Manufacturers of medical devices and diagnostic tests located outside the European Union that intend or have a market authorisation in the European Single Market (European Union, EEA, Switzerland, and Northern Ireland) will need to appoint an Authorised Representative located in the European Union (EU). The roles and responsibilities of an Authorised Representative are described in the EU Medical Devices Regulation 2017/745 (“MDR”) and EU in vitro Medical Devices Regulation 2017/746 (“IVDR”):
Authorised representative means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation.
The starting date of these new EU Regulations is 26 May 2022 and manufacturers of new IVDs and MDs that are based outside the EU will need to appoint an EU-based Authorised Representative. Preventing a major market disruption, the EU authorities allows for a transition period for existing devices until 26 May 2025. From then onward, all marketed medical devices and in vitro diagnostics will need to comply with the new Regulations and have appointed an Authorised Representative, or their device(s) will need to be withdrawn from the market.
HALO Research Technology BV or HALO is established in The Netherlands with an affiliated branch office in the United Kingdom. HALO provides regulatory and business consultancy services for medical devices companies that need support in developing their products in compliance with the EU Regulations (IVDR and MDR) and those companies outside the EU. HALO can serve as well as Authorised Representative in the EU for their products. HALO collaborates closely with the EU Reference Center of Medical Devices at the Technical University of Graz, the network of European Biobanks, and the medical faculties of several EU Universities and has privileged access to a conformity assessment laboratory, competent authority, and notified body.
HALO is the trusted business partner for manufacturers that would like to have market access in the European Single market. HALO verifies if a device has the required EU declaration of conformity and certificates, including amendments, supplements, and associated technical documentation. HALO verifies if the appropriate conformity assessment procedures have been carried out, and if the device is registered in the EU digital database (EUDAMED). HALO keeps records of technical documentation of the devise(s) and will serve as the focal contact for EU-based competent authorities, notified bodies and conformity assessment bodies. Upon the requests of these authorities HALO will provide them with technical documentation and/or samples. HALO will be the preferred communication channel for any requests, notifications and/or orders, cooperating on behalf of the manufacturer on any preventive and corrective actions.
HALO can provide support for the entire range of devices according to risk classification (class A, B, C, and D for in vitro devices, and class I, IIa, IIb, and III for regular medical devices). HALO’s fee structure will be determined by the risk classification of the device.
If you are interested in these services, please contact:
Donald de Korte (donald@halo-research.com) or Alan Boyce (alan@halo-research.com)
