NOTIFICATION
Addendum
The following communication, dated 21
November 2024, is being circulated at the request of the delegation of Switzerland.
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Title: Amendment to
the Ordinance on In Vitro Diagnostic Medical Devices
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Reason for Addendum:
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Comment period changed - date:
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[X]
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Notified measure adopted - date: 20 November 2024
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Notified measure published - date:
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[X]
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Notified measure enters into force - date: 1 January 2025 (extension
of transitional periods for certification of IVD products and flexibilities
for labeling requirements to IVD products); 1 July 2026 (mandatory
registration of the UDI)
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Text of final measure available from[1]:
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Notified measure withdrawn or revoked - date:
Relevant symbol if measure re-notified:
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[X]
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Content or scope of notified measure changed and text available from1:
The amending acts to the Swiss In vitro Diagnostic Medical Devices Ordinance
(IvDO) and to the Medical Devices Ordinance (MedDO) are attached to this
notification (in French).
https://members.wto.org/crnattachments/2024/TBT/CHE/modification/24_07904_00_f.pdf
https://members.wto.org/crnattachments/2024/TBT/CHE/modification/24_07904_01_f.pdf
New deadline for comments (if applicable):
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Interpretive guidance issued and text available from1:
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Other:
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Description: Content of changed notified measures
are summarized as follows:
In order to improve the safety and quality of medical
devices, Switzerland adapted its legislation on medical devices in line with
developments in EU law (Medical Devices Regulation, MDR and In vitro Diagnostic
Medical Devices Regulation, IVDR). The new legislations in Switzerland are
applicable since May 2021 for medical devices (MedDO) and May 2022 for in vitro
diagnostic medical devices (IvDO) like in the EU.
Transitional measures were notified to the WTO (G/TBT/N/CHE/258/add.1). Additional flexibilities for
labeling requirements to IVD products that are not intended to be self-diagnosis
are currently a temporary rule. The proposal foresees to adopt these
flexibilities for labeling requirements as a permanent rule.
In addition, on 13 June 2024, Regulation (EU) 2024/1860
amending the EU-MDR and the EU-IVDR entered into force in the EU and provides
in particular for an extension of the transitional periods in the EU provided
for in the IVDR and a gradual roll-out of Eudamed. The extended transitional
periods in the IVDR as well as the applicable conditions for their extensions
are transposed into the corresponding Swiss legislation to maintain the
equivalence with the European regulation as regards the transitional periods.
The registration of Unique Device Identification (UDI)
number with the Swiss authorities will become mandatory by July 1st 2026.
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[1] This information can be provided by including a website address, a
pdf attachment, or other information on where the text of the final/modified
measure and/or interpretive guidance can be obtained.