MedTech Europe warned Wednesday significant challenges will stop manufacturers from using any of the options for keeping medical devices on the market after May 26, the date the EU's Medical Devices Regulation comes into force.
In a report, the trade group laid out why it thinks the three major methods to keep products on sale after the date are flawed.
MedTech Europe wants authorities to act quickly to fix the problems and ensure the thousands of devices affected by the transition to MDR stay on the market beyond May 26.
MedTech Europe has been sounding the alarm about the potential for MDR to disrupt product supply for most of the three-year transition to the new regulatory regime. With months to go until the end of the transition period, the trade group has significant, unresolved concerns about the ability of the EU infrastructure to ensure a smooth transition when the rules come into force on May 26.
The industry set out its concerns in a report covering the three ways devices can stay on the market after May 26. The standard route is to get certification from a MDR-designated notified body. However, MedTech Europe thinks that path is blocked off for new and existing devices alike.
The trade group points to multiple barriers stopping companies getting devices certified as MDR compliant. The lack of notified body capacity is perhaps the most widely discussed barrier, but MedTech Europe also highlights the negative impact of the absence of expert panels and gaps in the implementing acts and regulatory guidance.
"If these challenges remain unaddressed, neither existing nor new devices will be able to go through MDR certification by 26 May 2020," they wrote in the report.
Manufacturers that cannot obtain MDR certification by May 26 have two other paths. The first choice is to take advantage of the grace period, which allows manufacturers of devices certified under the old device rules to keep their products on the market until 2024. However, MedTech Europe thinks it will be "extremely difficult" for companies to use the grace period.
That prediction reflects "severe delays" experienced by companies seeking certification by the 55 notified bodies designated to assess devices under the outgoing rules. MedTech Europe thinks the bottleneck is being exacerbated by notified bodies imposing MDR-like requirements on devices reviewed under the old rules.
The third route for manufacturers is to ask national agencies for the right to keep devices on sale for a set period of time. The European Commission can extend that right to cover all of the EU.
However, MedTech Europe thinks the third option has its own problems, including the fact that the time-limited authorizations are unlikely to last long enough to enable companies to gain certification under MDR. As MedTech Europe thinks it will be impossible to fix these problems by May 26, it wants EU authorities to take steps to keep devices on the market using the two primary routes.
"The concept of EU-wide derogations is new under the MDR. The current Directives had only foreseen national derogations, for which manufacturers would need to apply 28 times (i.e., 'country by country') in order to keep a device available to patients. Before issuing EU-wide derogations, the new MDR still requires a national derogation first, and this process is currently very fragmented amongst Member States, with significant administrative hurdle," MedTech Europe wrote.
The group is urging the EU to rapidly publish missing implementing acts and guidance, while also quickly putting expert panels and additional notified body capacity in place. Those actions may help more companies get certified under MDR.
In parallel, the trade group wants the EU to fix perceived problems with the grace period by publishing guidance to allow devices to benefit from the grace period until May 26, 2024, while also enabling notified bodies to accelerate the processing of certification requests made under the outgoing rules.