With the EU’s new medical device regulation (MDR) coming into effect in less than a year, seven EU-based medical device industry groups on Wednesday called to accelerate the implementation of the regulation “to avoid severe disruption of product supply to patients and hospitals.”
While acknowledging a mechanism in MDR to allow for a grace period for certain devices that must meet the 26 May 2020 deadline, the groups explain why that mechanism has two fundamental weaknesses.
“1) Several healthcare-critical product categories are ineligible for the Grace Period, and no European solutions have been provided to keep these devices available after 26 May 2020, and 2) Even for those medical devices which are eligible, the Grace Period is not working in practice, because the certification bodies (‘Notified Bodies’) that exist today are unable to process all the files in time,” the groups say.
They also note how the new regulatory system will need to be fully functional three to nine months before the May 2020 deadline so that the thousands of devices currently on the market can go through a mandatory re-certification process.
“We thus call on the European Commission and Member States to accelerate the implementation of the regulatory system to prevent a ‘cliff-edge’ scenario for patients, healthcare professionals, and healthcare systems in Europe,” they write.
In addition to the joint statement, MedTech Europe on Wednesday also released a position paper on the proposed draft standardization request for MDR and the in vitro diagnostic regulation (IVDR).
MedTech Europe took issue with the first two annexes of the standardization request, explaining how they “lack several key horizontal standards that are vital to ensure safety and performance of devices” and that timelines associated with the annexes “appear to be misaligned with the enforcement dates of the new regulations.”
“Such a closed list of standards hinders CE-marking of innovative devices,” MedTech Europe said. “The number of the HArmonised Standards (HAS) consultants, who are engaged in the adoption process of standards for the entire medical technologies sector, is not sufficient compared to the number of standards to be assessed.”
MedTech Europe Joint Statement
MedTech Europe position on the proposed draft Standardisation Request for In-vitro Diagnostic Medical Devices (IVD) Regulation (2017/746/EU) and Medical Devices (MD) Regulation (2017/745/EU