The article provides an overview of the FAQ document addressing the key points related to notifications for medical devices.
Table of Contents
SwissMedic, a country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device notifications. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. In particular, the guidance is structured as a questions-and-answers document that provides answers to the most important questions raised by the industry. The scope of the guidance covers the key aspects related to notification obligations set forth under the existing regulatory framework.
Reporting Entities
The first question answered by the authority is related to notification obligations and entities involved in operations with medical devices to which these obligations apply. In particular, the authority explained, who is responsible for specific medical devices. According to the guidance, the following rules apply:
- For custom-made products, notification obligations apply to CH-based manufacturers, their authorized representatives, importers, and distributors.
- Notifications related to repackaged or relabelled medical devices should be submitted by the parties based in Switzerland.
- Notifications related to in-house products should be submitted by healthcare institutions responsible for these products.
- In the case of Class I medical devices (I, Is, Im, Ir, Ims), notification obligations apply only to medical device manufacturers based in Switzerland. The authority explicitly states that authorized representatives are excluded from the scope of responsible parties.
- Notifications related to systems or treatment units should be reported by the parties responsible for assembling them.
EU / non-EU Notification Rules
As further explained by the authority, medical devices of all the classes manufactured by the EU-based manufacturers and intended to be marketed in Switzerland are not subject to notification requirements. The same approach applies to Class I medical devices with a non-EU/EEA manufacturer, even though the device itself should comply with the Medical Devices Ordinance dated July 1, 2020 (MepV) which establishes the regulatory requirements for medical devices intended to be marketed and used in the country. At the same time, any party intending to place medical devices manufactured in third countries on the Swiss market should appoint an authorized representative in Switzerland.
Access to EUDAMED
The scope of the guidance also covers matters related to access to EUDAMED – a new EU-wide database for medical devices. The said database is comprised of several modules launched gradually. In this respect, the authority mentions that EUDAMED 2 is only accessible to authorities, while all entries on manufacturers and products in EUDAMED 3 are made by the companies themselves.
MDR and MDD
The authority also explains the approach to be applied with respect to medical devices placed on the market under the different regulatory frameworks – the old one, established by the Medical Devices Directive (MDD), and the new one, introduced by the Medical Devices Regulation (MDR). In this respect, the authority states the following:
- Class I medical devices that have been reported to Swissmedic in accordance with Article 6 (MepV), which refers to the declaration of conformity in accordance with the MDD, and now are compliant with the requirements set forth by the MDR, should be reported to the authority again.
- A medical device that was reported in accordance with the MDR before May 26, 2021, does not require reporting again.
Product Codes
According to the document, a GMDN product code could be obtained from the GMDN Agency and the UMDNS code – from the ECRI Institute. The authority also mentions that the EDMA codes can be used only for in vitro diagnostic (IVD) devices. When submitting a notification, the applicant should include the respective product code.
Furthermore, it is stated that a notification form should be completed for each medical device or product group. Should it appear that several devices are covered by the same product code, a collective notification can be submitted. In such a case, an applicant should submit a list of all the products included.
Additional Aspects
The document also outlines additional aspects to be considered by medical device manufacturers, their authorized representatives, and other parties involved with respect to notification requirements related to the products intended to be marketed and used in Switzerland. The matters addressed in the guidance include, inter alia, the following ones:
- Costs associated with the notification. According to the guidance, a fee of CHF 300 will be charged for each application.
- Applying for a local registration number. As explained by the authority, there is no need to apply for a CH Registration Number (CHRN) before submitting a notification, however, the said number should be obtained within 3 months from the date the product is placed on the market for the first time. It is also stated that the respective registration process should be handled separately and is not related to the notification procedure for medical devices.
- Timelines. According to the guidance, it will take approximately one month for the authority to process a report, provided it contains all the information and documentation required. At the same time, notification obligations will be deemed fulfilled once the application (notification) is submitted.
- Changes. As explained by Swissmedic, the changes to be reported to the authority include the changes to the name or address of the economic operator, the intended purpose, the classification, and the name of the device.
In summary, the present guidance document issued by Swissmedic provides an overview of notification requirements to be followed by the parties interested in placing medical devices on the country’s market. By the virtue of the guidance, the authority highlights the key points to be taken into consideration and explains the approach to be applied in order to ensure compliance with the requirements set forth under the existing regulatory framework.
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