Annex IX of machinery directive 2006/42/EC - EC type-examination

The text in RED color is the amended or added text in comparison with the former 98/37/EC machinery directive.

ANNEX IX : EC type-examination

EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative model of machinery referred to in Annex IV (hereafter named the type) satisfies the provisions of this Directive.

1. The manufacturer or his authorised representative must, for each type, draw up the technical file referred to in Annex VII, part A.

2. For each type, the application for an EC type-examination shall be submitted by the manufacturer or his authorised representative to a notified body of his choice.

The application shall include:

- the name and address of the manufacturer and, where appropriate, his authorised representative,

- a written declaration that the application has not been submitted to another notified body,

- the technical file.

Moreover, the applicant shall place at the disposal of the notified body a sample of the type. The notified body may ask for further samples if the test programme so requires.

3. The notified body shall:

3.1. examine the technical file, check that the type was manufactured in accordance with it and establish which elements have been designed in accordance with the relevant provisions of the standards referred to in Article 7(2), and those elements whose design is not based on the relevant provisions of those standards;

3.2. carry out or have carried out appropriate inspections, measurements and tests to ascertain whether the solutions adopted satisfy the essential health and safety requirements of this Directive, where the standards referred to in Article 7(2) were not applied;

3.3. where harmonised standards referred to in Article 7(2) were used, carry out or have carried out appropriate inspections, measurements and tests to verify that those standards were actually applied;

3.4. agree with the applicant as to the place where the check that the type was manufactured in accordance with the examined technical file and the necessary inspections, measurements and tests will be carried out.

4. If the type satisfies the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer and his authorised representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject.

The manufacturer and the notified body shall retain a copy of this certificate, the technical file and all relevant documents for a period of 15 years from the date of issue of the certificate.

5. If the type does not satisfy the provisions of this Directive, the notified body shall refuse to issue the applicant with an EC type-examination certificate, giving detailed reasons for its refusal. It shall inform the applicant, the other notified bodies and the Member State which notified it. An appeal procedure must be available.

6. The applicant shall inform the notified body which retains the technical file relating to the EC type-examination certificate of all modifications to the approved type. The notified body shall examine these modifications and shall then either confirm the validity of the existing EC type-examination certificate or issue a new one if the modifications are liable to compromise conformity with the essential health and safety requirements or the intended working conditions of the type.

7. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC type-examination certificates. 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.

8. Files and correspondence referring to the EC type-examination procedures shall be written in the official Community language(s) of the Member State where the notified body is established or in any other official Community language acceptable to the notified body.

9. Validity of the EC type-examination certificate

9.1. The notified body has the ongoing responsibility of ensuring that the EC type-examination certificate remains valid. It shall inform the manufacturer of any major changes which would have an implication on the validity of the certificate. The notified body shall withdraw certificates which are no longer valid.

9.2. The manufacturer of the machinery concerned has the ongoing responsibility of ensuring that the said machinery meets the corresponding state of the art.

9.3. The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years.

If the notified body finds that the certificate remains valid, taking into account the state of the art, it shall renew the certificate for a further five years.

The manufacturer and the notified body shall retain a copy of this certificate, of the technical file and of all the relevant documents for a period of 15 years from the date of issue of the certificate.

9.4. In the event that the validity of the EC-type examination certificate is not renewed, the manufacturer shall cease the placing on the market of the machinery concerned.

Comment: A IX -1

This appendix is the one that was set out in Annex VI of the Machinery Directive 98/37/EC. The content of this Annex has been reformulated and clarified to define the respective responsibilities of notified bodies and manufacturers.

It applies only in the case of machinery and safety components " referred to Annex IV which are not manufactured in accordance with harmonized standards or only manufactured in part , or if the harmonized standards do not cover all the relevant essential requirements health and safety, or if no harmonized standards for the related machine exists " .

