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EU MDR delays for class I medical devices

Further delays for class I medical devices have been announced following the Council of the European Union’s second corrigendum.

EU Medical Device Regulation (EU MDR) is planned to come into effect on 26th May 2020. However, MPN previously reported on the possibility of potential delays to EU MDR for class I medical devices.

Following the Council of the European Union’s second corrigendum, additional time will reportedly be given to comply with new legislation for both the makers of reusable class I medical devices, as well as the makers of class I software which is set to be up classified under EU MDR.

An extra four years will be awarded to three types of class I medical devices. These include devices which fully comply with the Medical Device Directive (MDD) and are either:

  1. Reusable surgical instruments
  2. In sterile conditions
  3. Have a measuring function and may remain or be placed on the market until 26th May 2024

This news is likely to be welcomed by relevant manufacturers who will now have more time to prepare the necessary documentation for their devices.

Why is there a delay?

A possible reason for this delay could be the large number of devices such as scalpels and forceps which need to undergo notified body review for the first time under EU MDR.

Additionally, although some devices were granted a ‘grace period’, this was typically awarded to higher risk devices. This 'grace period' meant certain organisations had already been given an additional four years to seek recertification.

Is this a done deal?

It is important to note that these changes for class I devices still need to be formally adopted by the European Parliament.

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