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.

Pressure Equipment

Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164);

Responsibility of an Authorised Representative - The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2) shall not form part of the authorised representative’s mandate.

An authorised representative performs the tasks that are specified on behalf of the manufacturer. The mandate must allow the authorized representative to perform at least the following tasks:

a)

Keeping the EU declaration of conformity and the technical documents available for the national market surveillance authorities for a period of 10 years after the pressure equipment or assembly has been placed on the market,

b)

Upon a justified request from a competent national authority, handover of all necessary information and documents to prove the conformity of a pressure equipment or assembly to this authority;

c)

At the request of the competent national authorities, cooperation in all measures to avert the risks associated with the pressure equipment or the assembly belonging to the area of ​​responsibility of the authorized representative.

 

Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1);

Responsibility of an Authorised Representative - The obligations under Article 4 Paragraphs 1 and 2 and the preparation of the technical documentation must not be part of the mandate of an authorised representative. An authorised representative performs the tasks that are specified on behalf of the manufacturer. The contract allows the authorised representative to perform at least the following tasks:

a)

Keeping the technical documentation available for the national supervisory authorities for at least the period specified for manufacturers in the annexes of Directive 2008/68 / EC;

b)

upon a justified request from a competent national authority, handover of all information and documents required to demonstrate the conformity of the transportable pressure equipment, in a language that can be easily understood by that competent national authority;

c)

At the request of the competent national authorities, cooperation in all measures belonging to the area of ​​responsibility to avert hazards associated with portable pressure equipment.

The identity and address of the authorised representative must be stated in the certificate of conformity in accordance with the annexes to Directive 2008/68 / EC.

The authorised representative shall only provide the operators with information that corresponds to the requirements laid down in the annexes to Directive 2008/68 / EC and the provisions of this Directive.

Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45);

Responsibility of an Authorised Representative - The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2) shall not form part of the authorised representative’s mandate.

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 EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the vessel 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 vessel;

(c)

cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by vessels covered by the authorised representative’s mandate.