Authorized Representative for General Product Safety (GPSD)
Manufacturers placing product on the EU or UK market have specific obligations under the EU Directives and UK Regulations. These include appointing and Authorized(where the manufacturer is not established in the EU or UK)
EU requirements: Directive 2001/95/EC on General Product Safety (the “GPSD”) aims to ensure that only safe products are made available to consumers. It defines a number of requirements for Manufacturers and distributors of products to ensure that products are safe, consumers are informed of any risks associated with products and dangerous products can be removed.
UK requirements: The UK’s General Product Safety Regulations 2005/1803 (the “GPSR”) aims to ensure that only safe products are made available to UK consumers. This defines a number of requirements for Manufacturers and distributors of products to ensure that products are safe, consumers are informed of any risks associated with products and dangerous products can be removed.
Different rules apply to goods you sell in: (1) Great Britain (England, Scotland and Wales) and (2) Northern Ireland.
It is the manufacturer’s responsibility to comply with the GPSR when selling products in the UK, including if you are selling online directly or via through fulfilment centre. (Such as Amazon or Ebay).
What products are in the scope of the GPSR and GPSD?
Both the GPSD and GSPR apply to any new, used, or reconditioned product that is intended for consumers or those where it is reasonably foreseeable that consumers may use it. This includes products supplied or made available in the course of a commercial activity, including in the context of providing a service.
They also applies to products that come within the scope of sector specific EU legislation (see our other pages on specific product such as Toys, Low Voltage equipment, Cosmetics etc.).
Exceptions to the scope are specific higher risk products ie pharmaceuticals, medical devices, and food as these product types fall under separate legislation. (again see our other pages relative to these products)
Changing your Authorized Representative.
Changing your Authorized Representative is a fairly straightforward process. 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.