What is a legacy device in the EU MDR (Medical Device Regulation)?

When the Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Regulation (EU 2017/746) came into force, they changed how medical devices undergo conformity assessment and are maintained. But what happens to devices that were already introduced to the market under previous directives? Let’s get into the legacy device in the EU MDR meaning.

Legacy devices under MDR/IVDR – TL;DR

Legacy devices are medical devices that successfully passed conformity assessment (approval process) under the old European Union Directives that continue to be placed on the market during the MDR/IVDR transitional periods. 

They remain on the market under special rules but still have to meet Medical Device Regulation (MDR) requirements in set time. Some examples of legacy devices include autoclave certified under Medical Device Directive which now must adapt its documentation and Post–Market Surveillance (PMS) process to meet MDR standards.

What is a legacy device?

In general, the term “legacy” refers to the products compliant with an earlier standard, act, regulation, etc. and are still offered, but only to some extent.  This term can be used in different settings, including medical devices.

What is the definition of legacy devices in the EU MDR?

So, what does legacy device mean? In short, a legacy device in the EU MDR is a product that:

• was legally placed on the market under the Medical Device Directive, Active Implantable Medical Devices Directive, or In-Vitro Device Directive,

• remain available after MDR/IVDR came into force,

• continue to be marketed under transitional provisions or conditional compliance with new regulations.

Whereas, European Commission defines legacy medical devices as “medical devices, active implantable medical devices and in vitro diagnostic medical devices that are covered by a valid certificate issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and that continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR)”.

What are examples of legacy devices in the EU MDR?

Let’s look at a few examples of legacy devices to understand what is considered a legacy device.

One example is a medical software that analyses electrocardiogram (ECG) data to support diagnosis. It was certified under Medical Device Directive (MDD) as a Class IIa device, but now, under the MDR’s new classification rules, it can be up-classified to Class IIb.

Another is an autoclave with embedded firmware, which was certified under MDD. The manufacturer maintains and updates the product, including preparing documentation to comply with IEC 62304.

A third example is a patient monitoring system that, although previously certified under MDD, now requires implementing a Post-Market Surveillance system to monitor its performance and ensure ongoing safety actively.

What is not a legacy medical device?

Several types of devices cannot be considered legacy devices. They include:

• devices placed on the market after the date of MDR (26 May 2021) or IVDR (26 May 2022) application,

• Class I devices which were required to obtain CE marking under the MDR/IVDR by the date of application,

• devices with significant changes to the design, intended purpose, or software that alter the device’s performance.

What are the MDR requirements for legacy devices?

When the EU regulatory framework shifted from directives to regulations, the obligations for legal manufacturers in the European Union also changed. MDR and IVDR introduced a more transparent approach to developing devices.

There are many key updates, and among them you can find:

• verifying whether the device’s classification needs to be updated under MDR rules,

• implementing a Post-Market Surveillance (PMS) system that meets new requirements,

• ensuring compliance with vigilance,

• and more.

What should you do with your legacy medical device?

So, what does it mean for legal manufacturers? Manufacturers must assess transitional provisions and ensure MDR/IVDR compliance.

A good step would be a comprehensive gap analysis to assess documentation compliance for any missing steps and a code audit. At Revolve Healthcare (a custom medical software development company), we support you through reviewing classification, auditing processes, refactoring your code, and implementing necessary data privacy and cybersecurity controls.

Key takeaways

• Legacy devices are old MDD/IVDD-certified products still marketed.

• Manufacturers must verify the device’s classification per MDR rules.

• One of the obligations is to implement a Post-Market Surveillance (PMS) system.