European Authorized Representative for Medical Device
According to the EU MDR 2017/745 and EU IVDR 2017/746, European Authorized Representative is mandatory for Non-European manufacturers wishing to sell the medical device and (IVDs) on the European market. EC Rep is a natural or one who 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.
European Authorized Representative 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
Changing an EC Rep for Medical Device
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 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 authorized EC Representative.
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EC Representative Fees
EC Rep Quote Request for Medical Device
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Annual EAR Service MDD
Annual EAR Service IVD
Model addition Fees
Important Information's for Non-European Manufactures and Exporters
EU Registration of Manufacturer & Medical Device
European Representative is authorized to register Non European Manufacturer and Medical Device with EU Authorities. The EU Registration will be done from the country where EC Rep / EU Rep is headquartered. EU Registration can be applied only after mutual signing for European Authorized Service Agreement and submission of signed Declaration of Conformity (DOC) and Device Test Reports. General timeline for EU Registration is 2 weeks
EC Rep & Foreign Manufacturer Agreement
The E.A.R is represented on the medical device label with a logo as shown below. Along with the logo, the name and the address of the E.A.R should be mentioned. Secondly, they are represented on the EU Declaration of Conformity (DoC) and thirdly on the IFU. In order to designate an E.A.R., an agreement is signed between the manufacturer and the E.A.R. which essentially says. In addition to the agreement, the rights and obligations of each party and the general manner of cooperation are also mentioned.
Technical File / Documentation
It is the responsibility of the manufacturer to maintain the latest revision of the technical file. A copy of the same must be kept with the manufacturer and European Authorized Representative (EC Rep). We also provide Technical Documentation Support and or Review of Technical File
Display EC Representative Name and Contact Information
All Non European manufactures / Exporters must display Authorized Representative Name and Contact Information with appropriate Logo along with Manufacturer Logo and information.