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Interruptions to the supply of medical devices – recommendations for hospitals

30.04.2018

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)[1] 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.

[1] https://www.admin.ch/opc/en/classified-compilation/19995459/index.html

Medical devices regulation – the basics

  • As a rule, the manufacturers or distributors are themselves responsible for complying with legal requirements when they place medical devices on the market.
  • State-appointed and state-monitored private assessment bodies (conformity assessment bodies or notified bodies) check medical devices for conformity with the legal requirements on behalf of the manufacturers. After a successfully completed assessment, the conformity assessment body issues the corresponding EC certificates, which authorise the manufacturer to place the devices on the market.

Role of manufacturers
Medical devices may be placed on the market by manufacturers in Europe on their own initiative. The regulatory system for medical devices ("New Legislative Framework") facilitates fast and easy market access but, in return, demands a high level of individual responsibility from companies: The companies are responsible for ensuring that their devices are in conformity at all times.

Role of the supervisory authorities
Swissmedic is responsible for monitoring medical devices after they have been placed on the market and conducts market surveillance activities based on samples and using a risk-based approach for the purpose of assessing the conformity of medical devices with the legal requirements

Last modification 30.04.2018

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