European notified body TÜV SÜD said the EU medical device regulation finalized May 5 includes specific clinical requirements that are not consistent with the MEDDEV 2.7/1 Rev. 4 guidance on clinical evaluations for device manufacturers and notified bodies.
In the 3-year transition to the new EU regulation, the Munich, Germany-headquartered group decided to extend the implementation timeline for the MEDDEV 2.7/1 Rev. 4 state-of-the art methods of clinical evaluation to May 25, 2020.
TUV SUD said the extension is only possible if the requirements on clinical evaluation and active post-market surveillance of the applicable directive MDD and/or Active Implantable Medical Devices Directive are fulfilled.
In the implementation timeline for MEDDEV 2.7/1 Rev. 4, from July 31, 2017 to May 25, 2020:
Although not legally binding, the EU MEDDEV guideline promotes a common approach for EU notified bodies to undertake conformity assessments for CE marking.
Medical device manufacturers are already facing significant hurdles in the EU because of tougher clinical data requirements and the steep drop in the number of notified bodies available to approve medical devices for sale in the EU.
Higher standards under the EU’s MDR have cut the number of notified bodies significantly, and more are expected to drop out this year. Waiting lists for product approvals are now longer, and some CE marks have been suspended without warning or have not been renewed in time, according to Gert Bos, executive director and partner at Qserve Group in the Netherlands.
The remaining notified bodies are becoming more strict in granting CE marks, he said. This is in part because MEDDEV 2.7.1guidelines published last year were meant to align with provisions in the MDR and provide general principles for clinical evaluations and have introduced more thorough pre- and post-market data collection requirements.
High-risk products under the new MDR must be supported by the manufacturer’s own pre-market data for the device under review. The data also must be gathered from real-world use instead of focus groups. According to Bos, more than 90 percent of devices currently marketed in the EU might not currently meet these requirements.
The MDR requires post-market clinical data for currently marketed devices, as well as a plan to generate such data for any new product being launched. This requires manufacturers to implement new procedures for lifecycle management and traceability.
“The window of opportunity is closing” as the MDR is being implemented, and notified bodies are getting more and more selective in terms of which manufacturers they choose to work with,” Bos said.
Another important change is that these notified bodies are now focusing on full compliance to the legal requirements instead of looking for sufficient evidence on conformity, he said.
“In the transfer to the EU MDR and IVDR, there will not be any harmonized standard in the early days, so the conformity assessment cannot use the presumption of conformity via use of standards as is widely practiced,” he said.
Notified bodies will find it harder to disagree with the various agencies’ recommendations. “The essence of the notified body work will not change, but the reality might well find more black and white strict interpretations” (IDDM, July 10).
Read the TÜV SÜD notice here: www.fdanews.com/08-29-17-TUVSUD.pdf.