Guidance on significant change for legacy devices (MDR)

All manufacturers making use of the grace period as per the Article 120 (3) of the MDR – with a CE Certificate issued under the MDD/AIMDD – shall carefully read the most recent guidance published by the MDCG.

This is probably one of the most awaited documents as it lays downs what the MDCG considers a “significant change in design or intended purpose” of a device; and in which cases can therefore a manufacturer of legacy devices use the benefit of Article 120(3), i.e. placing a compliant device with a valid MDD Certificate on the market after the MDR date of application, i.e. 26 May 2020.

When it comes to validity of a CE Certificate (issued in accordance with MDD/AIMDD) after May 2020, it should be added that manufacturer shall communicate all changes to the Notified Body for evaluation.

Class I medical devices manufacturer, who will newly require the involvement of a Notified Body under the MDR (e.g. reusable surgical instruments), must be able to justify their decision when the changes are considered to be non-significant. The justification shall be documented and made available when requested.

Please do not forget that certain requirements of the MDR apply as of 26 May 2020 also for legacy devices:

  • Post-market surveillance
  • Vigilance
  • Market surveillance
  • Registration of economic operators (EUDAMED will be operational by May 2020) and devices
  • PRRC, AR under MDR, obligations of distributors,…

You can find the full text of the MDCG Guidance in our dedicated Library – MDR- MDCG.

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