Annex XVI Devices Without an Intended Medical Purpose – Current State of Play
Annex XVI devices are devices without a medical intended purpose that are within the scope of the MDR. In the past two years, there have been a number of regulations, common specifications and guidance documents that have been published regarding these devices. This article is intended to explain the current state of play of these ...
Q&A Published on Transitional Provisions for Products Without an Intended Medical Purpose Covered by Annex XVI of the MDR
On June 21, 2023, the Official Journal of the European Union published the Implementing Regulation (EU) 2023/1194 amending the transitional provisions laid down in Implementing Regulation (EU) 2022/2346 for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (MDR). This document has been adopted to align the transitional provisions ...
