Implantable devices & implant card
MDR Art. 2(5) (definition); MDR Annex VIII Rule 8 (classification); MDR Art. 18 and Annex XV §2.12 (implant card); MDR Annex I §22–23 (GSPR for implantables). Active implantable devices are governed by the same regulation (AIMDs are now Class III under MDR).