European Authorized Representative for Medical Devices
According to the EU MDR 2017/745 and EU IVDR 2017/746, European Authorized Representative / EC Rep is mandatory for Non-European manufacturers wishing to sell medical devices and (IVDs) on the European market. EU Representative 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 EU.
Free Sale Certificate
We organize European Free Sale Certificate which is commonly asked by Asian and Middle East country device registrations.
EC Rep Roles and Responsibilities 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 EU 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 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 European Authorized 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 EC Rep 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.
European Authorized Representative Annual Fees
In Vitro Diagnostic Device EAR annual fees as per IVDD
|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|
Important Information's for Non-European Manufactures and Exporters
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 European Authorized Representative must keep a duplicate of the same (EC Rep). We also offer Technical Documentation Support and/or Technical File Review./p>
How to display information about EC Representative?
All Non European manufactures / Exporters must display 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?
Yes, it is required at the port of entry. The European Representative has the authority to register non-EU manufacturers and medical devices with EU authorities. Will complete the EU Registration in the nation where the EC Representative / EU Representative is based. Only after the mutual signature of a European Authorized Service Agreement and submission of signed Declarations of Conformity (DOC) and Device Test Reports can EU Registration be filed for. The average time to register for the EU is two weeks.
EC Rep & Foreign Manufacturer Agreement.
On the medical device label, the E.A.R is represented by a logo, as illustrated below. Along with the logo, the E.A.R's name and address should be stated. They are also represented on the EU Declaration of Conformity (DoC) and the IFU, respectively. In order to designate an E.A.R., the manufacturer and the E.A.R. sign a contract that essentially states: The rights and duties of each party, as well as the general method of collaboration, are discussed in addition to the agreement.
EU Registration process for Class Is / Ir / Im, IIa, IIb & III Devices
EU Registration process for Class I Medical Devices
Know the countries in European Economic Region. (EU / EEA)
Is your EU Representative business registered with EUDAMED?
Yes, we are EUDAMED and DIMDI registered. An SRN number has been assigned to us.
Is it true that your company issues EAR Certificates?
Yes. we do once the EAR Agreement is mutually signed.
Is it true that your company issues CE Compliance Certificates for class I devices?
Yes. we do.
Initial year fees covering technical file review and Certification is 1000 Euros.
Is it true that your company issues EU Registration Certificate?
Yes. We issue an EU Registration Certificate post completion of EU Device registration.