Swissmedic Updates: New Timelines & Label Requirements

On the 20th of November 2024 Swissmedic communicated a new press release regarding a few amendments to the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) and clarified device registration obligations as per the Medical Device Ordinance (MedDO).

In summary, this press release focused on three (3) main topics and amendments related to the IvDO and MedDO:

• • New timelines for IVDs in the IvDO
  • Labeling requirements
  • Swissdamed registration deadline

The Implementation of New Timelines for IVDs in the IvDO

IVDs are used to examine body fluids and secretions as well as tissues outside the body. For example, rapid tests for COVID-19 or blood tests for early detection of cancer, are types of IVDs. Such devices are immensely impactful and are used on a daily basis in hospitals, laboratories, and by non-professionals as self-diagnostic tests. Hence, to ensure the same level of patient safety is in place in Switzerland, Swissmedic introduced the IvDO as the equivalent legislation to the Regulation (EU) 2017/746 on In vitro diagnostic medical devices (IVDR).

Consequent, to the implementation of the IvDO and the EU IVDR, it was clear that Notified Bodies could not meet the demand nor deadlines to allow such devices to comply with the new legislations. Therefore, as an interim solution, the EU introduced new transitional timelines to extend the ability for such devices to comply with the new regulations. These timelines are identified in Regulation (EU) 2024/1860. Such timelines are solely applicable under specific conditions and vary per device classification in order to minimize the risk of difficulties in the supply of these IVDs.

The Timelines are as Follows:

• • There is no extended transition period for class A self-certified devices, these devices shall already comply with the IVDR.
  • For class A sterile devices will be given a transitional period for placing on the market until December 31, 2029.
  • For class B devices, will be given a transitional period for placing on the market until December 31, 2029.
  • For class C devices, will be given a transitional period for placing on the market until December 31, 2028.
  • For class D devices will be given a transitional period for placing on the market until December 31, 2027.

(Source: Regulation (EU) 2024/1860: Regulation – EU – 2024/1860 – EN – EUR-Lex)

Considering the EU’s decision, Swissmedic has now confirmed that Switzerland will incorporate the aforementioned transitional timelines decided by the EU for IVDs into the Ordinance on IvDO and they shall be put into force at the beginning of 2025.

Labeling Requirements for Certain IVDs that will be Maintained Indefinitely

As of May 2022, the EU considers Switzerland to be a third country in the area of IVDs. Therefore, crucial facilitations and facilitators for the trade of these devices between Switzerland and the EU are no longer in place. Thus, to reduce the additional burden and costs for companies, the Swiss Federal Council took several measures, including the temporary simplification of labeling requirements for non-self-diagnostic IVDs that cannot be used by non-professionals.

Such simplification relates to the identification of the Swiss Authorised Representative (CH-REP) on either the label or IFU or in a document accompanying the device depending on the classification of the device and whether the device is deemed a legacy device.

For IVDs that are currently complying with the IVDR, the CH-REP identification requirements are as follows:

IVDs that are Currently Complying with the IVDD, the CH-REP Identification Requirements are as Follows:

Consequent to this, it was concluded that this measure has proven its worth, as it simplifies the distribution of certain IVDs on the Swiss market and contributes to maintenance of constant supply. Hence, it was announced that such requirements will now be maintained indefinitely.

Register Medical Devices and IVDs in Swissdamed By 1 July 2026.

The current provisions of MedDO and IvDO require that all devices on the Swiss market shall be registered accordingly with Swissmedic. Such registration will increase transparency and access to any particulars related to these devices, allowing all Economic Operators and other stakeholders, as applicable, to have all information continuously available.

Hence, Swissmedic is currently developing the ‘Swiss Database on Medical Devices’ (Swissdamed) device registration module. It is planned that parts of swissdamed’s device registration module will be available in 2025 for the registration of certain devices, on a voluntary basis. Nevertheless, the obligation to register devices is already identified in the MedDO and the IvDO, and will enter into force on 1 July 2026.

The above amendments have been adapted in the Ordinance on IvDO and will accordingly be put into force on January 1st, 2025.

For more information, you may read the press release at the following link: Anpassung der Verordnungen über In-vitro-Diagnostika und Medizinprodukte

Kindly note that the Swiss press release regarding the above summary is currently only published in the Swiss official languages, namely, German, French and Italian. Unfortunately, at this moment in time the official English translation of the communication is not yet available.

_____________________________________________

If you have questions or need support navigating the changes to the Swissmedic IvDO and MedDO regulations, which includes new timelines and label requirements, don’t hesitate to contact us. We’re here to help!

Learn how MedEnvoy can assist you:

• • • Swiss Authorized Representative
    • Swiss Regulatory Importer
    • EUDAMED Registration Management