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Conversion of new machinery directive 2006/42/EC Q&A

Conversion of new machinery directive 2006/42/EC Q&A

ards and ensure that the current standards are checked against Directive 2006/42/EC and adapted as necessary. Furthermore, all harmonised standards must include a reference to the new Directive.

The Commission intends to publish a list of harmonised standards supporting Directive 2006/42/EC before the Directive becomes applicable.

5. Question:When will manufacturers be able to use the new full quality assurance procedure for Annex IV machinery?

Answer:The Member States will first have to assess, appoint and notify Notified Bodies for the new full quality assurance procedure set out in Annex X of the new Directive. This can be done as soon as Directive 2006/42/EC has been transposed into national law.

As soon as Bodies have been notified for this procedure, they will be able to carry out the necessary audits and inspections and issue approvals of manufacturers’ full quality assurance systems.

However, products cannot be placed on the market on the basis of such approvals until Directive 2006/42/EC becomes applicable on 29th December 2009.

6. Question:Will the existing Notified Bodies be able to carry out EC type-examinations according to Directive 2006/42/EC?

Answer:Bodies that are notified to carry out EC type-examinations under Directive 98/37/EC will be able to continue to carry out EC type-examinations under Directive 2006/42/EC, providing their notification covers the product categories concerned.

For product categories included in Annex IV of Directive 2006/42/EC that are not listed in Annex IV of Directive 98/37/EC, the Member States will have to notify new Bodies or extend the scope of the notification of existing ones.

7. Question:Will EC type-examination certificates established according to Directive 98/37/EC remain valid for Directive 2006/42/EC?

Answer:Since there have been some modifications to the essential health and safety requirements set out in Annex I, it cannot be assumed that EC type-examination certificates issued according to Directive 98/37/EC remain valid for Directive 2006/42/EC. Furthermore, such certificates must be d to refer to Directive 2006/42/EC..

Notified Bodies will thus have to review existing EC type-examination certificates to ensure that they remain valid in light of the requirements of the new Directive and them to refer to Directive 2006/42/EC. Manufacturers are encouraged to request this review without delay in order to avoid a bottleneck in the months preceding December 2009.

Since Directive 2006/42/EC requires EC type-examination certificates to be reviewed every 5 years see Annex IX, section 9.3, the 5-year period for existing certificates can be counted from the date on which they have been d according to Directive 2006/42/EC.

8. Question:What will happen to products certified according to one of the procedures set out in Article 8 2 c of Directive 98/37/EC Receipt of techncial file or Certificate of adequacy to harmonised standards?

Answer:The procedures set out in Article 8 2

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