Swissmedic, a Swiss authority responsible for medical device regulations, has published an information sheet dedicated to the marketing authorization of non-conforming medical devices. In particular, the document describes the rules and procedures to be applied for marketing and the use of non-conforming medical devices in Switzerland.
Marketing Authorization Without a Valid Certificate
According to the general rule, any and all medical devices intended to be marketed and used in Switzerland should be subject to the mandatory conformity assessment procedure. In the course of such a procedure, an authorized body shall assess compliance of the medical device in question with the applicable essential safety and performance requirements. An applicant (an entity responsible for the device – the manufacturer, its authorized representative, importer, or supplier) shall provide the evidence sufficient to demonstrate compliance with the aforementioned requirements.
At the same time, Swissmedic acknowledges that under certain conditions, it is important to make a particular device available to the patients and healthcare professionals, even if such a device hasn’t passed a mandatory conformity assessment procedure. As usual, such situations are based on exceptional needs related to public health protection. To ensure end expand the availability of vitally important medical devices, Swissmedic is entitled to grant marketing authorization for medical devices without a valid certificate, providing that:
the interested entity responsible for the device submitted the appropriate application, and
all related facts have been properly checked by the authority.
Authorization Eligibility Criteria
In its informational notice, Swissmedic outlines the main criteria to be considered when determining the applicability of the special authorization framework.
The initial application for marketing authorization could be submitted by any entity that intends to market the medical device in question in Switzerland. In particular, the Swiss authority provides the following list of the entities allowed to apply for authorization:
- Medical device manufacturer,
- Authorized representative,
- Professional who directly uses a device from another country.
According to the Medical Devices Ordinance (MedDO), the main Swiss regulation in the sphere of medical devices, there is a set of obligations the entity responsible for medical device shall duly carry out. These obligations include, inter alia, the following ones:
- In order to be allowed for marketing in Switzerland, a medical device should meet the essential requirements and satisfy the effectiveness claimed by its manufacturer. The entity applying for authorization would remain responsible for the medical device for the whole period of time it would be available. The applicant shall be able to provide the authority with sufficient safety and performance evidence upon request.
- Any incidents that occurred with the device should be reported to the regulating authority without any undue delay. Such a report should be provided by the responsible entity and by its professional users. The responsible entity shall also duly notify Swissmedic about any safety and corrective actions taken to reduce the potential or actual hazards associated with the device (including recalls) and inform the authority about the implementation process.
- A responsible entity shall sustain compliance with the post-market surveillance requirements to ensure that all necessary information is being properly collected. The scope of the information to be collected and kept should cover such aspects as safety, quality, the durability of a medical device and its performance when being used for the intended purpose initially determined by the medical device manufacturer. This information should be also used to identify problems and take appropriate measures.
- An entity that intends to place a medical device on the market should have an effective system for the recalls.
The authority states that the official fee payable for the application for marketing authorization is CHF 1,000.
Marketing Devices Without a Swissmedic Authorization
According to the Medical Devices Ordinance, in certain exceptional cases, individual medical devices could be placed on the market and used without a special authorization granted by Swissmedic. In order to be eligible for such an exclusion, the medical device should meet the following criteria:
- it should be intended to treat life-threatening conditions or to resolve the permanent impairment of a body function,
- there should be no similar device already placed on the market,
- it should be used only by healthcare professionals,
- the healthcare professionals shall duly inform the patients about the fact that the device has not been duly approved by the regulating authority, and also about the risks associated with the device,
- the patient shall provide his/her explicit consent to use the device.
If all the criteria described here above are met, the medical device could be used in Switzerland without the appropriate approval of Swissmedic. All benefits and risks associated with the use of the device should be duly assessed and evaluated by the healthcare professionals intended to use the device. In order to be allowed to apply such an approach, the manufacturer shall provide the authority with the documents demonstrating compliance with the aforementioned points. However, it is important to mention that the MedDO itself does not include the last two points.
At the same time, this approach should not be used to place medical devices on the market. Swissmedic emphasizes that the aforementioned special framework is intended to ensure the availability of vitally important medical devices to the patients, and its scope covers only the use of medical devices by healthcare professionals while placing non-conforming medical devices on the market and distributing them remains strictly prohibited.
General Conformity Assessment Procedures in Switzerland
The Medical Devices Ordinance also sets forth the general rules regulating conformity assessment procedures to be carried out before placing medical devices on the Swiss market. The document covers active implantable, in vitro diagnostic, and classical medical devices. The MedDO also implements certain exclusions establishing that the conformity assessment is not required for:
in-house in vitro diagnostic medical device – a device designed and manufactured by the healthcare institution (laboratories), and intended to be used only by the same institution, providing that the laboratory has an appropriate qualification, and there are no common technical specifications for such medical devices,
certain types of Class I medical devices (not sterile medical devices without measuring function),
medical devices that are subject to mandatory clinical investigation, and
custom-made medical devices.
The regulation also outlines special rules to be followed by a supplier performing the assembling of a system consisting of several medical devices, or composing a procedure pack. According to the conformity assessment rules, such a supplier shall confirm that:
all components are mutually compatible,
the users of a system or procedure pack would be provided with the detailed instructions necessary to ensure the use in a safe and efficient way,
an effective system of internal monitoring has been duly established and operates as intended.
Summarizing the information provided here above, a Swissmedic notice on non-conforming medical devices provides medical device manufacturers and other parties involved with the detailed guidelines and recommendations describing the particular procedures to be applied in order to make medical devices available to the patients under the special authorization framework or even without prior Swissmedic approval.
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