ELM-325-02

Member State Penalties

Penalties

The Member States will lay down rules and penalties in regard to any infringement or non-compliance to the items contained with EU MDR 2017/745.

They will take measures to ensure full compliance is delivered.

The penalties will be: –

  • Effective;
  • Proportionate; and
  • Dissuasive.

The Member States will inform the EU Commission of such rule by 25th February 2020 (possibly subject to delay due to Covid-19).

Subsequent amendments will also need to be notified as they arise.

Author

Ian Nicholls

Director at Explic8