Note that the Union includes Turkey, Iceland, Liechtenstein, and Norway.
https://medicaldeviceslegal.com/2023/03/20/mdr-and-ivdr-amendment-has-entered-into-force-now/
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2023.080.01.0024.01.ENG&toc=OJ%3AL%3A2023%3A080%3ATOC
