The article outlines the key points related to Swissdamed, the country’s new information system for healthcare products.
Table of content
Swissmedic, Switzerland’s regulatory agency in the sphere of medical devices, has published a document dedicated to Swissdamed, a new information system. The document highlights the most important aspects to be taken into consideration by medical device manufacturers, sponsors, and other parties involved.
The authority also reserves the right to make changes to the document, should such changes be reasonably necessary to reflect corresponding amendments.
Introduction to swissdamed
Swissdamed is the medical device information system operated by Swissmedic to fulfill its obligations under the Therapeutic Products Act (HMG) and the Medical Devices Ordinance (MepV). As a web application, swissdamed allows economic operators to register their data and the medical devices available in Switzerland, while also providing the public with access to information about these operators and their products.
Swissdamed is designed for various stakeholders, including the public, economic operators, healthcare institutions, and authorities. Swissdamed consists of two parts: a public section that is accessible to everyone and a restricted section for economic operators and authorities, which is not visible to the public.
The term “medical device” in this context also includes in vitro diagnostics and product groups according to Annex 1 of MepV. Economic operators can access their accounts in swissdamed upon request to Swissmedic, allowing them to manage their data and the information related to medical devices available in Switzerland.
The public section of swissdamed allows anyone to view publicly accessible data.
Liability
It is important to mention that economic operators are responsible for ensuring the accuracy, completeness, and timeliness of their data in swissdamed. They must verify the correctness of their information before publication. Swissmedic does not systematically control the content for accuracy, reliability, or completeness.
Therefore, the data may contain inaccuracies or errors, both technical and typographical. Swissmedic reserves the right to modify, delete, or comment on content at any time without prior notice.
Swissmedic excludes liability for any material or immaterial damages resulting from the use, non-use, or misuse of published information, technical failures, or any other issues related to swissdamed. Swissmedic disclaims any responsibility for external websites or web services linked to or from swissdamed.
The access and use of such websites are at the user’s own risk. Swissmedic has no control over the design, content, security, or offerings of these linked sites, and thus, disclaims any responsibility for them.
Copyright
All content within swissdamed is copyrighted by Swissmedic or the respective economic operators. Downloading or copying content does not transfer any rights.
Reproduction of any elements requires written consent from the copyright holders.
Language Availability
The swissdamed web application is available in German, French, Italian, and English. Economic operators choose the language in which their information is published.
Swissmedic does not provide translations and assumes no liability for inconsistencies or misinterpretations resulting from translations.
Data Privacy Statement
The relevant privacy statement informs customers about the type, scope, and purpose of collecting and using personal data on swissdamed. It also outlines their rights as per applicable data protection laws.
This description of data collection and processing is not exhaustive; other privacy statements or agreements may govern specific circumstances. Swissmedic is the data controller for swissdamed and the primary contact for data protection matters unless stated otherwise.
When accessing swissdamed, certain data is stored in log files, including IP address, date, time, browser request, and transmitted information about the used device. These data are analyzed using analytical tools and are stored and processed in Switzerland.
Swissdamed processes personal data only to the extent necessary to provide a functional website or web application and user-friendly content and services. Data is processed based on user inputs, such as when setting up an account.
Mandatory fields are marked as such, as they are required for fulfilling legal tasks or the user’s request.
The following data is collected and processed:
- Company contact details (name, address, UID number)
- Actor contact details (language, phone number, email address)
- Contact person details for actors (name, phone number, email address)
- PRRC (Person Responsible for Regulatory Compliance) details (name, phone number, email address, address)
- Mandate contact details (company name, address, email address, validity date),
- User contact details (name, email address)
Data is processed based on user consent, which can be withdrawn at any time. However, such withdrawal does not affect the legality of the data processing carried out before the withdrawal.
Laws and regulations determine which of the data is processed and in what form. Under Art. 55 para. 1 MepV, personal data of contact persons and PRRC must be provided during registration in swissdamed.
The entered data is used to fulfill our tasks, particularly ensuring the safety and vigilance of medical devices. Swissmedic assigns a unique Swiss Registration Number (CHRN) to economic operators based on the data they report.
Non-personal data may be used for independent evaluations of the long-term safety and performance of products or the traceability of implantable products.
Swissmedic also processes personal data within the legal framework for the following purposes:
- Collecting health data during market surveillance and vigilance,
- Verifying the reliability and professional qualifications of vigilance contact persons or PRRCs.
The medical device information system contains data such as product data, economic operator data, system data for managing and adapting the information system, and user authentication data. This system may also obtain data from the European medical device database and cantonal electronic systems and transmit data to them.
Swissmedic may publish data such as product information, information about economic operators and products, certification details, and information about market surveillance measures like recalls and non-compliance notifications. Swissmedic processes and stores personal data as long as necessary to fulfill contractual and legal obligations or for the purposes pursued by the processing.
Personal data may be retained for the period during which claims can be made against Swissmedic, or as required or permitted by law, or for legitimate business interests like evidence and documentation purposes. Personal data collected by Swissmedic is only retained as long as necessary to fulfill the relevant purpose.
Legal requirements or other obligations may lead to longer retention periods. This privacy policy applies to the entire swissdamed web application. It may be changed or adjusted at any time without notice.
The current privacy policy can be accessed on the Swissmedic website, also available in French, Italian, and English.
Conclusion
In summary, the present document published by Swissmedic outlines the terms of use for the new system and also describes in detail the way personal data would be collected, stored, and processed.
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