Questions about Medical Device Authorized Representative
AF Pharma: Authorized Representative for Medical Devices
Q: Who does AF Pharma work with as an Authorized Representative for medical devices?
A: AF Pharma works with clients from different countries as an Authorized Representative for medical devices.
Q: Who is obliged to appoint an Authorized Representative?
A: A manufacturer established outside the European Union is obliged to appoint an Authorized Representative.
Q: What are the responsibilities of an authorized EU representative?
A: The responsibilities of an authorized EU representative include:
Keeping the technical documentation or declaration of conformity available for inspection by the authorities of the Member States upon request.
Ensuring that the product is correctly labeled.
Responding in case of a medical incident.
Registering the product in the relevant office.
Taking part in safety corrective actions (FSCA).
Q: How should you choose an independent authorized representative?
A: When choosing an independent authorized representative, consider the following:
The authorized representative should be an independent organization acting in agreement with the manufacturer.
Distributors in your distribution network may not have expertise in legal requirements, so it is advisable to choose a separate authorized representative.
The authorized representative should have access to the full technical documentation, including information on the project.
They should be kept informed of any changes in legal regulations and warn your company in advance.
The authorized representative should be able to represent the manufacturer adequately and answer all questions from the Competent Authorities.
The authorized representative's information should be included in all information materials such as labels, packaging, and instructions for use.
Q: What are the obligations of the authorized representative in the EUDAMED database?
A: After the EUDAMED database becomes fully functional, economic operators, including authorized representatives, should register in this electronic system. Each authorized representative fulfilling the obligations mentioned in the MDR will obtain a single registration number (SRN) and can be verified in a public database.