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).
The transitional provisions for products listed in Annex XVI for which a notified body has to be involved in the conformity assessment procedure are extended until December 31, 2028 or December 31, 2029, depending if a clinical investigation is performed or not and under certain conditions.
Where products were covered by a certificate issued by a Notified Body in accordance with Directive 93/42/EEC, valid after May 26, 2021 and that has not been withdrawn, they may continue to be placed on the market in accordance with the transitional provisions defined in Article 120 of MDR, under conditions, even if the written agreement (contract) has not been signed between the manufacturer and the Notified Body before the said certificate expires, or if no Competent Authority has issued a Derogation under Article 59 or a communication under Article 97 of the MDR.
As a reminder, Implementing Regulation (EU) 2022/2346, amended by Implementing Regulation (EU) 2023/1194, laying down common specifications for the groups of products without an intended medical purpose came into application on June 22, 2023, making MDR applicable to them.
DOWNLOAD THE IMPLEMENTING REGULATION (EU) 2023/1194
share
Events
Find an answer to the challenges you are facing in one of our upcoming events: trainings, webinars, forums...