The Swiss Federal Office of Public Health, a division of the Federal Department of Home Affairs, has published an explanatory notice describing upcoming changes to the medical devices regulations.
The document provides additional clarifications on the changes made to each provision of the Medical Devices Ordinance, the country’s primary regulation on medical devices, which applies at the federal level. The changes are mostly intended to harmonize national legislation with the provisions of the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR), the basement of a new European framework for medical devices in order to ensure the same level of quality, safety, and security. This also constitutes an important part of the international cooperation between Switzerland and the EU in the sphere of medical devices, especially in placing them on the market and conducting ongoing monitoring and other post-market activities. However, it is also stated that the approach to post-market surveillance is still subject to negations. According to the document, Switzerland will also have access to Eudamed, the new European database for medical devices. At the moment, both parties are taking the steps necessary to ensure the uninterrupted availability of medical devices for healthcare professionals and patients irrespective of the changes to the applicable regulations.
It is expected that shortly the new regulations are created, they will cover the following aspects:
- Appointment of an authorized representative in Switzerland for the medical device manufacturers based in the EU/EEA.
- Obligation for all entities conducting operations with medical devices to register with Swissmedic, the country’s regulating authority in the sphere of medical devices.
- Obligation to report serious incidents not only via the European database but to Swissmedic as well.
- Recognition of EU conformity certificates.
Nevertheless, the implementation of all the steps described above will take time to complete.
Changes to the Swiss Medical Device Regulations in Detail
The document further describes the particular changes to be made to the respective provisions of the Medical Devices Ordinance. It also highlights some regulatory issues arising when applying such provisions.
1. Placing on the market. Since Eudamed is not fully operational, the Swiss national authority is unable to use it to carry out market surveillance regarding the medical devices placed on the market. Thus, the requirement to report on placing medical devices on the market to Swissmedic is reasonable. This is necessary to ensure the effectiveness of post-market surveillance activities carried out by the Swiss authority.
2. Recognition of certificates. In order to reduce the regulatory burden for medical device manufacturers, the recognition of conformity certificates is to be implemented. It is especially important in the context of preventing potential shortages in supply that could occur due to certain regulatory issues.
3. Reporting obligations. Under the new European Regulations, the designated notified bodies are obliged to report all cases of issuing, renewing, or revoking a certificate via Eudamed. Thus, it is important to ensure Swissmedic has full access to such records. During the transitional period, notified bodies shall report such issues directly to the Swiss regulating authority using a special online portal.
4. At the moment, a medical device manufacturer intending to market its products in Switzerland shall establish a local representation in the country. The appropriate local representatives shall be able to provide the authority with a copy of the technical documentation upon request. For this purpose, authorized representatives of foreign medical device manufacturers are encouraged to request and keep technical documentation from the very beginning since the authority usually expects the documentation to be provided within 7 days. Otherwise, it reserves the right to take special regulatory actions, including imposing restrictions on further marketing of the product.
5. Data availability. It is stated that access to information about medical devices constitutes one of the most important parts of regulatory improvements. If the product is subject to placement on the market under the notification procedure, the responsible party shall duly notify Swissmedic within 3 months from commencement of marketing. This period is implemented to provide additional flexibility for the parties involved and avoid shortages in supply. The same approach applies to change control – the responsible party shall directly notify Swissmedic about changes made to devices already placed on the market within 7 days (in the case of authorized representatives and importers, the calculation of such period shall commence from the date they become aware of such changes).
6. Registration number. Under the new European framework, a single registration number (SRN) will be used to track all the information related to a medical device. However, in the context of the issues related to the access of Swissmedic to the European databases, the Swiss authority will assign separate identification numbers to medical devices as well.
7. Safety reports. According to the amended regulation, the responsible party is obliged to notify Swissmedic of any reports or test results submitted via Eudamed. The same approach applies to the reposts related to incidents that occurred in other countries – if the device is also being marketed in Switzerland, the Swiss authority requires the appropriate report to be provided as well. This covers the reporting of all serious incidents associated with medical devices. In the case of foreign medical device manufacturers, such functions should be performed by their authorized representatives in Switzerland.
8. Restrictive measures. If the medical device placed on the market fails to comply with the applicable regulatory requirements, Swissmedic reserves the right to impose additional restrictions intended to mitigate the risks and ensure the safety of patients. In particular, the Swiss authority is entitled to prohibit further marketing of the product in question. Since this could be quite difficult to enforce in the case of foreign manufacturers, the appropriate restrictions would be applied to their local representatives and importers as the parties responsible for medical devices.
The Swiss authority acknowledges that it can take some time for foreign medical device manufacturers to appoint their local representatives in Switzerland. Thus, in order to create favorable conditions and prevent shortages in supply, a special transitional period will be introduced so that medical device manufacturers intending to market their products in Switzerland will be able to take the actions necessary to achieve compliance with the amended regulation. However, due to the important aspects outlined above, such as safety reporting and other post-market obligations, the requirement to appoint a local authorized representative in Switzerland cannot be waived.
In summary, the upcoming changes to Swiss medical device regulations are intended to ensure the effectiveness of cooperation between Swissmedic and the European authorities in terms of placing medical devices on the market and further post-market surveillance activities. The document pays special attention to the aspects related to access to the data on medical devices and information exchange in general.
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