Swissmedic has been contacted by several hospitals that are not currently receiving medical devices used for treatment because a manufacturer has restricted, or discontinued, the placing on the market of the relevant medical devices due to a certification gap (non-conforming status).
Investigations have revealed that the product certificates have expired. The certificates issued by a conformity assessment body (CAB) apply for a limited period and must be renewed at regular intervals. In this case, manufacturers are solely responsible for planning the certification process so as to ensure that the products are in conformity (certified), and therefore marketable, at all times.
In contrast with medicinal products, Swissmedic primarily plays a market monitoring role when it comes to medical devices. Since Swissmedic is not involved in the process of product certification between a conformity assessment body and the manufacturer, it cannot exert any influence on this process. It is not legally possible for Swissmedic to issue or extend EC certificates. The tightly restricted exemptions specified in therapeutic products legislation for the placing on the market of non-conforming medical devices (Art. 9, para. 4 and Art 12a of the Medical Devices Ordinance) are not applicable in such cases.
Recommendations to hospitals
- Swissmedic advises hospitals affected by supply shortfalls to immediately contact the manufacturers responsible directly in order to clarify the available options.
- All hospitals should check their product portfolio and their stocks in respect of security of supply, since supply bottlenecks due to certification gaps may recur.