European Authorized Representative
According to the EU MDR 2017/745 and EU IVDR 2017/746, European Authorized Representative is mandatory for Non-European manufacturers wishing to sell medical devices and (IVDs) on the European market. The European Authorized Representative, (EC Rep) is a natural or one that is legalized and established within the EU, who has received and accepted a written mandate or decree from the manufacturer located outside of the European Union.
EU Representative
Best, Fast & Economic EU authorized representative service for Non EU Medical Device manufactures and exporters.
EU Registration
EU Registration is mandatory for EU Port of entry Permission. MDR /IVDR manufacturers must complete EUDAMED Registration.
Free Sale Certificate
We organize European free sale certificate which is commonly asked by Asian and Middle East countries device registrations.
European Authorized Representative Roles and Responsibilities of
as per Article II of EU MDR and IVDR:
- Provide a registered address in the EU to be mentioned on the product packaging;
- Keep the updated EU DOC, the Technical Documentation, and certificates permanently available at the registered address for inspection by the competent authorities;
- Maintain constant availability to represent the manufacturer in front of the European Commission, EU authorities, EU NB’s and the EU users;
- Complete applications on behalf of the manufacturer for Device registration and EU Free Sale Certificates etc.;
- Take care of any incidents reported (vigilance reporting) by the healthcare professionals, patients, and users and immediately inform the manufacturer;
- Safeguard the compliance with regulatory news and updates;
- Check the registration of the importer, of the manufacturer, of the products, and of themselves with the EU. It needs to be checked that those are updated;
- Consult and continuously support the manufacturer;
- Terminate the mandate if the manufacturer acts contrary to its obligations laid out in the EU MDR/IVDR
Formalities for changing an European Authorized Representative
As per Article 12 of the EU MDR and the EU IVDR, the detailed arrangements for a change of E.A.R should be clearly defined in an agreement between the manufacturer, where practicable, the outgoing authorized representative, and the incoming European authorized representative. The agreement should address at least the following aspects:
- The dates of termination of the mandate of the departing E.A.R and date of the beginning of the mandate of the incoming E.A.R;
- The dates until which the departing EU Representative may be specified in the information supplied by the manufacturer, including any promotional materials;
- The hand-over of documents, including confidentiality aspects and property rights;
- The responsibilities of the departing European authorized representative after the end of the mandate to forward to the manufacturer or incoming EC Rep regarding any complaints or reports from healthcare professionals and users about suspected incidents or adverse events related to a medical device/IVD for which it had been designated as the EC Rep.
EU Representative Fees
In Vitro Diagnostic Device EAR annual fees as per IVDD
| General | : | 850 Euros |
| Self-Test | : | 950 Euros |
| Annex II List B | : | 1150 Euros |
| Annex II List A | : | 1250 Euros |
| EU Registration | : | 500 Euros per device |
Medical Device EAR Annual Fees as per MDR
| Class I | : | 850 Euros |
| Class I | : | 950 Euros ( Sterile / Measuring / Reusable) |
| Class IIa | : | 1050 Euros |
| Class IIb | : | 1150 Euros |
| Class III | : | 1350 Euros |
| EU Registration | : | 500 Euros per device |
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In Vitro Diagnostic Device EAR annual fees as per IVDR
| Class A | : | 950 Euros |
| Class B | : | 1150 Euros |
| Class C | : | 1350 Euros |
| Class D | : | 1450 Euros |
| EU Registration | : | 500 Euros per device |
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The Best, Fastest, and Most Cost-Effective Medical Device EU Representative in Europe for EU Registration and Free Sale Certification
Updated Technical File / Documentation with Manufacturer and EAR
The manufacturer is responsible for maintaining the most recent revision of the technical file. The manufacturer and EU Representative must keep a duplicate of the same. We also offer technical documentation support and file review.
How to display information about EU Representative?
All Non European manufactures / Exporters must display EU authorized representative Name and contact Information with appropriate Logo along with manufacturer logo and information.
EU Registration of the Manufacturer Facility & Device. Is it mandatory?
EC Rep & Foreign Manufacturer Agreement.
EU Registration process for Class Is / Ir / Im, IIa, IIb & III Medical Devices
EU Registration process for Class I Medical Devices
Know the countries in European Economic Region. (EU / EEA)
