The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies
Produced in partnership with Alison Dennis of Taylor Wessing LLP

The following Life Sciences practice note produced in partnership with Alison Dennis of Taylor Wessing LLP provides comprehensive and up to date legal information covering:

  • The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies
  • Devices that fall within the scope of the MD Regulations
  • Medical devices
  • In vitro diagnostic medical devices (IVDs)
  • Devices without an intended medical purpose
  • Devices with dual purpose and borderline products
  • Drug/device combinations
  • Accessories
  • Specifically designated products
  • Exclusions
  • More...

The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies

This Practice Note examines the scope and classification of devices under Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), conformity assessment procedures and designation and monitoring of Notified Bodies.

For information on:

  1. key provisions of the MDR and IVDR, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

  2. clinical evaluation and investigation of devices, see Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU

  3. post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the EU

  4. European database on medical devices (EUDAMED) and the obligations of economic operators, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators

Devices that fall within the scope of the MD Regulations

Medical devices

General and active implantable medical devices (AIMDs) both fall within the scope of the MDR.

Article 2(1) of the MDR expands the definition of a ‘medical device’ to:

‘…any instrument, apparatus, appliance, software, implant, reagent, material or other article, which is intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  1. diagnosis, prevention, monitoring, prediction, prognosis,

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