EU: The Amendment of Extension of Transitional Period Regulations

ARQon
Apr 10, 2023
1 min read

Updated: Apr 13, 2023

On June 2022, a cabinet of ministers voiced concern about the implementation challenges that may trigger the delay or discontinuity of medical devices in the market. Market flow has indicated that manufacturers or importers may not be able to keep up with the medical devices regulation (MDR). As the topic at the top of the urgent list, the European Commission has lined out a draft plan to prevent any shortage of medical devices in the market.

Three main proposed actions are the staggered transitional period for both high-risk devices and low-risk devices, certificate validity extensions and cancellation “sell-off” deadline for the products to be in the market. For further information, can refer to our previous article regarding the proposed amendment.

Therefore, the European Commission revised the proposal and released the amended regulations on 15 March 2023 under Regulation (EU) 2023/607. The Regulation was approved to secure public health and patient safety and ensure no medical device shortage.

The extension of the transitional period only applies to devices that have fulfilled the condition of MDR’s transitional provisions, for instance, Class I devices under Directive 93/42/EEC (MDD) and devices with EC certificate under Directive 90/385/EEC. Meanwhile, for the “sell-off” date cancellation, the benefitted devices are the medical devices that has been placed on market before 26 May 2021 with MDD/AIMDD compliance or after, during the transitional period and the in vitro diagnostic medical devices on market before 26 May 2022, also must comply with IVDD or after, during the transitional period.

Source: European Commision