Survey: Expected Shortage of Notified Bodies Under EU MDR/IVDR
Findings from a recent survey of notified bodies (NB) in Europe suggests the audits needed for compliance with the new medical device regulation (MDR) will not be completed in time, TÜV SÜD Product Service GmbH VP Bassil Akra said Wednesday at 2018 Regulatory Convergence.The survey conducted by Team-NB was designed to assess the impact of a contentious issue with regard to the ongoing transition to the new EU MDR and in vitro diagnostic regulation (IVDR). This relates to the projected availability and readiness of NBs to conduct audits necessary for the certificates of compliance.
Out of a total of 58 NBs for devices, 35 responded to the survey. According to Akra, most of the respondents are well-known NBs and all others will likely cease to exist under the new EU regulatory landscape over the associated increase in requirements to obtain designation.
Akra noted that the survey findings debunk the outlook regulators gave to manufacturers that the new regulation was going to enable greater interest and participation from NBs.
Only 7 of the 35 respondents had a joint assessment and not a single NB will be designated this year, Akra said. Device firms “will not have a NB audit on time for the new regulation,” he added.
Akra and John Wilkinson, director of devices at the UK’s Medicines and Healthcare products Regulatory Agency, stressed that those firms that have yet to have a comprehensive strategy in place to ensure compliance after the shift to MDR/IVDR are in for a rude awakening.
Some of the steps recommended by the speakers during a conference session on the EU regulation include conducting an impact analysis, early renewal of current certificates and making decisions on which devices to keep in a portfolio. “Not all devices will make it,” Akra argued. Analyses should also consider how the new EU requirements may impact those in other non-EU countries that are relying on the CE Mark as well.
This story was updated on 9 October to correct the name of the organization that conducted the survey.
Click on this link for more news coverage on RAPS' 2018 Convergence from Regulatory Focus.