In Europe, medical devices currently are regulated much the same way they have been since the 1990s. Now, almost 20 years and several major scandals later, EU officials are preparing a massive overhaul of the region's medical device regulatory directives in the hopes of modernizing the system—if only they could agree on what those changes should look like.
It wasn't supposed to happen this way, Erik Vollebregt, an expert on the EU's medical device regulatory and legal system, says. In 2008 and 2010, the European Commission was planning on making incremental updates to the EU's medical device regulatory system, says Vollebregt.
But shortly thereafter, the EU became embroiled in two major device safety scandals. In the first, French company, Poly Implant Prothese was found to have distributed breast implants manufactured using industrial, rather than medical grade, silicone. In the second, metal-on-metal hip implants were found to be failing much faster and worse than anticipated, requiring many patients to undergo corrective surgeries.
After this, Vollebregt says, "it was considered that a more in-depth revision of the rules was necessary." But while the need for reforms to the device directives has been clear for some time, the exact reforms to be made have been a matter of lengthy debate.
What Will Reforms Look Like?
In general, proposed reforms are set to affect different types of devices differently, Vollebregt explains. One EU regulation would combine and replace existing directives on active implantable medical devices (AIMD) and general medical devices, while the directive (and regulations) on in vitro diagnostics (IVDs) would be reformed as well as an EU regulation.
"The proposals will have far-going consequences for the medical devices sector for the EU" if they are enacted, Vollebregt told Regulatory Focus.
"The proposals will phase in general regulation on supply chain controls and a Unique Device Identification (UDI), but will also put in place a pan-EU system for vigilance, clinical trials, postmarket clinical follow up and many of the other aspects of EU regulation that are currently laid down in MEDDEV guidance documents," Vollebregt says. "The approval mechanism for 'innovative' and high-risk devices is still subject of debate between the member states, as is the extent to which reprocessing of medical devices is allowed on EU level (this is currently member state competence)."
These issues are quite controversial, notes Vollebregt. "The consequence of these new regulations is that all devices currently on the EU market will have to be CE marked again under the new rules – there is no grandfathering. Depending on the device concerned, this may require significant extra work to get the dossier up to the new standards," he explains. "Especially for the IVD industry this will be an immense job, because currently 80% of IVDs on the EU market is self-certified, while under the new IVD regulation 80% of the IVDs will be notified body certified. And, additionally, the standards for notified bodies will be raised, causing the number of available notified bodies to drop significantly. That means that companies may have to change notified body because their current one may not be around anymore to recertify their devices under the new regulations."
The entire process is a bit like trying to change a car's tires while it is being driven on the highway, he says.
There is much that remains uncertain about the process as it moves forward, Vollebregt notes. The European Commission has advanced one set of proposals, while the European Parliament favors substantial amendments to that proposal. Meanwhile, EU member states are still not in agreement "about crucial parts of the regulation, such as the approval mechanism for innovative and high-risk products," Vollebregt says.
"Under the current circumstances I don't expect the new rules to be adopted before half 2016," he concludes, “but it is not inconceivable that the politicians will surprise us with agreement during the current EU presidency”.
What Comes Next?
But what should device manufacturers and regulatory professionals expect, and what can they do to prepare for what comes next? Vollebregt will provide an overview of the current status of the revisions and what is likely to come next in an upcoming RAPS webcast on 11 March 2015.
Learn more about the webcast and how to attend on our website here.