Swissdamed actors module goes live

In the last week of June 2024, Swissmedic announced the go-live date for the actors module of the Swissdamed medical devices database. Commencing on 6 August 2024, the registration of economic operators in the medical devices sector represents a pivotal step forward for Switzerland’s regulatory framework. This development comes in response to the lack of an updated Mutual Recognition Agreement (MRA) with the European Union, which has prevented Swissmedic from accessing the European EUDAMED database since 21 May 2021.

Transition from the PDF form submission to the actors module

With the introduction of the actors module, the registration process for Swiss economic operators – comprising manufacturers, importers, and authorized representatives – will transition from the current PDF form submissions to a fully digital system. The new process, accessible via the Swissdamed website (www.swissdamed.ch), will replace the existing method of emailing applications to Swissmedic.

The key dates of this transition are the following:

• • July 26, 2024: This is the final date for submitting PDF forms for CHRN (Swiss Single Registration Number) registration, modifications, and mandate notifications.
  • August 6, 2024: The Swissdamed platform goes live, and from this date, all registrations must be done online through the new system.

Impact on existing registered operators

The transition will be seamless for the nearly 3,700 economic operators already registered with Swissmedic and holding a CHRN. Their data will be migrated into the new system, and they will be informed of the following steps via a letter sent to their registered contact persons. These operators will not need to re-register; instead, they will be required to verify their information once it is imported into Swissdamed.

Future developments: device registration

In addition to the actors module, Swissmedic has been actively working on the subsequent phases of the swissdamed database. In June 2024, a selected group of manufacturers and agencies began testing the initial device upload functionalities. The plan is to introduce the voluntary registration of specific medical devices in 2025, with compulsory registration slated for a later date.

Swissmedic aims to improve efficiency, reduce administrative burden, and enhance data accuracy by transitioning to a digital registration system. The ultimate goal is safeguarding public health by ensuring that only compliant and thoroughly vetted medical devices are available on the Swiss market.

Essential oils as medicines Products of chemical or biological origin intended or presented to have a medicinal effect on humans are medicinal products and regulated by the Swiss Therapeutic Products Act. Medicines requires the authorisation of Swissmedic before being placed on the Swiss market. However, some medicines’ groups can be subject to a simplified authorisation procedure, including essential oils.

Chiara Lai Regulatory Intelligence & Innovation Department 23/07/2024

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