The guidance provides an overview of the new legal requirements in force since 26 May 2021. It addresses all economic operators, including manufacturers, authorized representatives, importers, and distributors, all who are involved in the handling of medical devices in Switzerland. By contrast, users of medical devices are not considered economic operators and therefore the guidance does not apply to them.
Of particular interest are the following clarifications:
The following transition periods for their designation apply equally to both MDD/AIMDD and MDR products:
- High risk devices (class III, llb implantable and AIMD): 31 December 2021
- Medium risk products (non-implantable class llb, class lla): 31 March 2022
- Low-risk devices (class I) and systems and treatment units: 31 July 2022
These transitional periods apply not only to foreign manufacturers appointing a CH-REP, but also to their labeling the CH-REP with the name and address. Unlike the importer, it is not sufficient for the CH-REP to have its name and address solely affixed to a document accompanying the product.
Unlike for authorized representatives, importers have no transitional periods for complying with the labeling requirements. The labeling requirements apply with immediate effect. The importer may choose how to affix his name and address: on the product, or on the packaging, or on a document accompanying the product. Until further notice, these labeling requirements apply to both MDD/AIMDD and MDR products. The labeling may therefore be separate from the product, but it must, in all cases, accompany the product through the entire supply chain to the end user. Therefore, the labeling requirements is satisfied with a sticker on the label or on the instructions for use, but not with an imprint on the delivery bill.
The procedure for parallel imports remains unclear. Swissmedic points out that repackaged or relabeled products must be reported to it. Adapting the product information to the language requirements for Switzerland is permissible. However, it leaves open the question of whether and under what conditions the importer may label the CH-REP with the name and address but also how this is to be done.