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Regulation (eu) 2017/745 on mds: application almost postponed to may 2021

On April 3rd, 2020 the European Commission published a Regulation in which a one-year delay is proposed to the Regulation (EU) 2017/745 on Medical Devices (MDs). The European Parliament approved the adoption of the new Regulation on April 17th, 2020 and the Date of Application of the Regulation (EU) 2017/745, previously set for May 26th, 2020, moved to May 26th, 2021. However, the new Regulation must now also be approved by the Member States and be published in the Official Journal of the European Union, in its final approved form, for the delay to be legally binding and to take effect.

The primary driver for the delay approved by the European Union is the current COVID-19 pandemic, which has a huge and unprecedented impact on the Member States, who must guarantee the availability of medical devices and other products necessary in order to defeat this disease as primary target. Nowadays, the Member States and their health institutions are not in a position to ensure the actions needed for the proper implementation and application of the Regulation (EU) 2017/745.

The delay of the Date of Application of the Regulation (EU) 2017/745 gives the possibility to carry out the following activities until May 26th, 2021:

  • all the medical devices can be placed on the market under the Directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD).
  • new MDD and AIMDD certificates can be issued;
  • existing MDD and AIMDD certificates can be renewed.
  • starting a new clinical study under the current Directives;
  • serious adverse events are still reported under the current Directives.

In practice, the modification of the Regulation (EU) 2017/745 can be summarized as a change of the data, (every “2020” present in the Regulation itself has been substituted). No modification involved the activities with other timelines, subsequent to 2020, such as:

  • the so-called “grace period”, the period during which devices may still rely on valid certificates issued under the current Directives, which still ends on May 26th, 2024;
  • the dates by which the UDI must be on the label, which varies depending on the class of the device itself.

Moreover, no delay has been adopted for the Regulation (EU) 2017/746 on in vitro diagnostic medical devices, which will be applied on May 26th, 2022.

Written by: Daniele Scarpino