New Requirements Impacting European Notified Bodies’ Lead Times
Based on Emergo's recent experience assisting clients seeking CE Marking to sell their medical devices in Europe, some Notified Bodies are reporting that they are unable to take on new clients for the time being.
Some Notified Bodies have advised that they currently not providing quotations for CE Marking services to new clients, while other firms have quoted lengthy lead times for new CE Mark clients. Manufacturers needing to obtain recertification of their CE Marking may also be affected by these developments.
Notified Bodies’ lack of capacity to take on new clients may be attributed to two key factors: The advent of unannounced audits of these organizations by European regulators, which requires devoting considerable time and resources, and also higher rates of staffing changes at Notified Bodies affecting their ability to audit and certify clients.
Ronald Boumans, Senior Global Regulatory Consultant at Emergo and a former senior inspector at the Dutch Healthcare Inspectorate, says it may take a while for Notified Bodies to get their lead times back to normal.
“There are two factors at hand,” Boumans says. “First, the Notified Bodies have to allocate a significant number of staff to address unannounced audits, while at the same time dealing with increased supervision from Competent Authorities. This requires organizational changes on two levels.”
Second, Boumans observes that staff at some Notified Bodies are also moving positions at higher frequency. “As a result, some Notified Bodies see their own auditor pools dwindle,” thus requiring more time to audit their own clients for CE Marking.
“When the new Regulations come into force, the amount of work for Notified Bodies is expected to double at least,” Boumans adds, “so it may take a while before these organizations are less challenged in terms of lead times.”
More information on the role Notified Bodies play in Europe’s CE Marking process can be found in our whitepaper on Notified Body unannounced audits and Notified Body selection, as well as in our European medical device regulatory process chart.