Manufacturers must comply with the essential requirements of the European Toy Safety Directive (TSD) 88/378/eec, or the UK Toys (Safety) Regulations 2011.
International Associates Limited is able to act as your Authorized Representative in both Europe and also within the UK.
Toy Safety Standards cover mainly:
- Mechanical & Physical Hazards
- Toxicity-Migration of Certain Elements
- Experimental Sets for Chemistry
- Chemical Toys
- Graphical Symbol for Age Warning
- Electrical properties
If a manufacturer is from outside the EU or UK, then the manufacturer needs to appoint a European Authorized Representative to complete the mandatory tasks.
The name and address of the European Authorized Representative must be printed on the labelling and package of toys along with the CE / UKCA marking.
The Authorized representative shall perform at least the following tasks:
- Keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of 10 years after the toy has been placed on the market;
- Further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a toy;
- Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by toys covered by the mandate.
Guidance on the regulations for the UK and Northern Ireland can be found here
And guidance for the EU can be found here
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.