E.A.R. For Medical Device Manufactures

REGULATIONS (EU) 2017/745 and (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 about E.A.R

"For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in
ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the
authorised representative, legally liable for defective devices in the event that a manufacturer established outside
the Union has not complied with its general obligations. The liability of the authorised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the
authorised representative should be jointly and severally liable with the importer and the manufacturer. The tasks
of an authorised representative should be defined in a written mandate. Considering the role of authorised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualification, which should be
similar to those for a manufacturer's person responsible for regulatory compliance."

WHO CAN BE AN AUTHORIZED REPRESENTATIVE?

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.

RESPONSIBILITIES OF AN AUTHORIZED REPRESENTATIVE
  • Verify that the EU declaration of conformity and technical documentation have been drawn up;
  • Keep available a copy of the technical documentation, the EU declaration of conformity;
  • Comply with the registration obligations laid down and verify that the manufacturer has complied with the registration obligations
  • 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
  • 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
  • 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

WHY WITH US?

In 2021, our company successfully passed the registration in EUDAMED us economical operator 

  AUTHORISED REPRESENTATIVE  ( SRN: CZ-AR-000000584 ).
We will provide you with all services to fulfil of the main conditions for obtaining a CE certificate for your products - the obligatory presence of an authorized representative in the EU. All this will be done in accordance with the standards and directives of the European Union. Choosing the right EAR is important.

 Since there are several options for choosing an EAR, we have to choose the right one only together with you. This will depend on many factors: the type of product and its features, the duration of the service, the volume of obligations, etc.

 Changing an EAR in the event of a wrong choice can be very costly, as revoking the mandate of a representative office in the event of a breach of contract may result in a ban on the sale of your products throughout the EU.

 We will be able to choose the model that will minimize possible risks. Of the possible options that exist today, we offer:
  • Option I     Creation of a legal entity - an EU company in the Czech Republic, which acts as your authorized representative. It can be either your subsidiary, where your company will be the founder, or an independent company with other founders, possibly even foreign individuals.

  • Option II   Issuance of an EAR mandate for your distributor or importer in the EU. We, in turn, will prepare all the necessary documents for this.

  • Option III   Our Czech company will act as EAR We will ensure that the obligation to represent your interests as an authorized representative in the EU is formalized accordingly. In any case, we are ready to provide you with a comprehensive solution in obtaining CE certificates and, as part of it, provide an agreement with EAR However, if you need only the services of an authorized representative, we will definitely find the best solution for you.
     
Contact us! We will help you competently also draw up technical documentation, labelling, test products and conclude an agreement with an authorized representative.  

our PRICE FOR E.A.R SERVICES

FROM 2300 EUR
 per annum

I class MDR CLASS A IVDR

FROM 2700 EUR
 per annum

II a, B class MDR Class C,B IVDR

from 3500 EUR  per annum

III class MDR Class D IVDR

FORM for REQUEST

Write us if you need E.A.R. serivices
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European Regulatory Compliance Services

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