New Q&A Document on Transitional Provisions for Products Without an Intended Medical Purpose Covered by Annex XVI of the MDR

The European Commission has released a new Q&A document to provide guidance on the application of the transitional provisions in the Medical Device Regulation (MDR) for products without an intended medical purpose covered by Annex XVI.

The document covers a range of topics, including the definition of these products, the different transitional provisions that apply, the conditions that must be met to benefit from them, and the deadlines for the transitional periods.

Some key takeaways from the document are that products covered by the transitional provisions must be placed on the market before May 26, 2024, must be in accordance with the Medical Device Directive (MDD), and must not be subject to a corrective action or field safety corrective action.

Manufacturers of these products should carefully review the Q&A document to ensure that they understand the requirements and are in compliance with the transitional provisions.

🔗 Original Document:  https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf