Q&A on Annex XVI transitional period

In June 2023, the Official Journal of the European Union published the common specifications for the new legacy period of Annex XVI devices. The Medical Devices Regulation (MDR) covers certain devices without an intended medical purpose, listed in Annex XVI.

In September 2023, the European Commission published “Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR“.

Main points addressed in Q&A on Annex XVI transitional period

The document addresses several aspects concerning the transitional period applicable to Annex XVI devices and defined in the common specifications from June 2023. Some of the main answers clarify the following:

• The common specifications apply to Annex XVI products from 22 June 2023.
• MDR applies to Annex XVI products from 22 June 2023. However, there is a transitional period.
• For Annex XVI products covered by a valid MDD certificate, the legacy period per Article 120 applies. The period ends on 31 December 2027 for higher-risk products and on 31 December 2028 for lower-risk products.
• The transitional period for products for which a notified body is involved in the conformity assessment and the manufacturer decides to carry out a clinical investigation starts on 22 June 2023 and ends on 31 December 2029.
• The transitional period for products for which a notified body is involved in the conformity assessment and the manufacturer does not intend to perform a clinical investigation starts on 22 June 2023 and ends on 31 December 2028.
• There are no specific transitional provisions for Annex XVI devices incorporating a medicinal product.
• The transitional provisions set out in Article 120 apply also to dual-purpose devices.
• Manufacturers demonstrate that their product benefits from the transitional period with a self-declaration.
• There is no deadline to make available products placed on the market during the transitional period.
• Notified bodies can issue certificates for Annex XVI products under the MDR during the transitional periods.

Manufacturers of legacy devices are eligible for the new transitional period when meeting certain requirements.

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