§399 EC型式審査証明書

According to section 4 of Annex IX, when the outcome of the EC type-examination is positive, the Notified Body issues an EC type-examination certificate. The certificate must clearly identify the type of machinery it covers. The data necessary for identifying the approved type includes the designation of the machinery and the reference of the series or type as marked on the machinery – see §250: comments on section 1.7.3 of Annex I. If the certificate covers a type with variants, the certificate must identify these variants, indicating their distinguishing features.

It is possible to issue an EC type-examination certificate to one manufacturer for a type of machinery to be placed on the market under more than one reference or trademark. In that case, the different references and trademarks concerned shall be specified in the EC type examination certificate with an indication that they refer to the same type of machinery. If it is decided to place the machinery on the market with a different reference or trademark after the issue of the original EC type-examination certificate, the Notified Body must be informed and the certificate must be revised accordingly.

The manufacturer and the Notified Body must keep a copy of the EC type- examination certificate, the technical file for the machinery and related documents for 15 years after the issue of the certificate. This is in order to enable the Commission, the Member States or the other Notified Bodies to consult the documents according to section 7. This period of 15 years starts again each time the certificate is renewed – see §400: comments on section 9.3 of Annex IX. The duration of 15 years ensures that the documents concerned are available for the period of 10 years after the manufacture of the last unit of a series during which the manufacturer must keep the technical file for machinery available to the competent authorities – see §393: comments on Annex VII A 2. Since the Notified Body does not usually know when the last unit of the type covered by the certificate is manufactured and the certificate is valid for a period of five years, the period of custody for the EC type-examination certificate is five years longer but is counted from the date of issue of the certificate.

According to section 5 of Annex IX, if the outcome of the EC type-examination is negative, the Notified Body shall inform the applicant of its refusal to issue an EC type-examination certificate, giving the detailed reasons and indicating the procedure for appealing against the decision – see §135: comments on Article 14 (6). The other Notified Bodies and the Member State which notified the Notified Body concerned must be informed of each refusal to issue an EC type-examination certificate.

Section 6 of Annex IX requires the applicant to inform the Notified Body of any modifications he intends to make to the approved type. The Notified Body then has to decide whether or not the modification affects the validity of the EC type-examination certificate.

If the modifications are minor, the Notified Body may issue a new version or an extension of the original certificate. If the changes are liable to affect the conformity of the machinery with the relevant EHSRs, further verifications may be necessary before the new version or extension of the certificate is issued. The technical file held by the manufacturer and the Notified Body must be updated accordingly.

If the modification involves such major changes that the conformity of the machinery with the applicable EHSRs requires a new assessment, the Notified Body shall inform the applicant that the initial certificate is no longer valid for the modified type. If the manufacturer intends to continue with the modifications, he must make an application for a new EC type-examination. In general, this examination can be limited to the aspects of the machinery affected by the modifications.

According to section 7 of Annex IX, the Commission, the Member States and the other Notified Bodies may, on request, obtain from a Notified Body a copy of the certificates it has issued. On reasoned request, the Commission and the Member States may obtain a copy of the technical file and the results of the examinations carried out by the Notified Body. Notified Bodies must respond to such requests whether they are addressed by the authorities of the Member State that notified them or by the authorities of any of the other Member States. Requests for such documents may be made for the purposes of market surveillance. Such requests should indicate the nature of the doubt about the conformity of the machinery concerned and be limited to the elements that are necessary for the investigation – see §98 and §99: comments on Article 4 (3) and (4).

EC type-examination certificates do not have to accompany the machinery when it is placed on the market, but the EC Declaration of Conformity must indicate the particulars of the Notified Body which carried out the EC type-examination and the number of the EC type-examination certificate – see §383: Comments on Annex II 1 A.

Section 8 of Annex IX deals with the language of files and correspondence referring to the EC type-examination procedure other than the technical file – see §391: comments on Annex VII A. The choice of official EU language for this purpose is a matter to be agreed between the applicant and the Notified Body concerned.