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812.21 HMGLPTHLATER CH

Art. 47 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Registration and device identification

TPA; Chapter 3 Medical Devices
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Art. 47 TPA · Registration and device identification

The manufacturer must register medical devices in the information system specified in Article 62 c or in the European database on medical devices (Eudamed). It must also ensure that a unique device identifier is assigned to the medical device.

The Federal Council shall define the modalities for registration and for device identification. It may provide for exemptions from the obligations specified in paragraph 1.

It may regulate the obligations incumbent on the other economic operators concerned and on health institutions in connection with registration and device identification. It may, in particular, provide for an obligation to record and store the unique device identifiers of the devices acquired or supplied in certain categories.

The following are deemed to be economic operators: a. the manufacturers; b. the persons authorised to represent manufacturers with headquarters abroad (authorised representatives); c. the importers; d. the distributors; e. the natural and legal persons who combine medical devices in order to place them on the market in the form of a system or a procedure pack; f. the natural and legal persons who sterilise devices as specified in letter e before they are placed on the market.

← Art. 46 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 47a TPA →

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Court Decisions Applying This Provision (1)

JAAC 67.133 (Art. 47 Abs. 2 Bst. b HMG)
*H. pylori* Diagnostic Kit Direct-to-Consumer Sales Ban Upheld
This provision grants the Federal Council the authority to mandate licensing for certain medical devices, including in-vitro diagnostics, and forms the legal basis for the regulation in Art. 17 Abs. 3 MepV.