EU Medical Device Registration
The European Union (EU) requires medical device manufacturers based outside of the EU to appoint an EU Authorized Representative who has a registered premises in an EU member country to act on behalf of the medical device manufacturer, for the purposes of registering those manufacturers medical devices on EUDAMED (European database on medical devices) under the EU Medical Device Regulations and Invitro Diagnostic Regulations (MDR 2017/745 and IVDR 2017/746).
Under Article 11 of the Medical Device Regulations EU 2017/745 and In Vitro Diagnostic Device Regulations EU 2017/746 Authorised Representatives must fulfil the following legal obligations:
Must be the sole EU Authorised Representative of the Manufacturer
A mandate between the authorised representative and manufacturer covering all the devices of the same generic device group.
The authorised representative shall perform the tasks specified in the mandate and shall provide a copy of the mandate to the competent authority, upon request. The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:
- verifying that the EU declaration of conformity and technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out by the manufacturer;
- keep available a copy of the technical documentation, the EU declaration of conformity and a copy of the relevant certificate at the disposal of competent authorities.
- comply with the registration obligations within the regulations.
- in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
- forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device.
- cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices;
- immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
- terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
The name and address of the EU Authorised Representative, where applicable, must be included on the product labelling or the outer packaging, or the instructions for use in cases where the CE marking has been affixed.
With a registered office in Germany Patient Guard under its subsidiary Patient Guard Europe UG can provide full EU Authorised representative services to you as a medical device manufacturer if you do not have a registered office in an EU member state. If you are interested in this service, then please contact us for further information.
Medical Device Registration
All Medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered in the relevant countries or…