EMERGO SUMMARY OF KEY POINTS:

• Switzerland’s Competent Authority has established grace periods for Swiss device manufacturers that must find new Notified Bodies to renew CE Mark certification.
• Swissmedic’s process resembles that announced by French Competent Authority ANSM in late 2016 for affected French manufacturers.
• To qualify for Swissmedic’s program, affected manufacturers must have already initiated certification renewal efforts with new Notified Body partners.

A second European Competent Authority, the Swiss Agency for Therapeutic Products (Swissmedic), has now addressed the burgeoning issue of medical device manufacturers whose CE Mark certifications may become jeopardized by Notified Bodies ceasing operations.

Swissmedic has reported that stricter inspections of Notified Bodies (NBs) by regulators has already reduced the number of European NBs offering medical device CE Mark certification services from roughly 80 to about 60; as a result, some manufacturers find themselves suddenly having to obtain new NB partners in order to certify or re-certify their devices, a process that can take as long as one year to complete.

“From a regulatory point of view, the validity of EC certificates during this transitional period has not been fully clarified,” states Swissmedic. “This raises the question of whether medical devices can continue to be placed on the market for the first time with affected EC certificates.”

A harmonized effort to address the problem

European Union member states have ratified a harmonized approach to address this issue in which Competent Authorities may grant “periods of grace” that would allow continued marketing of affected devices while manufacturers work to restore their full CE Mark certifications.

Like French Competent Authority ANSM, Swissmedic has established its own approach to address affected device manufacturers based in Switzerland built on the aforementioned European harmonized process, even though Switzerland is not an official EU member.

The Swiss contingency plan

Swissmedic plans to allow affected manufacturers up to 12 months from the date of the “de-notification” or de-designation of their NBs to “restore the legal conformity” of their devices. During this period of grace, the Swiss Competent Authority will not prevent marketing of affected devices provided that they meet the following requirements:

• The device covered by the CE Mark certification in question poses no known or relevant risk
• The device continues to meet all essential requirements
• The device manufacturer has already begun the process of renewing the device’s CE Marking with a new NB
• The manufacturer must be able to provide an overview of its affected devices and certifications along with their status at any time during the period of grace

In order to qualify for Swissmedic’s period of grace allowance, a manufacturer must submit copies of its affected certifications and products, relevant declarations of conformity, proof that recertification with a new NB has begun and planned recertification timelines to the regulator within 30 days of the de-designation of the firm’s previous NB.

The Swiss Competent Authority also plans to continue issuing Certificates of Free Sale for Swiss manufacturers whose export devices are covered under periods of grace.

For more information, read our whitepapers on European Notified Body selection and unannounced NB audits.