MedTech Europe has said it remains held back by “slow and piecemeal implementation” of the new In Vitro Diagnostic Medical Device Regulation (IVDR) and Medical Device Regulation (MDR) framework.
IVDR is due to come into force in 2022, while MDR is in the final six months of implementation – and planned to come into effect on 26th May 2020.
MedTech Europe has issued a statement. The company comments: “As we have maintained throughout the Regulations’ transition periods to-date, this incomplete implementation by the EU Member States and European Commission threatens the continuity of patient access and care, both in Europe and in the more than 100 countries around the world that rely on the EU CE marking of medical technologies.
“MedTech Europe recognises and welcomes the increased political attention to the MDR in recent months, and the efforts of the European Commission and Member States to find solutions to that Regulation’s transition challenges, especially the low availability and capacity of Notified Bodies.
“While it is critical to maintain this political commitment to find pragmatic solutions to the MDR implementation, we also firmly believe that the EU is long overdue in devoting the same level of attention and energy to the IVD Regulation. The IVDR presents a considerable challenge since 85% of over 50,000 IVDs will need certification by Notified Bodies in the next 30 months (equal to more than 330 IVDs per week).”
MedTech Europe also said it was “alarmed” at the amount of organisations that have applied to be Notified Bodies under the IVDR regulation – which comes into force in two-and-half years – with only two of the ten organisations that have applied receiving their licence to operate as Notified Bodies.
The MedTech Europe statement can be read in full here.