- While the Medical Device Regulation's May 26 go-live date marks a significant milestone, MedTech Europe warned in a Wednesday statement that hurdles remain limiting the industry’s ability to "seamlessly supply certified devices under the new rules."
- The European trade group contends that despite the MDR going into effect, "some key pillars" of the necessary infrastructure are "still not fully operational or even in place," creating challenges in particular for many small and medium enterprises.
- CEO Serge Bernasconi argued the complexity of MDR and the delay in the new regulatory system's full readiness is resulting in European patients "losing their previous opportunities to be the first to benefit from critical medical technology innovation."
MedTech Europe had been sounding the alarm for some time about MDR's potential to disrupt product supply due to issues around the ability of the EU's infrastructure to ensure a smooth transition when the rules came into force on May 26. Now that the new regulatory regime has reached Wednesday's date of application, the trade group is once again warning that significant challenges remain unresolved that could negatively impact the sector.
A range of MDR uncertainties and potential problems are hovering on the horizon. While the medical device industry has resolved some near-term pressures as the delayed landmark regulation goes into effect, MedTech Europe on Wednesday listed a litany of challenges that are hindering the successful deployment of the new regulatory system.
These challenges include: non-harmonized interpretation and application of MDR rules across the EU; limited capacity among notified bodies, especially for certification of new and innovative devices; uncertainties with regards to pending discussions on the rules and agreements between the EU and other countries such as Switzerland; and unpredictable recognition of MDR certifications at the international level vis-à-vis regulatory approvals from other jurisdictions.
"Such challenges need ongoing attention and work by the EU Commission and Member States, if Europe is to ensure a workable system in the long-term," MedTech Europe said.
The trade group also highlighted an urgent need for attention to be given to the In Vitro Diagnostic Regulation, a major overhaul of the diagnostics sector slated to go into effect in 12 months.
"As with the MDR, the medical technology industry fully supports the new regulatory regime for IVDs but due to many factors, the system is not yet ready to support its implementation. Urgent solutions are needed here as well, and lessons learned from the MDR implementation should be taken into account," according to MedTech Europe.
The group added that it is working with the EU and stakeholders to "rapidly propose solutions to avoid disruptions" in supply of medical devices and diagnostics.