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:
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:
key provisions of the MDR and IVDR, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
clinical evaluation and investigation of devices, see Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU
post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the EU
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
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:•diagnosis, prevention, monitoring, prediction, prognosis,
‘…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:
diagnosis, prevention, monitoring, prediction, prognosis,
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