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May 19, 2024

What Is a Legacy Device?

If you’ve ever had to work with old computers, equipment or systems, you have probably come across the term “legacy device.” These devices are obsolete and often not compatible with newer technologies. They can slow down networks and cause a wide range of problems. This is why many companies have a hard time deciding whether to update or replace these devices. In some cases, it may make sense to keep them around for a while longer. This is why there are specific provisions for legacy devices within regulatory frameworks.

The medical devices industry is no exception. The new EU regulations on MDR and IVDR allow medical devices and in-vitro diagnostic devices that were CE-marked per the previous directives to remain on the market under certain conditions. The new regulations define what is considered a legacy device and how the term is to be used when applying for CE-marking under the MDR or IVDR.

There are also specific rules for changing legacy devices under the MDR and IVDR. If a medical device is changed in a way that affects its safety or performance, it must undergo a substantial change assessment (SCE). A manufacturer can only submit a SCE for a legacy device if the manufacturer has already submitted a SCE for that device or if the manufacturer has been granted a transitional period.

In the case of the MDR and IVDR, such a transitional period is usually 18 months after the date of application of the respective regulation. In addition, the manufacturers of legacy devices are required to register them in the EUDAMED database. This includes submitting a follow-up or final vigilance report for the devices.

However, in the case of the IVDR, there are a few more requirements that must be met. For example, the manufacturers of IVDR legacy devices must comply with the new cybersecurity requirements. In addition, the manufacturer must appoint a Swiss Authorised Representative (Section What specifically needs to be considered for legacy devices in Switzerland? below) and endorse a new Economic Operator Role.

Another important rule for determining what is a legacy device when it comes to the MDR and IVDR is the so-called “short usability engineering process.” In this process, the manufacturer can avoid formative and summative evaluations and only have to describe the use specification in an extensive way. This is possible as long as the devices were placed on the market before the publication of IEC 62366-1:2015 and meet all the other criteria in section 4.2.2 of the document.

The MDR and IVDR also regulate what procedure packs and systems are considered to be legacy devices. A system or procedure pack is considered to be a legacy device if all its components are considered to be legacy devices and a Statement per MDD Article 12 has been drawn up for them prior to 26 May 2021. In such a case, the entire system or procedure pack retains its legacy status until all of its components are changed to the latest version.