Get In Vitro Diagnostic Medical Device Regulations 13 & 14 ...

Classification of IVD medical devices The higher the potential risk an incorrect result would pose, the higher the classification. The higher the risk class of a device, the higher the level of assessment and monitoring is required to demonstrate initial and ongoing compliance with the conformity assessment procedures.

Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate to high risk that requires special controls. Class III: A medical device with high risk that requires premarket approval.

The IVDR establishes four risk classes based on both patient and public health risk: Class A - Low patient and public health risk. Class B - Moderate patient risk and/or low public health risk. Class C - High patient risk and/or moderate public health risk.

Class I includes devices with the lowest risk and Class III includes those with the greatest risk. As indicated above all classes of devices as subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.

The classification rules are based on a risk based approach to regulation, and IVDs are classified ing to the health risk (either to the public or an individual) that may arise from an incorrect result. The higher the potential risk an incorrect result would pose, the higher the classification.

Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.

In March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the removal of the sell-off period to prevent unnecessary disposal of safe in vitro diagnostic medical devices that are still in the supply chain.