According to MDR (EU) 2017/745 and IVDR (EU) 2017/746, the authorized representative in the EU is a legal or natural person established in the EU, 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 MDR/IVDR. All non-EU manufacturers have the obligation to appoint at least one authorized representative (there can be no more than one authorized representative for the same product family). The authorized representative must be registered in the EUDAMED database before the manufacturer can start his registration.
The authorized representative is materially responsible for the compliance of the medical device before the authorities and consumers in the EU, jointly and equally with the manufacturer.
Salus Cons Kft. is registered as an authorized representative in the EU under the single registration number HU-AR-000006177.
As authorized representatives, we have an obligation to check the accuracy of the technical documentation before accepting the mandate. For clients for whom we prepare technical documentation, this check is an integral part of our service and is not charged separately.
After checking the documentation, we start signing the representation agreement, after that the client can access the registration in the EUDAMED database.
If the signing of the contract is part of the process of verification of technical documentation by the notified body, a clause is included in the contract according to which market representation begins to run from the date of issuance of the EC certificate.
Depending on the requirements and needs of the client, Salus Cons Kft. also participates in post-marketing monitoring of products.
We also offer the service of an authorized representative for the needs of clinical trials, in accordance with Annex XV of the Medical Regulations.