Class I medical device manufacturers may benefit from the transitional period under the MDR
On December 17, a corrigendum to Medical Device Regulation (MDR) 745/2017 was approved by the European Parliament that allows certain devices classified in Class I under Directive 93/42/EEC to benefit from the transitional period provided by the MDR. Therefore, manufacturers can continue to place these devices on the market under the previous legislation until May 2024, and the devices can continue to be made available to patients until May 2025.
According to the original version of the MDR, Class I devices placed on the market under Directive 93/42/EEC had to comply with the provisions of the MDR by May 26, 2020. In particular, according to the MDR, transitional provisions—which allow certain devices to continue to be placed on the market under Directive 93/42/EEC after May 2020—only applied to a device that had been placed on the market under a certificate of conformity issued by a notified body. As Class I devices are placed on the market under manufacturer self-certification, the transitional provisions did not apply to them.
Following this corrigendum, Class I devices may benefit from the transitional period, too, but only if the device meets the following requirements:
- under the MDR, its conformity assessment procedures require involvement of a notified body, while that was not required under Directive 93/42/EEC (e.g., software);
- the declaration of conformity was drafted under Directive 93/42/EEC prior to May 26, 2020; and
- the device continues to comply with Directive 93/42/EEC and there are no significant changes in the design and intended purpose.
Therefore, thanks to this corrigendum, manufacturers of these Class I devices can continue to place them on the market for an additional four years. However, there are still aspects of these provisions that need to be clarified, such as the meaning of the phrase “significant changes in the design and intended purpose.”
