▶ Introduction
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical purpose that are listed in Annex XVI as from the date of application of the Commission Implementing Regulation (EU) 2022/2346, hereinafter referred to as the common specifications (CS).
Products without an intended medical purpose that are listed in the Annex XVI to MDR and that are included in the scope sections of the CS’ annexes are covered also by the MDR. Qualification of a product without an intended medial purpose precedes its classification. Only products that qualify as devices and that are covered by the CS and the MDR should then be classified according to the rules set out in Annex VIII to MDR and in Commission Implementing Regulation (EU) 2022/2347 on reclassification.
Classification rules set out in Annex VIII to MDR apply to those products. Also Commission Implementing Regulation (EU) 2022/2347 applies for classification purposes of certain active devices without an intended medical purpose. The document MDCG 2021-24 on “Guidance on classification of medical devices” should be read together with the present guidance document, except for the elements which are specific to devices with a medical purpose.
MDCG 2023-5 - Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies
MDCG 2023-5 - Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies - December 2023
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