EMERGO SUMMARY OF KEY POINTS:

• French Competent Authority ANSM has issued new recommendations and procedures for manufacturers whose Notified Bodies cease CE certification and auditing support.
• “Orphaned” manufacturers may qualify for device marketing extensions in France under certain conditions until they obtain new Notified Body support.
• ANSM’s approach to the orphaned manufacturer issue is expected to be taken up by other European Competent Authorities, as well.

Medical device regulators in France have published new information for manufacturers on how to adjust to an expected decline in Notified Bodies in Europe due to more stringent CE Marking and quality auditing requirements in the near future.

The French Competent Authority, the National Agency for the Safety of Medicines and Health Products (ANSM), has assembled specific recommendations as well as a Q&A for steps manufacturers should take if their Notified Bodies are “denotified,” or no longer operating. ANSM is the first Competent Authority to compile such information, but Emergo consultants in Europe anticipate that other Competent Authorities will adopt identical or highly similar approaches as the rollout of the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) continues.

“The ANSM approach appears to be what’s to come in Europe,” says Richard Vincins, Vice President of Quality Assurance Consulting at Emergo. “Industry experts have coined the term ‘orphaned manufacturer’ to describe firms that are clients of a Notified Body that cannot remain accredited to current European medical device or IVD Directives, and will or cannot become accredited to the MDR or IVDR in the future.

“Clients of such Notified Bodies thus become ‘orphaned’ because even though they currently have valid CE certificates, transferring their business to another Notified Body may not be feasible or possible before those certificates expire,” Vincins continues. He adds that the number of Notified Bodies offering CE Marking and ISO 13485 auditing support in Europe is already falling, and that the number of manufacturers affected by denotification will accordingly increase.

ANSM’s recommendations for orphaned manufacturers

Medical device companies with valid CE certificates whose Notified Bodies become denotified may continue marketing their devices in Europe, according to ANSM, until the end of their certificates’ initial validity, and in “all instances” within a limit of 12 months following denotification of the Notified Body in question.

However, manufacturers have at least initiated efforts to sign up with new Notified Bodies as well as submit the following documents to ANSM in order to qualify for the denotification allowance:

• List of references for all medical devices and IVDs affected by the denotification, along with data on sales volumes and European member states where they are marketed
• Copy of most up-to-date CE certificates for all devices affected by the denotification
• Manufacturer attestation that all affected devices remain in compliance with “fundamental requirements”
• Identification of selected new Notified Body along with proof that certification efforts with the new entity have begun and anticipated date of finalization
• As soon as possible, audit report and new certificate from the manufacturer’s new Notified Body

Exceptions

In general, ANSM states that manufacturers with expired certificates or whose certificates’ validity dates do not occur after their Notified Bodies’ denotifications will not qualify for marketing extensions. In cases where a device is essential to public health or for which no alternative products are available, the Competent Authority will assess on a case-by-case basis whether to grant such extensions.

A challenged (and challenging) Notified Body landscape

Given European Competent Authorities’ increasing focus on denotification issues, just how challenged will manufactures find themselves in terms of selecting—and keeping—Notified Body partners? Some preliminary research conducted by Emergo in October 2016 could prove illustrative.

“We examined more than 1,000 of our medical device and IVD clients and their corresponding Notified Bodies,” explains Chris Schorre, Vice President of Global Marketing at Emergo. “We found that the 10 largest European Notified Bodies accounted for 87% of all Notified Body services utilized by those clients, and that the five largest Notified Bodies accounted for a commanding 67% of that business.”

Schorre says that while these figures may not completely reflect the overall European device market, they do indicate that smaller Notified Bodies will indeed be challenged to either comply with tougher new requirements from Competent Authorities and win business away from their larger competitors, or cease operations in the European market.

“With the mandate to conduct unannounced quality system audits, many smaller Notified Bodies have already chosen to drop out of the market, and we have seen a drop in the number of Notified Bodies listed in the NANDO database,” says Schorre. “As of October 2016, there were 50 companies authorized to audit manufacturers to the Medical Devices Directive, and I wouldn’t be surprised to see that number dwindle to 30 by the time the MDR comes fully into force in 2020.”

Emergo will continue monitoring the situation and report on additional European Competent Authorities’ approaches to the denotification issue as they are announced.

For more in-depth analysis of the changing European regulatory landscape, read our whitepapers on the Medical Device Regulations and In Vitro Diagnostic Regulations, or watch our webinars covering the MDR and IVDR.