclassification, labelling and instructions for use, Technical Documentation requirements, including performance evaluation, post-market surveillance and conformity assessment, in general and specifically for each listed product category.
Devices listed in Annex XVI include:
- Contact lenses, such as non-prescription coloured contact lenses;
- Products intended to modify the anatomy or fix parts of the body, with the exception of products for tattooing or piercing;
- Substances intended for facial or subcutaneous injection, such as dermal fillers;
- Equipment intended for liposuction, lipolysis or lipoplasty;
- Equipment emitting high-intensity electromagnetic radiation, such as lasers or intense pulsed light equipment;
- Electrical equipment for brain stimulation.
Impact of Annex XVI on Manufacturers
Manufacturers of devices listed in Annex XVI must demonstrate compliance with the Common Specifications within six months of the date of entry into force of the implementing acts, while also involving a Notified Body where appropriate.
In addition to complying with the Common Specifications, manufacturers of such devices will have to meet the MDR requirements of Art. 10:
- Ensure that the device has been correctly classified with respect to the risk classification criteria in Annex VIII and by way of derogation from the implementing act for the reclassification of certain active products with a non-medical purpose;
- Meet all relevant General Safety and Performance Requirements (GSPRs) of Annex I, including the quality-and-risk-management-systems;
- Pass the applicable conformity assessment carried out by a Notified Body;
- Draw up a declaration of conformity and affix the CE mark;
- Assign a basic UDI of the device and provide it to the UDI database;
- Submit to Eudamed key information on the manufacturer, Authorised Representative and/or importer if not located in the EU;
- Nominate a PRRC;
- Provide periodic safety update reports;
- Satisfy post-market surveillance requirements, including the reporting of serious incidents and safety corrective actions to Competent Authorities;
- Ensure that distributors and importers of such devices have fulfilled their obligations under Articles 13 and 14.
Thema can help you: thanks to our strategic-regulatory consulting services and CE certification support Thema’s experts can guide you in complying with the Medical Devices MDR (UE) 2017/745 Regulation requirements for Annex XVI-products.
Contact us for more information.