Decision No 768/2008/EC of the European Parliament and of the CouncilShow full title

Article 4 Conformity assessment procedures

1. Where Community harmonisation legislation requires conformity assessment to be performed in respect of a particular product, the procedures which are to be used shall be chosen from among the modules set out and specified in Annex II, in accordance with the following criteria:

(a) whether the module concerned is appropriate to the type of product;

(b) the nature of the risks entailed by the product and the extent to which conformity assessment corresponds to the type and degree of risk;

(c) where third party involvement is mandatory, the need for the manufacturer to have a choice between quality assurance and product certification modules set out in Annex II;

(d) the need to avoid imposing modules which would be too burdensome in relation to the risks covered by the legislation concerned.

2. Where a product is subject to several Community acts within the scope of this Decision, consistency among conformity assessment procedures shall be ensured by the legislator.

3. The modules referred to in paragraph 1 shall be applied as appropriate to the product concerned and in accordance with the instructions set out in those modules.

4. For custom-made products and small series production, the technical and administrative conditions relating to conformity assessment procedures shall be alleviated.

5. When applying the modules referred to in paragraph 1, and wherever applicable and relevant, the legislative instrument may:

(a) regarding technical documentation, require information additional to that which is already stipulated in the modules;

(b) regarding the time for which the manufacturer and/or notified body are obliged to keep any kind of documentation, alter the period stipulated in the modules;

(c) specify the manufacturer's choice as to whether the tests are carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer;

(d) where product verification is performed, specify the manufacturer's choice as to whether the examinations and tests to check the conformity of the products with the appropriate requirements will be carried out, by examination and testing of every product, or by examination and testing of the products on a statistical basis;

(e) provide for the EC-type examination certificate to have a period of validity;

(f) regarding the EC-type examination certificate, specify relevant information relating to conformity assessment and in-service control to be included in it or its annexes;

(g) provide for different arrangements regarding the obligations of the notified body to inform its notifying authorities;

(h) if the notified body carries out periodic audits, specify their frequency.

6. When applying the modules referred to in paragraph 1, and wherever applicable and relevant, the legislative instrument shall:

(a) where product checks and/or verification are performed, determine the products concerned, the appropriate tests, the adequate sampling schemes, the operational characteristics of the statistical method to be applied and the corresponding action to be taken by the notified body and/or the manufacturer;

(b) where EC-type examination is performed, determine the appropriate manner (design type, production type, design and production type) and the specimens required.

7. An appeal procedure against decisions of the notified body shall be available.