Products in the medical industry that were made before applicable standards or regulations came into effect are known as legacy products or grandfathered products. Since these products pre-date specific directives, they are often exempt from meeting the new regulations and are still allowed to be produced and marketed.
However, with the EU MDR changes coming in May 2021, device manufacturers need to take a look at how legacy products will be handled going forward since the new regulations will put the same level of scrutiny on both new and old products on the market.
What Challenges Exist For Legacy Products?
Medical device regulations are continually improving. Ongoing changes are made to further the realm of medical science, protect patients, and enhance the level of care available. The latest iteration of EU MDR focuses heavily on human factors, risk management, and post-market surveillance. Additionally, new rules dictate that devices not only need to comply with regulatory standards but also technical standards that are in constant review.
These ever-tightening standards and regulations present a challenge for legacy products since previously, once devices were approved for market, they did not need the same level of review or follow up. Legacy products would often stay on the market long after best practices evolved, and the product was no longer considered state of the art.
What EU MDR Says About Legacy Products
The new European Medical Device Regulations state that any products on the market will now need to be kept up to date with changes in standards and best practices. Essentially, legacy products will now need a level of review and follow up that was not previously required.
Will Legacy Products Get Reclassified?
Currently, medical devices are classified on a scale from Class I to Class III. With the new directive, it’s expected that a small number of devices will get reclassified, which will result in more research, evidence, and resources needed to prove EU MDR compliance. Although there are not a significant number of products up for reclassification, there is a chance that some legacy products—specifically products such as orthopedic implants, inhalers, and other active therapeutic devices—are going to be affected.
Devices that move up in class will be subject to more scrutiny from notified bodies, which is another risk that device manufacturers must take into consideration if they choose to keep their legacy product on the market.
MDR: Catalyst for Retiring Legacy Products?
In the past, legacy products were mostly grandfathered into new directives with little to no effort, so it made sense to leave them as-is on the market. Numerous legacy products are still widely accepted, giving the healthcare system more options for care. However, in some cases, the cost of making sure these legacy products comply with new standards is just not worth it in the end. In these cases, the new upcoming MDR directive will give manufacturers an opening to retire these types of products.
There are two things that manufacturers should consider before retiring their legacy products:
- Whether or not they have similar or better products that would be worth the investment to bring to compliance instead.
- How removing the legacy product from the market will impact healthcare providers and patients.
Why Not Retire All Legacy Products?
Legacy medical devices still have a role to play in the healthcare industry, even as medical device regulations become more strict. Although some new devices might be more advanced, legacy products themselves are still valuable. Here are a few reasons why we need a pragmatic approach to retiring legacy products:
- It might not be practical to remove the product from the market, as surgeons and other healthcare providers are trained in how to use the legacy product over a new product, in most cases.
- Integrating new devices takes time, and the legacy device is usually a good option for the “in-between” period when the new device is still not in wide use.
- In markets where the payer has control over procurement, it’s advisable to have lower-priced options available. Payers will not appreciate having to pay more for newer options when there is a less expensive, older option available.
- Even if the manufacturer decides to retire a legacy product, they still need to maintain compliance as long as patients are still using it. In the past, it was easier for legacy products to exist under new directives. However, the new MDR directives might cause notified bodies to review annual updates more strictly, thus requiring more effort from the manufacturer to ensure compliance.
In the end, it’s up to the manufacturer to decide whether or not they will invest the time, resources, and money to bring their legacy products to EU MDR compliance, however, it’s a decision that needs to be made soon. The deadline is just months away and legacy products will no longer be able to fly under the regulatory radar.
With the EU MDR deadline coming up next year, fast and efficient literature reviews are a necessity for all medical device manufacturers with products in the EU. Literature review software is the best way to optimize your process.