European Authorized Representative!
The European Authorized Representative (EC Rep) is one that is legalized and established within the EU and who has received and accepted a written mandate or decree from the manufacturer located outside of the European Union. According to EU MDR 2017/745 and IVDR 2017/746, an EC representative is mandatory for non-European manufacturers wishing to sell medical devices (IVDs) on the European Union market.
FREE SALE CERTIFICATE
30 Working Days
EU Authorized Representative Responsibilities
(A) Non-European manufacturers can only import and sell medical and in vitro devices on the market of the European Union after designating a single European Authorized Representative.
(B) The designation will serve as the EC Representative’s authority, and it will only be effective for all devices in the same generic device group if it is approved in writing by the EC Representative in the mutually signed EAR agreement.
(C) The EU Authorized Representative shall perform the tasks specified in the mandate agreed upon between EAR and the manufacturer. The Representative shall provide a copy of the EAR Agreement/mandate to the competent authority, upon request.
- Regarding the devices it encompasses, the mandate must stipulate that the manufacturer must permit the EC Rep to carry out at least the following duties.
- For the period specified in Article 10(8), keep a copy of the technical documentation, the EU declaration of conformity, and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at the disposal of competent authorities.
- Comply with the registration obligations outlined in Article 31 and verify that the manufacturer has followed the registration obligations outlined in Articles 27 and 29
- In response to a request from a competent authority, provide that competent authority with all the information and documentation required to show a device’s conformity in an official Union language determined by the Member State concerned.
- Forward to the manufacturer any request for samples or access to a device made by a competent authority of the Member State in which the EC Rep has its registered place of business and verify that the competent authority gets the samples or is granted access to the device.
- Collaborate with competent authorities on any preventive or corrective action taken to eliminate or, if possible, mitigate the risks presented by devices.
- Promptly notify the manufacturer of any complaints or reports received from healthcare workers, patients, or users regarding suspected incidents involving a device for which they have been designated.
- Cancel the mandate if the manufacturer violates its duties under this Regulation.
(D) The mandate alluded to in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11), and (12) shall not be delegated. (12).
(E) Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has failed to meet the obligations outlined in Article 10, the EC Representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
(F) An European Authorized Representative who terminates its mandate for the reasons specified in paragraph 3 point (h) shall immediately notify the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the device’s conformity assessment of the termination of the mandate and the reasons for it.
(H) Any reference to the competent authority of the Member State in which the manufacturer has its registered place of business in this Regulation shall be interpreted as a reference to the competent authority of the Member State in which the EU authorized representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.
The European authorized 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 EC Rep
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 European Authorized Representative, and the incoming EC Rep. 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
- EC Rep 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
EU Authorized Representative Pricing / Fees
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 EC 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 Representative 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 Rep Logo Display
All Non European manufactures / Exporters must display EC Rep Name and contact Information with appropriate Logo along with manufacturer logo and information.