2021.05.17

Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

From May 2022, the In Vitro Directive 98/79/EC will be repealed with the new In Vitro Medical Device Regulation (IVDR (EU) 2017/746). In accordance with this Regulation (EU) 2017/746, devices will change the classification rules and shall be classified into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks (Article 47).

mdcg_2021-4_en.pdf

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Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

The classification of a device is defined by its intended purpose, as specified by the manufacturer in the technical documentation of the device. Where there is a foreseeable risk that a device may be used for purposes which are covered by other classification rules and which would result in classification of a device into a higher class, a clear limitation of use should be included in the technical documentation (Labels, IFU…).

md_mdcg_2020_guidance_classification_ivd-md_en.pdf