Representative Services
Are you planning to conduct a Clinical Investigation Study in Europe or are you seeking to obtain or renew your CE- certification to sell your MD’s in Europe?
If your company does not have a physical location in Europe, according to EU 2017/745 MDR, you are required to appoint a Legal Representative and an Authorized Representative to represent your company towards the EU authorities.
EU Authorized Representative according to Art. 11 EU 2017/745 MDR
What is the role of the EC REP?
The European Authorized Representative will be the liaison between you and the Competent Authorities and will be responsible for;
Review, and maintain a current copy of your Technical File or CE Declaration of Conformity and make it available for inspection by a Competent Authority, when required.
Ensure compliance of specific Medical Device registrations, and conformity of the Medical Device.
Be identified on your Medical Device labeling throughout Europe.
Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributors if applicable.
Why choose TRIQ as your EU Authorized Representative?
Your EC REP must, not only have the presence but must have extensive knowledge and experience with Medical Device Regulatory Affairs and the related communication with the relevant authorities.
Our experienced consultants will review your Technical File, register your medical device and respond to any questions or concerns from the Competent Authorities.
You will have secure online access to all your documentation and regulatory information, including technical files, labeling information and symbols, language requirements, directives, guidelines, and more.
Our vast expertise with European regulations & registering Medical Devices facilitates a smooth and efficient registration process.
TRIQ informs it’s clients of any relevant critical regulatory updates in Europe.
Each project has it’s unique requirements, contact TRIQ to get more information and find out where we can support your needs.
Questions and Answers
Your Notified Body requires the appointment of an EC REP before they will issue a CE-certificate. Competent Authorities require the same to authorize a Clinical Investigation Study. Compliance with the applicable Directive is mandatory for any Medical Device placed in the EU market; therefore, engaging and identifying your chosen representative is essential. If you do not appoint an EC REP, the Authorities may stop your products at the border.
Yes. A Competent Authority can inspect an Authorized Representative at any time to determine if they understand their role. The CA will also check that the EC REP has direct access to client documentation such as the Technical File/Design Dossier and have processes in place to ensure it can fulfill its role as an EU Authorized Representative.
Yes. You must list the name and address of the EU Authorized Representative on the product label, outer packaging and Instructions for Use.
Authorized Representatives will take on more risk and liability under Europe’s new Medical Device Regulation (MDR). EU Authorities will hold the EC REP jointly and severally liable for defective Medical Devices, so you can be sure that your authorized representative will monitor your compliance thoroughly.