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Health institution exemptions for MDR/IVDR

Published on 31 March 2020

Health boards and local authorities are no longer automatically exempt from the Medical Devices Regulations (MDR) and In Vitro Diagnostic Devices Regulations (IVDR).

These changes have an impact on all NHS boards and local authorities and will come into effect on 26 May 2020 for MDR and May 2022 for IVDR.

Activities that are no longer exempt

Most health boards and local authorities in Scotland carry out activities which can be considered to be manufacturing or modifying a device.

These activities include (but are not limited to):

  • making a new device from used devices
  • rebuilding an existing device
  • refurbishing a device
  • using a product for a medical purpose that is not CE marked (certified) as a device
  • modifying a device for a new purpose
  • using an existing device for a different purpose to that intended by the manufacturer

Under the new regulations, health institutions must apply for exemption before carrying out these activities. Otherwise, they must comply with regulations for medical and in vitro devices.

How to apply for the exemption

To apply for the exemption, you must:

  • ensure products meet safety and performance requirements
  • have a quality system in place
  • give a reason for why you are applying
  • have technical documentation in place
  • ensure certain information is publicly available

For more information, visit the GOV.UK website.