EUROPEAN UNION: Interpretative guide for “significant changes” under Art. 120 of MDR (EU) 2017/745

To help manufacturers determine whether the change to the purpose (destination) or the design of their device is a “significant change”, as referred to in Art. 120 (3) of Regulation (EU) 2017/745, GMED (French Notified Body, CE 0459) has published a guide.

EUROPEAN UNION: Interpretative guide for “significant changes” under
Art. 120 of MDR (EU) 2017/745

Art. 120 of MDR (EU) 2017/745 provides transitional arrangements including the possibility to maintain until May 27, 2024 – if certain conditions are met – the validity of the certificates of conformity to Directives 93/42/EEC and 90/385/EEC valid on May 26, 2020.

Based on the NBOG’s Best Practice Guide, “Guidance for Manufacturers and Notified Bodies on Reporting Design Changes and Changes in Quality System” (NBOG BPG 2014-3), it provides five useful flowcharts that help manufactures decide whether the changes made to their medical device are considered significant changes or not.

More specifically, the diagrams refer to the following types of changes:

  • Changes to the purpose/destination of a medical device;
  • Changes to the design of the medical device
  • Changes to the design: components or materials;
  • Changes to the design: method of sterilization or conditioning necessary to preserve the sterile condition
  • Changes to the design: software changes

The guide goes into detail and describes each type of aforementioned change.

As of May 26, 2020, any significant change in the design and purpose (destination) of a device covered by a certificate of compliance with the Directives (ref. Directive 93/42/CEE and 90/385/CEE) will result in the invalidity of the existing certificate. This provision concerns all classes of medical devices.

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