EU Representative For Medical Devices!
According to EU MDR, 2017/745 and IVDR 2017/746, an EU Representative is mandatory for Non-European manufacturers wishing to sell medical devices and In-Vitro diagnostic devices on the EU market. We are delighted to offer the European Authorized Representative services for you!
EU REPRESENTATIVE
4 Working Days
EUDAMED REG
10 Working Days
FREE SALE CERTIFICATE
30 Working Days
Quick Contact
EU Representative - An Overview
EU Representative means any natural or legal person established within the union who has received and accepted a written mandate from a manufacturer outside the union to act on the manufacturer’s behalf about specified tasks as per new medical devices and Invitro diagnostic devices regulation.
Why EU Representative for MDR 2017/745 and IVDR 2017/746
Under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the EU Representative is assigned a narrowly defined role with the belonging obligations.
Foreign manufacturers must appoint an EU Representative before selling their medical and in vitro diagnostic devices in the European Union. The EC Rep acts as the manufacturer’s regulatory representative in the European Single Market and is the point of contact between the foreign manufacturer and the EU Competent Authorities.
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EU Representative Requirement for Non-EU Manufacturers
EU Representative plays a crucial role in helping Non-EU medical device and in-vitro diagnostic manufacturers navigate the MDR 2017/745 and IVDR 2017/746 ensuring vigilance, claim handling, incident handling, serious adverse events and reporting to competent authorities and notified bodies if asked so.
- Verifying that the manufacturer’s technical documentation file for correct as per guidelines and conformity procedure.
- Maintaining copies of the technical file. (EAR must maintain documentation for 15 years.)
- Granting authorization to include the EAR name and address on the device label and declaration of conformity
- Executing an agreement (mandate) with the manufacturer to outline the obligations of both parties throughout the product’s lifespan in the EU market.
- Apply, review and verify the manufacturer’s EUDAMED Single Registration Number (SRN)
- Ensure that the manufacturer has fulfilled EUDAMED registration obligations.
- Provide Competent Authorities with on-request technical documentation.
- Inform the manufacturer of any complaints from healthcare professionals, users, and patients from the EU territory
- Support Incident and Field Safety Corrective Action (FSCA) reporting, collaborating with the manufacturer and importers/distributors as necessary.
Responsibilities of EU Representative
(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 EU 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 Rep in the mutually signed EAR agreement.
(C) The 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 Representative 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 Representative 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 European Authorized Representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
(F) A European authorized representative who terminates its mandate for 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.
(G) 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 Representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.
We are EU Regulatory experts and European authorized representative for Medical Devices and In Vitro Diagnostic Devices. The I3CGLOBAL team can help you overcome any EU regulatory challenges. Contact us for seamless navigation, customer friendly attitude and economical pricing
Agreement and Mandate Documents
The terms “EU Representative Agreement” and “Mandate” are often used interchangeably but can have slightly different contexts. However, in the context of appointing an European authorized representative for medical device, they typically refer to the same contractual arrangement between the foreign manufacturer and the EU Rep.
EU Representative Agreement: This is a formal agreement or contract between the manufacturer and the European Representative. It outlines the responsibilities, duties, and obligations of both parties regarding regulatory compliance, communication with authorities, and other relevant aspects related to the marketing of medical devices within the European Union.
Mandate: This refers to the authorization granted by the manufacturer to the European Representative to act on its behalf within the EU market. This mandate empowers the EU Rep to fulfil certain tasks and responsibilities outlined in the agreement. It essentially delegates certain regulatory and compliance-related functions to the Representative
In summary, while the terms may differ slightly, they generally refer to the same contractual arrangement between the manufacturer and the European authorized representative, outlining their respective roles and responsibilities in ensuring compliance with EU regulations for medical devices.
