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Non-European Manufactures and Exports can contact us for the EU Registration of your Medical Device. Hassle-free Import of medical devices into EU territory.
EU Representative for Medical Device
The EU Representative is mandatory for Non-European manufacturers wishing to sell the medical device and In-vitro Diagnostic devices (IVDs) on the European market.
EU authorized representative is known by multiple names such as E.A.R, EC Rep, European Authorized Representative, Authorized Representative, EC, or CE Representative. However, they all mean the same.
By definition according to the EU MDR 2017/745 and EU IVDR 2017/746, an Authorized Representative 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.
To act on behalf of the manufacturer in relation to specified tasks with regard to the latter’s obligations under the EU MDR/IVDR.
The EU Authorized Representative plays a crucial role in ensuring the compliance of the medical devices/IVDs manufactured by those manufacturers who are not established in the EU, and in serving as their contact person established in the EU.
EU Representative Roles & Responsibilities
Given below are some of the roles and responsibilities of the EU Representative as per Article 11 of EU MDR and EU 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
EU Representative and Foreign Manufacturer Agreement
- Manufacturer – You’ll be my E.A.R in the EU.
- E.A.R – I accept to be your E.A.R.
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.
Change of the EU Representative Authorized Services
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.
That 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 E.A.R 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 E.A.R after the end of the mandate to forward to the manufacturer or incoming E.A.R 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 representative.
EU Representative Logo
Annual EU Representative Fees
We are Regulatory Consultants and EU Representatives for Medical Devices and IVDs. Therefore, we understand your device better than any other professionals serving as EU/EC/EAR representatives.
Our services are economic and faster. Drafting and signing will not take more than 10 days.
- MDD Class I : 650 Euros
- MDD Class Is/Im : 750 Euros
- MDD Class IIa : 850 Euros
- MDD Class IIb : 950 Euros
- MDD Class III : 1050 Euros
- General IVD : 850 Euros
- Self Testing IVD : 1050 Euros
- List B IVD : 1150 Euros
- List A IVD: 1250 Euros