The medical devices listed in this section are medical devices within the meaning of Article 2 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices. The spare parts listed in this section are parts and components as defined in paragraph 1 of Article 23 of the same Regulation.
The definitions in Article 2 of the same Regulation apply to the manufacturers, importers and distributors listed in this section.