Planning to bring medical devices or in vitro diagnostic devices to the European market? If your company is based outside the EU, you generally need an EU Authorised Representative before placing your products on the market.
Relevant for manufacturers based in
Elevate Medtech provides EU Authorised Representative services through ELEVATEMEDTECHEU OÜ, providing a designated point of contact within the Union and performing the regulatory responsibilities associated with the role. Whether you are entering the EU market for the first time or looking to change your existing representative, we can discuss your requirements and the next steps.
Looking for an EU Authorised Representative? Contact Elevate Medtech to discuss your needs.
The Role
An MDR EU Authorised Representative acts on behalf of medical device manufacturers established outside the European Union. Under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), the representative has specific legal duties and serves as a contact point for European regulatory authorities.
The relationship is governed by a written mandate that defines the representative’s responsibilities. Although the representative can support regulatory compliance, the manufacturer remains responsible for its own legal obligations.
For a detailed explanation of the legal framework, responsibilities and potential liability, read our article on the EU Authorised Representative.
Manufacturers without a registered place of business in the EU generally need to appoint an EU Authorised Representative before placing medical devices or in vitro diagnostic devices on the EU market. This includes manufacturers based in countries such as:
Our Services
ELEVATEMEDTECHEU OÜ acts as the appointed EU Authorised Representative and performs the tasks required under the applicable MDR or IVDR, as defined in the agreed mandate. In the service descriptions below, “we” refers to this EU-established entity.
Documentation
We check that the required EU declaration of conformity and technical documentation exist and, where applicable, that the manufacturer has carried out the appropriate conformity assessment. We also keep the required documents available for the relevant authorities.
Registration
Authorised representatives must register their details in EUDAMED, the European database for medical devices, and verify that manufacturers have fulfilled their own applicable registration obligations. ELEVATEMEDTECHEU OÜ fulfils the responsibilities assigned to the authorised representative under the applicable regulation.
Authorities
We act as a designated point of contact for relevant regulatory matters. On request from a competent authority, we provide the information and documentation necessary to demonstrate the device’s conformity, in an official Union language determined by the Member State concerned.
Vigilance
We immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users concerning suspected incidents involving devices covered by our mandate. We also cooperate with competent authorities on preventive and corrective measures.
Anne is your contact for EU representation. She reviews your devices, your current arrangements and your timeline with you, and discusses the next steps for your EU Representative mandate.
Book a Call →Whether you are preparing to enter the European market or considering a change of representative, Elevate Medtech can discuss your requirements and the arrangements needed for your products. Get in touch with Elevate Medtech to discuss your needs, learn about EU authorised representative costs, and find out how we can help.