MDCG 2023-5 and MDCG 2023-6: two for the price of one - Products without an Intended Medical Purpose under Annex XVI
Medical devices regulation
🇪🇺 New MDCG Guides for Products Without an Intended Medical Purpose (Annex XVI of MDR2017/745) - Special offer : buy 2, save 1 💸
Medical Device Coordination Group (MDCG) has published two new documents regarding Product Without an Intended Medical Purpose (Annex XVI of MDR 2017/745).
1️⃣” MDCG 2023-5 Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies”.
This guidance document provides elements useful for the qualification of a product as a product without an intended medical purpose listed in Annex XVI to the MDR 2017/745 and (EU) 2022/2346. It also provides explanations and examples for the application of certain classification rules to products without an intended medical purpose, hereinafter also referred to as devices. The examples provided do not imply that the products are a priori qualified as devices. Classification rules apply after the qualification of the product as a device has been established.
This guidance document should be used in conjunction with the MDCG 2021-24 on classification of medical devices and take into consideration Commission Implementing Regulation (EU) 2022/2347 on reclassification.
There are interesting sections about “dual-purpose devices” and “multiple intended purposes” products, and examples of products that do not qualify as Annex XVI products. Classification and examples are sorted per group as per the CS. In my opinion, it is quite well done.
2️⃣” MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies”.
This MDCG guidance covers the demonstration of equivalence, based on data pertaining to an already existing device, for the purpose of CE-marking under the MDR and is applicable to products without an intended medical purpose listed in the Annex XVI of MDR and covered by the CS. For dual-purpose devices, which are devices with a medical and a non-medical intended purpose, this guidance applies only to the non-medical intended purpose. This guidance document should be used in conjunction with MDCG 2020-5 on equivalence.
Links to the guides below. Enjoy 💕
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