With less than one year before the EU’s Medical Device Regulation takes effect, an industry group is raising increasing alarm about the lack of “essential guidance” and the shortage of notified bodies needed to certify products in compliance with the new requirements.
“[V]ery little progress has been made in the implementation of the regulation,” says the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) said in a new position paper. “Our members have invested considerable resources to be prepared for the MDR, but only as far as possible considering essential guidance information is still missing.”
So far, only two notified bodies — BSI and TUV SUD — have been designated under the MDR, and “there is no indication that a significant number of notified bodies will be designated in the next months,” COCIR said, adding that this is far short of the number needed to accommodate devicemakers.
Among other recommendations, the committee suggests that devicemakers that participate in the Medical Device Single Audit Program (MDSAP) should not have to undergo notified body certification.
“By now 38 notified bodies have applied for MDR,” Gert Bos, executive director and partner at QServe, told FDAnews. “Two received designation as you know, but one in the U.K. might lose it again, so they are not working full power on MDR reviews,” said Bos, who was formerly head of regulatory and clinical affairs at BSI Healthcare and head of the notified body at BSI-Germany.
Bos said the European Commission remains optimistic that it will designate up to 20 notified bodies by the end of the year, but most close observers in Brussels expect just ten NBs be designated by the end of the year in a best-case scenario, and 20 by the MDR implementation end of May 2020.
“Then all the work needs to be done during the grace period [for compliance of certain products until 2024]. Most critical will be the products that cannot use the grace period, and that will need an MDR certificate by May 2020, such as the re-usable surgical instruments. That will be extremely hard to manage in time,” Bos said.
Manufacturers of Class I devices that need notified body certification should be allowed to take advantage of the grace period, because many of these have been up-classified to Class IIa or higher, and were allowed to self-declare in the past. This means they will not have a valid NB certificate and will not qualify for the grace period that the MDR grants.
Call for Clarity
Because of the missing elements in the MDR framework and the uncertainties in interpreting requirements, “it is even more important that manufacturers can make full use of this grace period to prevent large disruption in the supply of medical devices,” COCIR said.
The committee said more clarity is needed on what’s considered a significant change and suggested that certificates should remain valid when changes are unrelated to design or the intended purpose of the device.
Bos concurred with the COCIR’s recommendations for what’s needed, but he said the solutions proposed may not be realistic. The European Parliament “is not expected to agree to an extension” of the implementation dates, he said, noting that many view the problem of notified body designation and the resulting bottleneck of reviews as largely the fault of member state authorities, so they should come up with the solution.
The International Medical Device Regulators Forum is pushing for MDSAP recognition. But there is no provision for this in the MDR legislation, so “this is not easy to implement,” Bos said.
Earlier this month, seven device and IVD stakeholders including MedTech Europe, released a joint statement urging the European Commission and member states to accelerate the implementation of the regulatory system to prevent a “cliff-edge” scenario (IDDM, June 7).
Read the paper here: www.fdanews.com/06-20-19-MDRAssessment.pdf.