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NEW EU REGULATION FOR MEDICAL PRODUCTS VALID FROM MAY 2020

The new EU Medical Device Regulation 2017/745 entered into force on May 25, 2017 and will apply from May 26, 2020 after a three-year transition period. The guideline can be viewed at https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32017R0745. This directive replaces the previous directive 93/42 / EEC on medical devices. It applies immediately and does not require implementation in national laws.

Our brushes, which are used to clean medical devices, are then class I medical devices. In our role as suppliers, it is our aim to provide our customers with the best possible care. We would be happy to provide you with information, data sheets, test plans, etc. that you need to implement the new directive.

This applies in particular to

  • Endoscope cleaning brushes
  • Cleaning brushes in the hospital for
    • hoses
    • valves
    • Distal valves
    • working channels
  • Dental and interdental brushes with elbow (mandrill)

You can find more information on the website of the Federal Ministry of Health.

https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32017R0745