Implementing Regulation (EU) 2023/1194 on transitional provisions for Annex XVI products adopted
10 July 2023
On 20 June 2023, the European Commission introduced Implementing Regulation (EU) 2023/1194 amending Implementing Regulation (EU) 2022/2346 and stipulating the transitional provisions for certain products without an intended medical purpose as listed in Annex XVI to Regulation (EU) 2017/745.
Effective from 22 June 2023, the new regulation allows for the application of common MDR specifications to the Annex XVI devices with a certificate issued by the notified body and in accordance with Directive 93/42/EEC (MDD). Further to this, the regulation obliges the stakeholders to minimise the overlapping of conformity assessment procedures for products without an intended medical purpose and medical devices in order to reduce the risk of capacity shortages at notified bodies and avoid supply chain disruptions of medical devices.