February 24, 2023

What Changes are Allowed for EU MDR Article 120 Legacy Devices?

In general, from purely a legislative EU MDR / MDD perspective, if an EU MDR Article 120(2/3) MDD-certified transitional device has, “…no significant changes in the design and intended purpose…”, then it can be placed on the market or put into service under the MDD certificate until the EU MDR Article 120’s corresponding sunset deadlines.  This means that changes are in fact allowed to be made to the Article 120 transitional device, and that the changed device can in fact be placed on the market, as long the change and the composite of multiple changes made since MDD certification, doesn’t exceed the Article 120 limits (no significant change in the design or intended purpose).

However, sometimes your contract with your Notified Body (NB) might deviate with the pure legislative intentions of Article 120.  So be sure to check your NB contract to see what obligations it demands.  If that contract requires formal NB notification and/or approval of changes that don’t align with the Article 120 provisions, then you would be legally bound by that contract and would thus need to lobby the NB for a contract revision or concession.