European Authorised Representative
for Medical Device Companies
European Authorised Representative
for Medical Device Companies
Responsible person in the EU
Responsibility of the European Authorized Representative
for Medical Devices
Responsibility of the European Authorized Representative
for Medical Devices
The obligations of the European Authorized Representative for Medical Devices are set out in in Regulation (EU) 2017/745.
In addition to the registration requirements, the European Authorized Representative must:
- verify that the EU declaration of conformity and the technical documentation have been drawn up;
- verify that an appropriate conformity assessment procedure has been carried out by the manufacturer; (if applicable)
- keep copies of all documents available and make them accessible to authorities on request; (this includes technical documentation, declarations of conformity and certificates; (including their amendments and additions)
- verify that the manufacturer has registered the required information in EUDAMED;
- cooperate with the authorities on preventive and corrective actions and immediately inform the manufacturer of complaints and requests for device samples from the authorities;
- be responsible for defective devices together with the manufacturer, if the manufacturer has not complied with the obligations of the Regulation and is not located in the EU.
European Specialized Representative for Medical Devices
European Specialized Representative for Medical Devices
Why use a specialist European Authorized Representative instead of a distributor?
Using a distributor may seem like the easiest option, but it may not be the right choice.
thanks to a specialized company that acts as a manager, you can maintain control over how your products are marketed in the European Union.
The services of Mdq as European Authorized Representative are
Custom made
Custom made
The role of AR needs an
annual fee for the responsabilities of the role. The fee is set up on the company dimension.
Every activity is then explained in an accurate price quotation.
Performance
Performance
Post market analysis and reporting. The importance of monitoring perfomance is recognised, we know where to find the information.
Compliance
Compliance
One of our qualified Engineer will take care of the conformity of your products. Devices conformity will adequately check in accordance with the MDR requirements.
Small package
Small package
Designed specifically for micro entrprises*: it contains the annual fee and the basic activities designed for small business
Medium package
Medium package
Designed specifically for small companies*: it contains the annual fee and the basic activities designed for medium business
Large package
Large package
Designed specifically for large companies*: it contains the annual fee and the basic activities designed for big companies
*in accordance with Commission Recommendation 2003/361/EC.
Our European Partner is:
Alco-Service can act as European Representative, Importer or Distributor of your products.
Alco-Service® - Via G. Borgazzi 105 - 20900 Monza (MB) - VAT N. 05921470968 - CCIAA MB1857408
Looking for a European Representative?
Contact us, we are here to help you!
Looking for a European Representative?
Contact us, we are here to help you!
We want to know your needs exactly so that we can provide the perfect solution. Let us know what you want and we’ll do our best to help.