Medtech trade groups have called for European authorities to accelerate implementation of incoming regulations to avoid a "cliff-edge" scenario that would cause "severe disruption" to product supply.
The medical device regulations are due to come into force in 12 months but the trade groups think the system will need to be fully functional months before the deadline to ensure there is enough time to recertify existing products.
Trade groups said the system is "very unlikely" to be ready in time, leading them to push the European Commission and member states to take "immediate action."
With less than 12 months to go until the medical device regulation takes effect, industry groups fear Europe is unlikely to achieve a smooth transition to the new regulatory regime, prompting groups, including MedTech Europe, to call for urgent action.
MedTech Europe has joined with six other organizations to set out the concerns in a letter to the Commission and member states that make up the European Union.
"The timely functionality of the system is critical to guarantee the continued supply of devices to health institutions. But as of today, achieving this is very unlikely thereby putting patient care across Europe at risk," the trade groups said.
The regulation features a fail-safe mechanism designed to ensure the continued supply of products in the event the system is not ready in time. However, the trade groups argue this mechanism, known as the 'grace period', has fundamental weakness.
One is the exclusion of several product categories that the trade groups think are critical to healthcare. There is a risk that supply of these products will be disrupted from May 2020 onward. And manufacturers of products eligible for the grade period face another barrier.
"The grace period is not working in practice because the certification bodies that exist today are unable to process all the files in time," the trade groups wrote.
MedTech Europe uploaded the letter a day after issuing feedback on a draft standardization request circulated by the Commission in February. The feedback identified "a number of critical concerns" with the proposal.
As written, MedTech Europe fears the draft will hinder the CE-marking of innovative devices and lead to a lack of alignment between the conformity assessment processes of different notified bodies.