Haelvoet blog

26-05-20 Products

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MDR Compliance

We are proud to inform you that Haelvoet completed the implementation of the new EU Medical Device Regulation (MDR) despite the postponement by the European commission by one year to May 26th 2021.

As of today, all Haelvoet Class 1 medical devices are MDR compliant. This essentially means that:

• All product manuals have been updated
  
• Haelvoet products carry the prescribed CE-label and have a CE-certification with basic UDI device identifier (UDI-DI).
  
• Each product has an identification label with model designation, date of manufacture and a barcode label with the specific UDI device identifier (UDI-DI).
  
• EN ISO 9001 and EN ISO 13485 certification are available for our medical devices. Haelvoet, however, has already been voluntarily applying these quality management systems for many years.
  
• Procedures regarding incident handling and registration have been put in place.
  
• Post market surveillance after releasing products has been implemented.
  

Thanks to the MDR, the medical industry becomes safer, more transparent and more reliable. Values that are of great importance to us.

Please note that all Haelvoet manuals and CE-certifications dated before May 26th 2020 expire. You can find the most recent version of all these documents on our website.
Please contact us if you want more information about this (info@haelvoet.be).