MDCG 2022-6: Making Changes to Legacy Devices Without Triggering EU IVDR Compliance

In May 2022, the Medical Device Coordination Group (MDCG) issued MDCG 2022-6, which outlines allowable changes under the IVDR to manufacturers holding valid IVDD device certificates. This guidance document clarifies Article 110(3) of the IVDR, which is reproduced below:

Below are some of the changes that could invalidate your IVDD certificate and require you to comply with the full requirements of the IVDR instead. You are strongly advised to consult with your Notified Body to ensure that there is an alignment on the potential impact of any applicable proposed changes.

Pages 12-17 of MDCG 2022-6 include numerous flowcharts to help you make decisions about whether a change is significant or not. Examples of some significant changes include:

• Changes to, or extension of, the intended purpose (see section 4.3.2.2 and Chart A)
• Changes to the design, software, ingredients, materials, or sterilization of the device (see section 4.3.2.3 and Charts B, C, D, and E)
• New or major changes to the software operating system, architecture, database structure, or algorithm
• Changes to manufacturer name, address, manufacturing sites, etc.
• Change of supplier, if no changes to specifications of materials, ingredients, or components are impacted (see Chart D)
• Changes to authorized representative or importer
• Changes to outer packaging that do not affect sterility, stability, or microbiology of device
• New process validations
• New surveillance or vigilance procedures in compliance with the IVDR
• Registration of devices and Economic Operators in compliance with the IVDR
• Changes to the quality management system (QMS)
• Changes to corrective actions accepted by the competent authority
• Software bug fixes, third-party software updates, cybersecurity patches, and UI enhancements that do not impact performance

Trust the Guidance but Get Your Notified Body to Verify

Leave Plenty of Time to Get Your IVDR Certificate

Since demands for Notified Body services at an all-time high, maintain contact with yours early and often to ensure you are scheduled for your audit well in advance of the expiration of your certificate or May 26, 2025, whichever comes first. You will need the time to gather the necessary clinical evidence to support your IVDR submission and everything else that comes with IVDR compliance. If you are an internal auditor and need to make sure you are ready for your audit, consider our intensive IVDR auditor training course. Contact Oriel STAT A MATRIX for assistance in developing a transition quality plan to ensure your IVDD devices can legally remain on the market during the short transition period.