It’s been a year—have you adjusted to the EU MDR Guidance on “Significant Change” and Clinical Evidence for Software?

EU flag in front of European Parliament Building in Brussels, Belgium

The EU Medical Device Regulations (MDR) were applied on March 21, 2020. Of course, it was under highly unusual circumstances: the COVID-19 global health crisis. This put additional strain on the already overburdened MedTech industry, and tensions around the revision of the Swiss-EU mutual recognition agreement were adding to the pressure. However, some positive news for the industry is the Medical Device Coordination Group’s (MDCG) release of much-needed guidance on a number of key topics that will assist the industry in its efforts to comply with the MDR, as well as the EU In Vitro Diagnostic Medical Devices Regulation (IVDR).

Here we focus on Class II and Class III devices.

1. What determines a “significant change” in the design and intended purpose of a medical device?

The interpretation of a “significant change” is key for devices that benefit from the provisions set forth in Article 120(3) of the MDR. Devices with valid CE certificates issued prior to May 26, 2020 under the EU Medical Devices Directive (MDD) or the EU Active Implantable Medical Devices Directive (AIMDD) will no longer benefit from these provisions if they undergo a “significant change.”

Flowcharts are included and largely based on the Notified Body Operations Group’s (NBOG) previous guidance. These flowcharts provide a roadmap of the various assessment steps that can be taken to reach the result and by what criteria a change should be deemed “significant” or not. A specific flowchart is provided for each of the following:

  • Changes in intended purpose, noting that changes other than a limitation of the intended purpose will nearly always be considered “significant”
  • Changes in the design or performance of the specification, noting that certain changes in the design related to corrective actions may be deemed “not significant”
  • Software changes, as further detailed below
  • Changes of a material
  • Changes of terminal sterilization method of the device or changes to the packaging design affecting the sterilization

A few of the software changes that will usually not be considered “significant” include: correction of an error that does not pose a safety risk (e.g., bug fixes); security updates (e.g., cybersecurity enhancements); appearance of the user interface; operating efficiencies; and enhancement of the user interface without influencing the performance.

The bottom line is that manufacturers must bring any change in the design or intended purpose of their medical devices to their notified body, so an assessment can be conducted to deem whether such change is “significant.” This will be decided on a case-by-case basis. The NBOG can then also confirm, in writing, that a change does not qualify as “significant,” as it pertains to Article 120(3) of the MDR.

2. What kind and how much clinical evidence do manufacturers of medical devices need to justify conformity of MDSW (Medical Device Software)?

This guidance for MedTech companies collecting clinical evidence for their medical device software adheres to the following principles:

  • Manufacturers must verify that the information generated by the MDSW focused on the targeted condition indicated in the relevant device’s intended purpose. This can be documented by literature searches, professional guidelines, proof of concept studies or by studies conducted by the manufacturer and its affiliates.
  • Manufacturers must verify that the MDSW accurately, consistently and—most importantly—reliably, meets the intended purpose. This is done via real-world usage testing through Independent Validation & Verification (IV&V). The areas of focus are: unit-level, integration and system testing. This must be done independently and in conjunction with previously collected patient data so that true objective evidence can be documented.

Manufacturers must document that the MDSW has been tested for the intended use, target population, use conditions, operating and use environments, with all intended user groups, and all objective evidence must be provided.


If you have any questions about the EU MDR guidance or require any other assistance with your project, contact our Product Development & Software Services team by submitting a contact form or e-mail ssmail18@generaldigital.com.

© symbiot / Shutterstock
© symbiot / Shutterstock

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