Grace period for up-classified Class I medical devices receives green light at European Parliament


The EU Parliament has confirmed the approval of a corrigendum to the EU Medical Devices Regulation[1] (EU MDR) that has the effect of providing a four-year ‘grace period’ for manufacturers of class I medical devices which are up-classified by the EU MDR (requiring assessment by a notified body for the first time under the EU MDR).

The corrigendum allows affected devices to continue to be placed on the market or put into service for the first time after 26 May 2020 (when the EU MDR comes into force) until 26 May 2024. Also, once placed on the market, such devices can continue to be made available or put into service subsequently until 26 May 2025. More details concerning the wording and impact of the corrigendum may be found in our previous article on the subject, Good news for manufacturers of up-classified Class I medical devices.

The text of the corrigendum had been approved by the Environment, Public Health and Food Safety Committee of the European Parliament on 3 December 2019.  Following the procedure established for the approval of corrigenda, that text was announced at the part-session of the plenary of the European Parliament on Monday, 16 December 2019. This opened a period of 24 hours for any parliamentary group or group of MEPs to submit a request that the corrigendum be put to a vote at the plenary. Yesterday, the European Parliament announced that no such request had been received within that time limit, and thus the corrigendum was deemed formally approved by the European Parliament.

The next step for the corrigendum to come into force will be its publication in the Official Journal of the EU, which is likely to take place well in advance of the entry into force of the EU MDR next May 2020.

[1] 2017/745