As regulatory data stewards prepare medical device product datasets for EUDAMED UDI submissions, there are several scenarios to consider. A quick assessment of the requirements and your particular business portfolio strategies will likely create new questions concerning what to do next.
If you are familiar with the medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), you will soon discover that the portfolio could fall into three different categories:
- Directive devices that are currently being marketed under the (MDD/AIMDD/IVDD) and are discontinued as of the Date of Application (DoA, 26 May 2021). The first two directives are now past (MDD/AIMDD).
- Legacy devices, if they meet some criteria, are able to continue to be placed on the market for a period of time.
- MDR/IVDR compliant devices can be evaluated and certified by a notified body.
Now that the MDR Date of Application is past, the first two (MDD/AIMDD) come off the list, and you will have to discontinue those directive devices. For those that meet the criteria for the Legacy category, there is a lifespan of about three years.
A note about Class I devices, as they do not have a provision within the Legacy category is that they would already have to comply with MDR for self-certification.
For IVDR, the DoA occurs one year after MDR (26 May 2022) with a similar pattern as MDR on subsequent timing for Legacy and IVD.
EU Legacy Device definition?
Surprisingly, the phrase ‘legacy device’ is nowhere to be found in the regulations. Both of the regulations discuss the concept, but they don’t actually use the term ‘legacy device’. There are a number of *guidance documents that reference the concept and provide a definition.
The definition encompasses medical devices, active implantables and in vitro diagnostics that have a valid certificate issued according to one of those corresponding directives (MDD, AIMDD or IVDD). MDR Articles 120(3) and IVDR Article 110(3) provide more relevant criteria for a product to comply as a ‘legacy’ device. There are a number of published guidance statements to review for a complete understanding of this concept and scenarios.
For a detailed walk-through of EU Legacy Devices, register to view the short series of explanatory videos:
- Description and MDR/IVDR Timeline (view below)
- Criteria and the 6 Modules of EUDAMED
- Provisions – explanation of ‘equivalent’ device
- UDI/Device Registration and BUDI-DI, UDI-DI
- Compare Regulation and Legacy Devices
- Walk through a business ‘use case’ for a manufacturer
In this series of 6 videos, Gary Saner, Sr Mgr Information Solutions at Reed Tech, does a deep dive into ‘What to Know’ concerning EU Legacy Devices for both MDR/IVDR, description, provisions, requirements and timelines.
To view the video series, please fill out the form below.
Published guidance continues to develop for health authorities and can be quite nuanced from past learnings with the US FDA experience. Get in touch with Reed Tech to see how product data management can be handled with flexible team roles and data validation tools in a dedicated solution like Reed Tech SingleSource™ for Medical Devices.
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