Paul Brooks, Regulatory Affairs Professionals Society (RAPS), discusses the impact of European Medical Device Regulation on currently marketed medical devices and offers guidance for manufacturers.
MDR Regulation
From 2020, all new medical device products in Europe must fully comply with the European Medical Device Regulation (MDR). While currently, medical device manufacturers must meet the requirements of the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD), the new regulation will include changes to the classification of some medical devices. In addition, more prescriptive guidance on the content of technical documentation, and in some cases greater amounts of clinical data, will be required.
As we begin the three-year countdown to the changes, the big question on many manufacturers’ minds is what will the MDR mean for currently marketed products in Europe? How many hurdles will medical device manufacturers need to overcome to ensure compliance? And will the new regulations lead to some products no longer entering the market?
The value of early adoption
In Q2 2017, the European MDR will enter into force, with a three-year transition period. During the transition, manufacturers can choose to comply with the MDD or the AIMDD but any certificates issued under these directives will expire four years after the 2020 full application of the MDR.
While this gives manufacturers of currently marketed products some breathing space, there are a number of reasons why early adoption of the new requirements could be preferable. For example, the market may become sensitive to the fact that there is a new regulation and some products are not complying with it, giving competitive products that do comply with the MDR an advantage. In addition, simultaneously managing product ranges under both the MDD and MDR requirements may prove too complex and time consuming for some manufacturers.
Three key considerations for legacy products
Will my products be reclassified?
Under the existing directives, all medical devices are classified from class I to class III (with the latter indicating the higher risk products). The vast majority of medical devices will not be reclassified under the new regulation but for those that are, the impact could be significant. For example, products that are up-classified to class III will require a more significant notified body review and will be subject to greater scrutiny in terms of the clinical data that is available. In fact, the latter is also true for implantable devices that do not change classification.
There is no short-cut to understanding the impact of reclassification on your products. While in the US, the authorities outline a list of products and clearly state the classification, the European approach is to publish a set of rules and it is then the manufacturers responsibility to review them and define the impact on their products. This process becomes even more complex when you consider that some products may be classified under multiple rules, in which case they must comply with the highest classification stated.
Is now the time to rationalise my product range?
In any business, return on investment (ROI) must be a factor when considering any major changes to products. For low turnover, legacy products, the cost of compliance may simply not be justified. Manufacturers may use the introduction of the MDR as an opportunity to remove poor performers from the market. Before doing so, they must consider whether they have more modern versions or better performing products that can comply. This is likely as many devices have evolved over time to incorporate new designs and upgrades in line with postmarket surveillance data—for many devices it is unusual for designs to remain static over a long period. However, it’s important to remember that there are some extremely valuable legacy products with strong market acceptance that help to bring choice to clinicians and healthcare systems. It is more likely that some ‘me too’ products could be eliminated as medical device manufacturers look to rationalise their offerings.
What will be the impact on my customers?
In the worst-case scenario, manufacturers that do not comply with the MDR will no longer be able to supply their products. In the event that older, and potentially lower cost, legacy products could no longer be available going forward, this could also have an impact on costs for hospitals and healthcare providers. It’s important to not only consider the implications for your product range, but also the potential effects on the customer and ultimately the patient.
Final thought
There are a number of factors to consider when preparing currently marketed products for the MDR requirements, which may see the rationalisation of product ranges and the reclassification of products. There is a strong argument to standardise on the MDR requirements as early as possible during the three-year transition period, applying them to both new and legacy products to generate efficiencies.