U Representative Appointment Process
Essential Formalities for Changing or Switching from Current 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 EU 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 Certificate
- 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
We are EU Regulatory experts and European Authorized Representatives for Medical Devices and In Vitro Diagnostic Devices. The I3CGLOBAL team can help you overcome any EU regulatory challenges. Contact us for seamless navigation, customer friendly attitude and economical pricing
Benefits of Appointing I3CGLOBAL
Our EU Representative services offer complete support for medical device and In-vitro diagnostic manufacturers seeking to enter or maintain their presence in the European market. Below are a few reasons why you might consider our services.
- We are an ISO 27001:2013 Certified data security system. So, all customer inputs and technical documents are safeguarded for many years.
- 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 scientific, and regulatory compliance information to all our clients outside the EU ensuring that manufacturers receive accurate information and value for their investment.
Overall, by appointing our EC Rep Services, we guide appropriately and overcome all the complexities of regulations (SRN, ACTOR, UDI, EUDAMED) more efficiently and ensure full adherence with MDR 2017/745 and IVDR 2017/746 requirements for any risk class and type of device.
Frequently Asked Questions
Is the EU Representative fee annul?
Yes. The EU Representative services fee is every year. (12 months from the date of appointment)
What is product liability insurance?
Product liability insurance is an obligation of the manufacturer to follow all the requirements specified in Art. 10 (EU) MDR 2017/745 or Art. 10 (EU) IVDR 2017/746. The manufacturer shall always maintain during the term of the contract a product liability insurance covering the products placed on the European market. This liability insurance should include European authorized representative as well. This insurance, however, will not protect European Authorized Representative against liability that results from their unauthorized activities, wrongful or negligent acts of omission, or breach of the contract. The contract will not be valid if the manufacturer does not meet this requirement.
Does the EU Representative information need to be on the device label?
Under the MDR and IVDR, the EC Rep name and address must be on the device label; though not mandatory on the IFU. The technical documentation must contain a specimen of the label and IFU/User manual with EAR name and contact information to demonstrate traceability.
To minimize translations, place the EAR information near the EC REP symbol per EN ISO 15223-1:2016. If the label is small, use packaging or IFU. For ‘legacy’ devices under old Directives (MDD, AIMDD, IVDD), EAR info can be on the label, outer packaging, or IFU.
The European Authorized Representative information must be detailed in the Declaration of Conformity also.
What about the United Kingdom and Switzerland?
Following the United Kingdom’s withdrawal from the European Union, EU manufacturers must appoint a UK Responsible Person (UKRP) for marketing in the UK. Similarly, due to the lapse of the Mutual Recognition Agreement between Switzerland and the EU for medical devices and IVDs, the EU or UK manufacturers must appoint a Swiss Authorized Representative (CH REP) for marketing in Switzerland.
EU Representative Terms
The MDR 2017/745 and IVDR 2017/746 use the term “authorised representative” in the latest version. The EU Harmonized Standard EN ISO 15223-1 uses the term “authorized representative”, and an “EC REP” symbol is used to indicate the EU Representative. They all mean the same thing.
Role of EU Representative in case of Serious adverse events during clinical investigation
According to Art. 80 of (EU) MDR 2017/745 and Art. 76 of (EU) IVDR 2017/746, all serious adverse events must be fully recorded and immediately notified to all Competent Authorities of the Member States in which the clinical investigation is being performed by the sponsor. The European Authorized Representative should inform the manufacturer of the decisions of a Member State in respect of the refusal or restriction of the placing of the devices specified in Appendix A in the market.
What is the validity of EU Representative agreement?
Unless terminated earlier as per the agreement terms, generally, the EU-authorized representative contract shall be valid for five (5) years. The Contract will automatically renew for an additional year unless either party cancels it with written notice at least ninety (90) days before the expiration date.
EUDAMED Registration Process
The EUDAMED (European Database on Medical Devices) registration process involves several steps to ensure compliance with the European Union Medical Device Regulation (MDR) and In-Vitro Diagnostic Device Regulation (IVDR) requirements.
EU Registration Process for Medical Device and IVD,s
The 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 representative 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. The average time to register for the EU is two weeks.
Planning to change the current EU Representative? Contact us for more information