References

[1] Regulation 2017/746 of the European Parliament and the Council: REGULATION (EU) 2017/ 746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 5 April 2017 - on in vitro diagnostic medical devices and repealing Directive 98/ 79/ EC and Commission Decision 2010/ 227/ EU (europa.eu)

[2] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) 
EUR-Lex - 02017R0745-20200424 - EN - EUR-Lex (europa.eu) 

[3] MDR Article 2 Definitions – Medical Devices regulation https://www.medical-device-regulation.eu/2019/07/10/mdr-article-2-definitions/