For manufacturers based outside the European Union: we review your technical documentation, bring it into line with the MDR requirements and act as your Authorised Representative for placing your devices on the European market.
mdrep.eu is the EU Authorised Representative built on the regulatory team of Sistemir, which has been managing CE marking processes since 2011 for medical devices of all classes, both active and non-active: electro-medical devices, software, implantable devices, surgical instruments and medical gas systems.
As your Authorised Representative, we provide the same technical expertise: before taking on the mandate, we analyse your documentation and advise you on what needs to be added, so that placing on the market rests on a compliant basis.
Onboarding prepares the documentation and the mandate; from then on, mdrep.eu takes on and maintains the role of Authorised Representative, year after year.
Tell us about your device and your situation: we'll get back to you to define the onboarding steps.
Medical device manufacturers based outside the European Union must appoint an Authorised Representative established within the Union in order to place their devices on the European market, as provided for in Article 11 of Regulation (EU) 2017/745.
The Authorised Representative verifies that the EU declaration of conformity and the technical documentation have been drawn up, keeps a copy available to the competent authorities and cooperates with them, including in any corrective actions. mdrep.eu also retains the documents for the entire duration of the mandate.
Before taking on the mandate, we analyse your technical documentation and advise you on the changes required to correctly include mdrep.eu as your Authorised Representative. This ensures that placing on the market rests on a compliant basis from the outset.
Onboarding involves a one-off fee of €6,000. The annual fee for the Authorised Representative mandate ranges from €5,000 to €8,000, depending on the product.
Our team has been managing CE marking processes since 2011 (as Sistemir) for medical devices of all classes, both active and non-active: electro-medical devices, software, implantable devices, surgical instruments and medical gas systems.
Fill in the contact form, telling us about the device and the status of the technical documentation: we will get back to you to define the onboarding steps together.