Biocompatibility: MDR and EN ISO 10993-1:2018

The medical device industry in Europe will experience a major change in the upcoming years due to the implementation of the new Medical Device Regulation (MDR), to become applicable in May 2020.

The biocompatibility of materials will be a principal challenge to be faced. The compliance with the MDR will converge to the approach settled by the new version of the harmonized standard EN ISO 10993-1:2018 for Biological Evaluation of medical devices. Both documents show the necessary requirements to check the safety of medical devices composition in contact with patient’s body or user’s body in case the device is intended for protection.

What does this new standard say?

The main specifications of EN ISO 10993-1:2018  are:

  • The assessment of the biological safety of a medical device
  • The general principles of the biological evaluation within a risk management process
  • Medical device classification
  • The identification of gaps in the available data within a risk management process

Obelis can help you

Do you want to be ready for the new Medical Device Regulation? Are you interested in expand your business selling in Europe? We guide companies around the world to comply to the European standards, please contact us through our website and check our next exhibition!

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Victor Pastor Martin

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