Authorized representative of medical device manufacturers
The authorised representative of medical device manufacturers shall be any natural or legal person established in the Union; that you have received and accepted a written mandate from a manufacturer. That manufacturer shall be located outside the European Union to act on its behalf in relation to specific tasks as regards its obligations under the MDR Regulation.
PS Consulting, as an authorised representative of medical device manufacturers, shall ensure that devices placed on the Union market comply with the following regulatory requirements:
- Verify that the EU declaration of conformity and the technical documentation of the product have been prepared.
- To keep a copy of the technical documentation available to the competent authorities; the EU declaration of conformity and, where appropriate, a copy of the corresponding certificate.
- Comply with the obligations of registration with EUDAMED and verify that the manufacturer has also complied with it.
- Provide all the information and documentation necessary to demonstrate the conformity of the product to the competent authorities, upon request.
- Transmit to the manufacturer any request for samples or access to a product by a competent authority.
- Cooperate with the competent authorities in any preventive or corrective action that is adopted.
- Immediately notify the manufacturer of complaints and reports from health professionals related to the product.
Needs
The designation as an authorized representative will be established by a contract signed by the manufacturer of the medical device and PS Consulting. This contract will establish the obligations of both parties.
At PS Consulting we will be happy to help introduce safe and effective medical devices to the EU market.
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