EU Authorised Representative Services MDR-IVDR
We help you comply with the European medical device regulation.
Medical Device and In-vitro products
Why do you need a European Authorized Representative?
Non-EU based manufacturers of Medical Devices and In Vitro Diagnostic products are legally obligated to appoint an Authorised Representative to commercialise their products within the EU Market.
Your European Authorized Representative serves as a liaison between you and the national Competent Authorities (Ministries of Health) inside the European Union.
Excerpt from Regulation (EU) 2017/745 on medical devices
Article 11
Authorised representative
1.Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
2.The designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.
3.The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative 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:
(a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
(b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
(c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;
(d) 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;
(e)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 and verify that the competent authority receives the samples or is given access to the device;
(f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
(g) 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;
What Will we do for you?
1) Allow you to use European Pharma Partner’s name and details on your product labelling as your official European representative.
2) Verify that the EU declaration of conformity and technical documentation have been drawn up.
3) Comply with the registration obligations in European Official Database (EUDAMED).
4) Communicate on your behalf with the EU national competent authorities.
5) Inform you about complaints from healthcare professionals and patients.
6) Cooperate with the competent authorities on any preventive or corrective action taken.
Check out some useful links – Basic information related to MDR and IVDR
Medical Devices Regulation (2017/745/EU) (MDR) – Complete text in English of the present MDR regulation in effect since the 27th of May 2021
In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) – Complete text in English of the IVDR regulation that will come into effect on the 27th of May 2022
The ‘Blue Guide’ on the implementation of EU products rules 2016 (Text with EEA relevance)
European Medical Device Nomenclature (EMDN) – Utilised by manufacturers for the registration of medical devices in EUDAMED, where it will be associated to each Unique Device Identifier – Device Identifier (UDI-DI)
European database on medical devices (EUDAMED) – It is composed of six modules: Actor registration, Unique device identification (UDI) and device registration, Notified bodies and certificates, Clinical investigations and performance studies, Vigilance and market surveillance.
List of Notified Bodies MDR – Updated list of aproved Notified Bodies to comply with the Medical Device Regulation
List of Notified Bodies IVDR – Updated list of aproved Notified Bodies to comply with the In Vitro Diagnostic Medical Devices Regulation
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