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812.21 HMGLPTHLATER CH AI generated

Art. 45 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Requirements

TPA; Chapter 3 Medical Devices
Open official source Full Act (141 Articles) Machine-readable Markdown (.md)

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A medical device used in accordance with its intended use must not endanger the health of the user, the consumer, the patient or a third party. The intended performance must be demonstrated. Any person placing a medical device on the market must be able to prove that the device satisfies the fundamental requirements. The Federal Council shall lay down the requirements that medical devices must satisfy. In particular it shall lay down: a. the fundamental safety and performance requirements; b. the rules of their classification; c. the languages used for the product information; d. {note: Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} the product labelling. The Agency shall, in consultation with the State Secretariat for Economic Affairs, designate technical standards and common specifications which are appropriate for giving concrete form to the fundamental requirements. It shall designate, as far as possible, internationally harmonised standards. It shall publish in the Federal Gazette the titles of the designated technical standards and common specifications, also indicating the references or where they may be obtained. {note: Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} The Federal Council shall lay down the requirements for medical devices intended for use in clinical trials. It may provide for the relaxation of requirements for medical devices produced and used only within health institutions. {note: Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} It may provide for the permissibility of reprocessing and further use of single-use devices. It shall specify the relevant conditions. {note: Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).}

Art. 45 TPA · Requirements

A medical device used in accordance with its intended use must not endanger the health of the user, the consumer, the patient or a third party. The intended performance must be demonstrated.

Any person placing a medical device on the market must be able to prove that the device satisfies the fundamental requirements.

The Federal Council shall lay down the requirements that medical devices must satisfy. In particular it shall lay down: a. the fundamental safety and performance requirements; b. the rules of their classification; c. the languages used for the product information; d. the product labelling.

The Agency shall, in consultation with the State Secretariat for Economic Affairs, designate technical standards and common specifications which are appropriate for giving concrete form to the fundamental requirements. It shall designate, as far as possible, internationally harmonised standards. It shall publish in the Federal Gazette the titles of the designated technical standards and common specifications, also indicating the references or where they may be obtained.

The Federal Council shall lay down the requirements for medical devices intended for use in clinical trials.

It may provide for the relaxation of requirements for medical devices produced and used only within health institutions.

It may provide for the permissibility of reprocessing and further use of single-use devices. It shall specify the relevant conditions.

← Art. 44 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 46 TPA →

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Court Decisions Applying This Provision (7)

C-3910/2020 (Art. 45 Abs. 2 und 3 aBst. a HMG)
Spinal Implant Device Recall Upheld Due to Insufficient Clinical Data
Used to establish that the Z._______ and Y._______ rods, and the W._______ rod, do not meet the fundamental requirements for placing a medical device on the market.
SK 2017 162 · be (Art. 45 Abs. 1 HMG)
Marketing Medical Devices Beyond Approved Indications
Cited as a substantive legal basis for finding the appellant guilty of violating the Drug and Medical Devices Act.
C-1355/2008 (Art. 45 Abs. 2 HMG)
Company Fails to Prove Safety of Anti-Lice Products, Ban Upheld
Requirement for importers to prove compliance with basic requirements upon request.
52.2007.304 · ti (art. 45 e segg. LATer)
Optical Supplier v. Canton of Ticino (Eyeglass Distribution Restrictions)
Cited as the relevant federal legislation governing medical devices, indicating a comprehensive federal regulation that precludes Cantonal restrictions.
AGVE.2005.48 · ag (Art. 45 Abs. 1 HMG)
Hospital's CE Certification Requirement for Medical Device Bid
Cited in the reasoning to explain the general principle that medical devices must not endanger health, but not directly used in the final orders.
AGVE.2005.48 · ag (Art. 45 Abs. 2 HMG)
Hospital's CE Certification Requirement for Medical Device Bid
Cited in the reasoning to explain the principle that those marketing medical devices must be able to prove compliance with fundamental requirements, but not directly used in the final orders.
JAAC 67.94 (Art. 45 Abs. 2 HMG)
Market Surveillance Decision Addressed to Business Location Not Void If Owner Identifiable
Cited as a basis for the obligation of the importer to prove product conformity, and in conjunction with Art. 13 Abs. 1 let. c VwVG, for the principle of cooperation.