Authorised Representative
Manufacturers of regulated products, including medical devices, in vitro diagnostic (IVD) medical devices, cosmetics, toys, pressure equipment, and low voltage electrical equipment, must comply with EU and UK regulatory requirements when placing products on these markets. Manufacturers established outside the EU or UK may be required, under applicable EU regulations, EU directives, or UK legislation, to appoint an Authorised Representative or Responsible Person, depending on the product and market.
International Associates Limited provides Authorised Representative and Responsible Person services for both the European Union and the United Kingdom, supporting manufacturers with local regulatory representation and ongoing compliance obligations.
Headquartered in the UK, with an Irish subsidiary, we are able to act as your representative in the EU or UK, supporting a range of regulatory scenarios, including those arising from post-Brexit regulatory frameworks.
As regulatory obligations vary by product category, each product type is subject to specific requirements. Further information for selected products is provided below, and we are happy to advise on additional product types upon request.
OTHER PRODUCTS COVERED
- Foods
- Pressure Equipment
- PPE Personal Protective Equipment
- Marine Equipment
- Etc
RESPONSIBILITIES EU AUTHORIZED REPRESENTATIVE AND UK RESPONSIBLE PERSON
The EU Authorized Representative and UK Responsible Person roles are generally similar however they do vary according to the product type and the relevant Articles of the applicable Directives or Regulations.
This would usually include:-
- Review of the Technical File or Product Information File and associated documentation and labelling
- Registration of the product with the relevant regulatory authority
- Audit support in case of a request by the regulator authority
- Vigilance reporting and monitoring
- Compliance; including holding the documentation for the required period.
- Cooperate with the Regulatory authority requests.
See our product-specific pages for detailed information.
CHANGE YOUR AUTHORIZED REPRESENTATIVE.
First of all, this change should appear in the agreement between the manufacturer and the Authorized Representative (Outgoing and incoming).
To be compliant, the manufacturer should address the following aspects:
- The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.
- The date until which the manufacturer can show the outgoing AR on the information or promotional material.
- The transfer of documents, including confidentiality aspects and property rights
- The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from users about suspected incidents related to the product.