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EU: Standards for manufacturers of medical devices (COVID-19)

EU: Standards for manufacturers of medical devices

The European Commission (EC) adopted decisions on harmonised standards for manufacturers of medical devices.

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As noted in an EC release (25 March 2020), the standards will facilitate a faster and less expensive conformity assessment procedure and will play a pivotal role in the current coronavirus pandemic because they relate to critical devices such as:

  • Medical face masks
  • Surgical drapes, gowns and suits
  • Washer-disinfectors
  • Sterilisation

European rules for medical devices rely on harmonised standards. In particular, under the three current directives on medical devices, there are about 300 harmonised standards conferring presumption of conformity with the legal essential requirements.

The updated and harmonised standards will apply for important medical protective equipment, like face masks and single-use gloves, to allow companies to start producing these items.

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