The main additions compared to the old Directive 98/37/EC are:

2 - a written declaration that the application has not been submitted to another notified body 

"the old directive stated that " The application for EC type-examination shall be lodged by the manufacturer or by his authorised representative established in the Community, with a single notified body in respect of an example of the machinery."

the applicant shall place at the disposal of the notified body a sample of the type ...

the old directive stated " It shall be accompanied by a machine representative of the production planned or, where appropriate, a statement of where the machine may be examined. "

3 - paragraph 3 has been completely rewritten to take into account certain clarifications of the Machinery Directive 89/392/EEC and 98/37/EC as regards concerning the conditions of acceptance of test results by other notified or accredited bodies according to ISO 17025 (formerly EN 45001) . The old directive specified in paragraph 3 c) " conduct the necessary examinations and tests to check the conformity of the machinery with the essential requirements of safety and health concerning ." The text of the new directive was changed to " 3.2. carry out or have carried out appropriate inspections, measurements and tests to ascertain whether the solutions adopted satisfy the essential health and safety requirements of this Directive, where the standards referred to in Article 7(2) were not applied "

4 - The retention period of documents has been set at 15 years. This is the time beyond which the Community authorities may no longer request a notified body or manufacturer information on the certified machine. Although because of the limited duration of the certificates (see chapter 9 below ) , this documentation is in fact preserved 10 years after the end of validity of the certificate of EC type examination.

7 - On reasoned request, ONLY the Commission and the Member States may obtain a copy of the technical file and the results of examinations conducted by the notified body. In the old Machinery Directive 98/37/EC , notified bodies could also obtain a copy of these documents.

9 - Major changes :

9.1 - Notified Bodies are responsible for the EC type examination certificates they issue. They must inform the manufacturers of the major changes are in most cases changes or evolutions of standards and the state of harmonized standards.
9.2 - Manufacturers must also check the state of the art that is defined in ...  the harmonized standards.
9.3 - EC type examination certificate is only valid for FIVE years and is renewed every 5 years period.

Original comment : A IX-1

Cette annexe est celle qui était définie à l’annexe VI de la directive machines 98/37/CE.  Le contenu de cette annexe a été reformulé et précisé pour définir les responsabilités respectives des organismes notifiés et des fabricants.

Elle s’applique dans le cas des seules machines et composants de sécurité « visée à l'annexe IV qui ne sont pas fabriquées conformément aux normes harmonisées ou seulement en partie, ou si les normes harmonisées ne couvrent pas l'ensemble des exigences essentielles de santé et de sécurité pertinentes, ou s'il n'existe pas de normes harmonisées pour la machine en question ».

Les principaux compléments par rapport à l’ancienne directive 98/37/CE sont :

2 - une déclaration écrite … l’ancienne directive mentionnait que « La demande d’examen «CE» de type est introduite par le fabricant, (…)  auprès d’un seul organisme notifié »

le demandeur tient un échantillon du type … l’ancienne directive mentionnait « Elle est accompagnée d’une machine représentative de la production envisagée … »

3 – le paragraphe 3 a été complètement reformulé afin de prendre en compte certaines clarifications de la directive machine 89/392/CE et 98/37/CE pour ce qui est relatif aux conditions d’acceptation de résultats d’essais par d’autres organismes notifiés ou accrédités selon le référentiel ISO 17025 (anciennement EN 45001). L’ancienne directive précisait au paragraphe 3 c) « effectue les examens et essais appropriés pour vérifier la conformité de la machine aux exigences essentielles de sécurité et de santé la concernant ». Le texte de la nouvelle directive a été modifié en « 3.2. effectue ou fait effectuer les contrôles, mesures et essais appropriés »

4 – La durée de conservation des documents a été fixée à 15 ans. Il s’agit de la durée au delà de laquelle les autorités communautaires ne peuvent plus demander à un organisme notifié ou un fabricant d’informations sur la machine certifiée. Quoique du fait de la durée limitée des attestations (Cf. chapitre 9 ci-après), cette documentation est dans les fait conservée 10 ans après la fin de validité de l’attestation d’examen CE de type.

7 – sur demande motivée, SEULS la Commission et les États membres peuvent obtenir une copie du dossier technique et des résultats des examens effectués par l'organisme notifié. Dans l’ancienne directive machines 98/37/CE, les organismes notifiés pouvaient également obtenir une copie de ces documents.

9 - Grands changements : 

• 9.1 - les organismes notifiés sont garants des attestations d’examen CE d type qu’ils émettent. Ils doivent informer les fabricants des changements importants qui sont dans la majorité des cas des modifications ou évolutions normatives et de l’état des normes harmonisées.
• 9.2 - Les fabricants doivent également surveiller l’état de la technique qui est défini dans … les normes harmonisées
• 9.3 - l’attestation d’examen CE de type n’est valable que CINQ ans et est renouvelée par période de 5 ans.