EU Medical Devices Regulation (MDR 2017/745) MDR-Art.1_2_3_4: Subject matter, scope, definitions and regulatory status (Articles 1-4)

Article 1 establishes the scope: medical devices for human use and accessories. Sectoral carve-outs include in vitro diagnostics (covered by IVDR), medicinal products (Directive 2001/83/EC), human blood, transplants, foodstuffs. Article 1(2) makes specific provisions for devices incorporating a medicinal-product substance or human-blood derivative. Article 2 supplies definitions including 'medical device', 'accessory', 'active implantable medical device', 'custom-made device', 'investigational device', 'single-use device', 'reprocessed device', 'Class I/IIa/IIb/III', 'PRRC', 'EUDAMED', 'UDI', 'serious incident', 'field safety corrective action (FSCA)', 'periodic safety update report (PSUR)'. Article 3 governs regulatory-status determinations. Article 4 covers products with both medical and non-medical use.