By Paul Brooks, RAPS
As the 2020 deadline nears for the European Medical Device Regulation (MDR), there is growing concern among many manufacturers as to what the MDR will mean for currently marketed products in Europe. The new regulation will include changes to the classification of some medical devices, as well as more prescriptive guidance on the content of technical documentation, and, in some cases, more clinical data will be required than under the current directives.
The question for manufacturers is how many hurdles will they need to overcome to ensure compliance, and will the new regulations lead to some legacy products no longer entering the market?
The Value Of Early Adoption
The European MDR entered into force in May 2017, with a three-year transition period. During this time, manufacturers can choose to comply with the existing Medical Device Directive (MDD)/ Active Implantable Medical Device Directive (AIMDD) requirements, or the new MDR (subject to the availability of notified bodies designated to conduct MDR conformity assessments). However, certificates issued under the old directives will expire four years after the MDR comes into full force in May 2020.
Early adoption of the new requirements has several advantages. There is likely to be some market sensitivity to the new regulation and a preference for products that are proactively compliant. Some procurement agencies and regulators that recognise CE marking outside of Europe may become conditioned to expect CE certificates that meet the latest requirements. It’s also likely that managing product ranges under one requirement will be less complex and less time-consuming.
Challenges For Notified Bodies
There is currently a concern about the capacity of notified bodies (NBs) to complete all the necessary conformity assessments required for compliance with the MDR within the available time frame.
Many NBs have applied for designation under the MDR, but this process could take 12–18 months or more to complete, meaning that the ‘real’ transition window is significantly reduced. There also is the risk that NBs currently designated under the MDD may not achieve designation under the MDR, may decide to apply for a more restricted designation, or may not apply at all, further reducing NB capacity.
All three scenarios create the potential for significant backlogs toward the end of the transition period. Companies that wait too long face increased risk that their products will not be compliant in time. Manufactures would be well advised to work with committed, long-term NBs to confirm common expectations, as well as submission and assessment timetables.
Legacy Product Reclassification
It is likely that a relatively small portion of medical devices will be affected by reclassification. However, all manufacturers should familiarise themselves with the classification changes and determine whether those changes will have any impact on their devices.
Under the existing directives, all medical devices are classified from class I to class III. For devices that are reclassified, there could be a requirement for additional preparation and resources to demonstrate MDR compliance. Up-classified products will require more in-depth reviews from NBs, which will create a need for additional resources and time to complete the necessary additional conformity assessment procedures, with potentially several rounds of questions. These devices also will be subject to greater scrutiny in terms of available clinical data review by the NB. The latter also is true for implantable devices that do not change classification.
Some implants in the orthopaedic space, including devices that administer medication via inhalation and active therapeutic devices — such as closed-loop systems and automated external defibrillators (AEDs) — are among those affected by reclassification. The MDR also has introduced new classification rules to determine the correct class of software and devices incorporating nanotechnology.
There is no shortcut to understanding the impact of reclassification on products. In the U.S., the authorities outline a list of products and their classifications. The European approach, though, places much of the onus on manufacturers, who must review a set of rules and define the impact on their products. This process becomes even more complex in an environment where products can be classified under multiple rules, in which case they must comply with the highest classification standards.
Rationalising Product Ranges
There are some extremely valuable legacy products with strong market acceptance that help to bring choice to clinicians and healthcare systems.
However, for some legacy products, the cost of compliance may not be justifiable. Some manufacturers may use the MDR deadline as an opportunity to remove poor performing devices from the market — if the investment required to comply with MDR outweighs potential financial returns from the product. It also is likely that some ‘me too’ products could be eliminated as medical device manufacturers look to rationalise their offerings.
Before pulling devices from the market, manufacturers must consider whether they have alternative, better-performing products where the investment is worthwhile. This is likely, as most devices evolve over time to incorporate new designs and upgrades in line with postmarket surveillance data. If older, and potentially lower-cost, legacy products become unavailable, there could be an impact on costs for hospitals and healthcare providers. Manufacturers must consider the potential effects on the customer and, ultimately, the patient, when rationalising their products.
In the worst-case scenario, manufacturers that do not comply with the MDR will no longer be able to market their products in the EU. There are many factors to consider when evaluating the future of currently marketed products under the MDR requirements.
Early adopters of MDR are likely to see great benefit, but there needs to be careful consideration when it comes to the reclassification and rationalisation of products to ensure that customers and patients remain a priority.
About The Author
Paul Brooks is executive director at the Regulatory Affairs Professionals Society (RAPS). He has more than 25 years' experience within the medical device regulatory affairs environment and during his 35-year career he has worked with the British Standards Institution (BSI), where he served most recently as senior vice president, BSI Americas Healthcare and previously was head of the medical device EU Notified Body. He led BSI in achieving formal recognition as a recognised third party under FDA’s Center for Devices and Radiological Health (CDRH) and Health Canada’s Canadian Medical Devices Conformity Assessment System (CMDCAS) programs, and he is widely recognised as an expert on medical device regulations and regulatory issues.