1. The European Parliament. 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 (Text with EEA relevance) [Internet]. OJ L; 2017. Available from: http://data.europa.eu/eli/reg/2017/746/oj/eng.
2. The European Parliament. Directive 98/79/EC of the european parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices [Internet]. OJ L; 1998. Available from: http://data.europa.eu/eli/dir/1998/79/oj/eng.
3. The European Parliament. Regulation (EU) 2022/112 of the european parliament and of the council of 25 January 2022 amending regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices (text with EEA relevance) [Internet]. OJ L; 2022. Available from: http://data.europa.eu/eli/reg/2022/112/oj/eng.
4. MedTech, Europe. Analysing the availability of IVDs in May 2022 [Internet - cited 2022 Aug 24]; 2022. Available from: https://www.medtecheurope.org/resource-library/medtech-europe-survey-report-analysing-the-availability-of-in-vitro-diagnostic-medical-devices-ivds-in-may-2022-when-the-new-eu-ivd-regulation-applies/.
5. European Commission. New Approach Notified and Designated Organisations. [Internet - cited 2022 Aug 18]; 2022. Available from: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35.