Module 18 - Drug Device Combinations and Other Technologies

Other Factors influencing classification

- Does the Device contain a medicinal substance? - Does the Device contain animal derived tissue? - Does the Device contain a human blood derivative? (AIMD, IVD only under UK MDR Regulation 3)

Classification rules : General medical devices (Part II): Regulation 7 and Annex IX

IVD (Part IV): Regulation 40 and Annex II AIMD (Part III): All the same class – Class III

17

17

Special Rules – Annex IX

These are classification rules covering specific products which give specific products a specific classification:

Rule 13 – Rule 14 – Rule 15 – Rule 16 – Rule 17 – Rule 18 –

devices containing Medicinal Products

devices for contraception or prevention of STDs

devices for disinfecting

devices intended for recording X-ray images

devices containing animal tissues

blood bags

18

18

9