Module 18 - Drug Device Combinations and Other Technologies

Risk Classes

• The UK MDR classifies all medical devices as per the level of risk associated with their use.

• There are 4 (or 4.5?) classes of medical devices, sorted I to III in order of increasing risk: Class I and I(m), I(s) , – low risk Class IIa and Class IIb – medium risk Class III –high risk • Which class a device fits into is determined by the rules laid out in Annex IX. – Part II of the Medical Devices Regulations 2002, Annex IX [as modified by Part II of Schedule 2A to the Medical Devices Regulations 2002]

13

13

Risk Classification - IVDs

• There are 4 main groups of IVD medical devices: “General” IVDs – considered low risk IVDs for self-testing – medium risk

Annex II, List B –high risk Annex II, List A –high risk

• Which class a device fits into is determined by the intended purpose and whether it is listed in Annex II.

• Note: EU IVDR Annex VIII sets out classification rules for IVDRs in EU (and Northern Ireland), and IVDs are classified differently (class A, B, C or D) under EU MDR. Classification rules under IVDR are set out in MDCG 2020-16 – latest version rev. 2

14

14

7