Home page > News > Last News > The new transitional deadlines for medical devices
REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
New transitional deadlines for Medical Devices under the Medical Devices Regulation (MDR) :
Higher risk class III and class IIb devices to 2027 instead of May 2024 at the latest. Class 1 devices (which need a NB certificate under MDR) to 2028 instead of 2025 Class IIa devices to 2028 instead of May 2024 at the latest.
Removal of the “sell off” date of May 2025 under both MDR and the In Vitro Diagnostic Devices Regulation (IVDR).
2023-07- EU Commission Q&A Transitional Period REV. 1 JULY 2023(PDF – 482.1 kb)2023-07- EU Commission Q&A Transitional Period REV. 1 JULY 2023
2023-03-20 REGULATION (EU) 2023_607 Transitional provisions(PDF – 2.6 Mb)2023-03-20 REGULATION (EU) 2023_607 Transitional provisions MDR IVDR
© 2024 - [MediMark® Europe]. All rights reserved
