CE marking refurbished or modified machinery

Refurbished or modified machinery (fixed installations) are subjected to re-evaluation of the CE marking and its certification. Whether it is necessary to re-certify a modified or refurbished machinery depends on the extent of the modifications made and the specific regulatory requirements.

The Situations for refurbished or modified machinery

.The extent of the changes made to the original machinery, together with its provenance, can result in the following situations:

  • Add additional information to the technical file
  • Re-certification or Re-assessment

Add additional information to the technical file

Originally compliant and CE marked machinery that is refurbished and/or where parts are replaced with new similar versions do not require re-certification or re-assessment. If modifications are made to a machinery which are minor and do not affect its compliance with the essential safety requirements of the applicable EU directives, re-certification or re-assessment may also not be necessary. However, it is essential to thoroughly assess the impact of the modifications to ensure that they do not compromise safety. Furthemore, all modifications and refurbishment actions must be documented and added to the technical file for the machinery.

Re-certification or Re-assessment

In cases where the product is substantially rebuilt, it could be considered as new machinery and thus be subject to the conformity assessment and CE marking requirements of the Machinery Directive. Therefore, changing to a substantially different safety strategy requires re-certification or re-assessment to ensure compliance with the Machinery Directive.

To give an example: The substitution of fixed fencing and interlocked doors with new laser scanning safety systems requiring additional associated control units, will probably require re-compliance with the Machinery Directive before the machinery is placed on the market or put back into service.

Here are some general guidelines when you re-certify or re-assess your machinery:

  • Assessment and Documentation: Manufacturers or refurbishers should conduct a risk assessment to determine the impact of the modifications on safety. If the assessment indicates that the machinery no longer complies with the applicable directives, it may be necessary to follow the relevant conformity assessment procedure and update the technical documentation accordingly.
  • Conformity Assessment: Depending on the circumstances, the conformity assessment procedure may involve internal production control, EU-type examination, or other methods specified in the directive. The choice of assessment method will depend on the nature and scope of the modifications.
  • Notified Body Involvement: In some cases, where significant modifications are involved, the involvement of a notified body (third-party certification body) for assessment and certification may be required, particularly if the machinery was originally certified with notified body involvement.
  • CE Mark and Declaration of Conformity: If the machinery passes the assessment and is found to comply with the applicable safety requirements, it should bear the CE mark, and a new Declaration of Conformity (DoC) should be prepared to reflect the updated status.

Conclusion

It’s important to note that the specific requirements for re-assessing and re-certifying modified or refurbished machinery can vary depending on the applicable EU directives, the extent of modifications, and the type of machinery involved. Therefore, it is advisable to seek guidance from experts in machinery safety and regulatory compliance to ensure that the modified or refurbished machinery complies with all necessary requirements. Therefore, please do contact us, if we can be of any service.

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