If you are a manufacturer of Products including; Medical Devices, Cosmetics, Toys, Pressure Equipment, Low Voltage Equipment etc. and you are based outside the EU or UK you are required under the EU directives or UK Legislation to appoint an Authorized Representative or Responsible Person.
International Associates Limited is able to act as your Authorized Representative or Responsible Person in both Europe and also within the UK.
Based in the UK with its Irish subsidiary we are able to offer the service of operating as your Representative in either the EU or the UK, covering any scenario relating to Brexit.
Each product has its own specific requirements, therefore we have detailed some additional information relating to various products below, and are happy to provide more details on other product types.
Other Products Covered
Low Voltage Equipment
PPE Personal Protective Equipment
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.
Changing 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 healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.