European Authorized Representative
According to the EU MDR 2017/745 and IVDR 2017/746, EC Rep is mandatory for Non-European manufacturers wishing to sell medical devices and (IVDs) on the European market. The European Authorized Representative is a 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.
4 Working Days
10 Working Days
30 Working Days
European Authorized Representative Responsibilities
- European Authorized Representative provide a registered address in the EU to be mentioned on the product packaging
- Keep the updated technical documentation available for inspection by the competent authorities
- Represent the manufacturer in front of the European Commission, NB’s and the users
- Device registration and EU Free Sale Certificates
- Take care of incidents reported by the healthcare professionals, patients, and users
- Safeguard the compliance with regulatory news and updates
- Check the registration of the importer, manufacturer with the EU and update accordingly
- EU Authorized Representative consult and continuously support the manufacturer
- Terminate the mandate if the manufacturer acts contrary to MDR/IVDR obligations
- Review and guide on PMS, PMCF and PSUR requirements, if required
The European Authorized Representative or EC Rep is responsible for ensuring that the company has a lawful presence in the European Union and that it complies with all applicable laws. The European Authorized Representative works closely with its parent company to ensure that the corporation is compliant with regulations and procedures. In addition, this individual also oversees the day-to-day activities of the corporation’s business in terms of managing employees, finances, and other responsibilities.
EAR Agreement
The EC Representative is represented on the medical device label with a logo, as seen below. Along with the logo, the EAR name, address, and contact information must be printed on the Declaration of Conformity (DOC), Technical Documentation, and in the Instructions for Use (IFU). To appoint an European Authorized Representative, the manufacturer must sign a contract outlining each party’s rights and responsibilities, as well as the general way of collaboration and costs.
Formalities for changing and existing 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 EU Authorized Representative, and the incoming European Authorized Representative. The agreement should address at least the following aspects:
- Provide a registered address in the EU to be mentioned on the product packaging
- Keep the updated technical documentation available for inspection by the competent authorities
- Represent the manufacturer in front of the European Commission, NB’s and the users
- Device registration and EU Free Sale Certificates
- Take care of incidents reported by the healthcare professionals, patients, and users
- Safeguard the compliance with regulatory news and updates
- Check the registration of the importer, manufacturer with the EU and update accordingly
- EU Authorized Representative consult and continuously support the manufacturer
- Terminate the mandate if the manufacturer acts contrary to MDR/IVDR obligations
- Review and guide on PMS, PMCF and PSUR requirements, if required
European Authorized Representative Pricing
Benefits of working with I3CGLOBAL
- ISO 27001:2013 Certified data security system. We safeguard the confidentiality of technical documents and other information you provide to us.
- When judgments must be made that go against the interests of an importer/distributor, we operate in your best interests.
- While distributors and corporate branch offices may have other priorities, we react to inquiries from authorities quickly and effectively.
- Unlike other legal firms and trading organizations, we are regulatory consultants for medical devices. We provide quality and compliance knowledge in countries outside of the EU, such as the United Kingdom and the United States, ensuring that manufacturers obtain good value for money throughout the EAR process and other significant markets.
EU Registration Process
Yes, it is required at the port of entry. The EU Authorized 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 Rep 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.
EUDAMED Registration Process
EUDAMED Registration will improve openness for the general public and healthcare professionals, as well as the coordination of information on medical devices and IVDs on the EU market.
European Free Sale Certificate and Countries That Issues
The European Free Sale Certificate (FSC) is proof that medical equipment can be lawfully sold or distributed freely and without limitation with the consent of the country’s regulatory authorities.
EC Representative Logo Display
All Non European manufactures / Exporters must display European Authorized Representative Name and contact Information with appropriate Logo along with manufacturer logo and information.
