Regulation of Medical Devices

KTS logo 2 300px by 217px with shadow and textMedical devices are regulated in member states of the EU and EFTA by three directives:

  • Directive 90/385/EEC regarding active implantable medical devices.
  • Directive 93/42/EEC regarding medical devices
  • Directive 98/79/EC regarding in vitro diagnostic medical devices

These directives give definitions of what is considered a medical device. Compliance with many aspects of these directives is achieved most easily by compliance with the relevant standards. For example the quality system requirement is met by compliance with;

  • ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
  • ISO 14971 Medical devices – Application of risk management to medical devices
  • ISO 10993 Biological evaluation of medical devices