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Medical devices

The Healthcare Inspectorate oversees the quality and usage of medical devices. A ‘medical device’ is any product other than a pharmaceutical that is used for medical purposes. Examples range from a simple sticking plaster to a pacemaker or surgical instruments.

The classification also covers the software that some products require in order to work properly. One notable group of medical devices is that of the in-vitro diagnostic tests, such as those used to determine pregnancy or HIV infection.

The Inspectorate ensures that the manufacturers and suppliers of medical devices observe all relevant legislation, and takes action in the event of a breach of the regulations. The Inspectorate evaluates all incoming reports about malfunctions or quality issues relating to medical devices. It also oversees the activities of DEKRA Certification, the ‘notified body’ for the Netherlands.

All countries have a notified body, being the independent, government-approved testing and certification organization which verifies whether medical devices meet all quality requirements and the specifications laid down by law. A manufacturer may choose which of the European notified bodies is to inspect and assess its products. The Inspectorate also ensures that manufacturers fulfil the legal requirement of notifying certain groups of medical devices to the CIBG, an agency of the Ministry of Health which maintains the various registers.

Legislation

  • Medical Devices Act
  • Medical Devices Decree
  • Active Implants Decree
  • In-vitro Diagnostics Decree

Medical devices are also governed by a number of EU Directives

  • Directive on Standards for Active Implantable Medical Devices (90/385/EEC)
  • Directive on Medical Devices (93/42/EEC)
  • Directive on in-vitro diagnostic medical devices for (98/79/EC)

Various sets of guidelines (‘MEDDEVs’) have been compiled to facilitate the implementation and interpretation of the legislation and can be found on the European Commission’s website.

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