Secure storage for your technical files

 Regulation 2019/1020 on market surveillance identifies the following Directives and Regulations in Annex I. Products within this list require technical information to be held by an importer, fulfilment centre or Authorised Representative to be able to continue to supply the product or good into the EU from July 16th 2020. The Directive and Regulation list is below, with Authorised Representative duties identified. 

Please Note: We do not act as Authorised Representative for Medical Devices Directives or WEEE.

The manufacturer remains responsible for the safety and compliance of the machinery or products supplied.

Toys

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1);

 1.  A manufacturer may, by a written mandate, appoint an authorised representative.

2.  The obligations laid down in Article 4(1) and the drawing up of technical documentation shall not form part of the authorised representative’s mandate.

3.  An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a) 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;

(b) 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;

(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by toys covered by the mandate.

As Toys are often small volume and low price, the cost of the service will depend on the complexity of the Technical Documentation. There is a cost to store the Technical Documentation which will be €100 per Technical File, and a cost to review it which will be based on amount of documentation. The annual fee remains at €300.

In the first instance, please contact derek@holdtechfiles.eu, with a sample of documentation for a single product. We will then arrange a proposal.

Toys contribute to child development and play is an essential part of growing up. However, toys have to be safe for children to play with. Ensuring that toys marketed in the EU do not put children at risk is a priority. EU legislation aims to ensure that toys meet safety requirements that are amongst the strictest in the world, especially in relation to the use of chemicals in toys.

The scope of the 2009 Toy Safety Directive is covered by Article 2. It provides a definition for toys and therefore determines whether a product falls under the scope of the Directive:

“Any product or material designed or intended whether or not exclusively for use in play by children under 14 years of age”.

Each toy to be placed on the market is submitted to a conformity assessment procedure. Details as to who must  undertake the procedure and how it is done are provided in the 2009 Toy Safety Directive. A brief overview is set out below.

Objective of conformity assessment

The objective of the conformity assessment procedure is to demonstrate to the manufacturer and the public authorities that a toy placed on the market complies with the legal requirements of the 2009 Toy Safety Directive.

Definition of conformity assessment

Conformity assessment is the procedure by which a manufacturer establishes that his toy fulfills the applicable safety provisions of the directive.

The manufacturer is required to apply one of two possible procedures depending upon the nature of the toy:

1. Self verification

Self verification is used in cases where harmonized standards cover all relevant safety aspects of a toy. In such instances, the manufacturer must apply the existing harmonized standards and ensure that the toy is in conformity 
therewith. The manufacturer must also put in place an internal production procedure in accordance with Module A of Annex II to Decision No. 768/2008/EC. Module A does not require the involvement of a notified body.

2. Third party verification

Conformity to type or Module B is often referred to as “EC-type examination”.
EC-type examination and certification is required in cases where:
• harmonized standards do not exist;
• harmonized standards have not or only partly been applied by a manufacturer;
• one or more harmonized standards have been published with a restriction; or • the manufacturer considers that the nature, design, construction or purpose of the toy requires third party verification.
In such cases a manufacturer submits a model of the toy to a notified body for EC-type examination. Under Module B, the notified body examines the technical design of a toy and verifies and attests that the technical design of the toy meets the requirements of the 2009 Toy Safety Directive by issuing an EC-type examination certificate.

It is important to note that Module B covers the design phase only, whereas Module C covers the production phase and follows Module B. Under Module C, the manufacturer ensures the conformity of the toys with the type described in the EC-type examination certificate and with the relevant requirements of the legislative instrument that apply. This conformity is evaluated against an approved EC-type examination certificate issued under Module B. Unlike Module B, Module C does not require the involvement of a notified body. Difference between safety assessment and conformity assessment.

The objective of the safety assessment is to identify the potential hazards of a toy, as well as to assess the potential exposure to those hazards. The conformity assessment procedure, on the other hand, is to provide demonstrable evidence that the toy is in conformity with the legal requirements under the 2009 Toy Safety Directive. In general, the safety assessment is drawn up before submitting the toy to the appropriate conformity assessment procedure (although it may be completed at a later stage) and must be completed before the toy is placed on the market.