¹ 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.¹⁰²

² Any person placing a medical device on the market must be able to prove that the device satisfies the fundamental requirements.

³ The Federal Council shall lay down the requirements that medical devices must satisfy. In particular it shall lay down:

a¹⁰³.

the fundamental safety and performance requirements;

b.

the rules of their classification;

c.

the languages used for the product information;

d.¹⁰⁴

the product labelling.

⁴ 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.¹⁰⁵

⁵ The Federal Council shall lay down the requirements for medical devices intended for use in clinical trials.

⁶ It may provide for the relaxation of requirements for medical devices produced and used only within health institutions.¹⁰⁶

⁷ It may provide for the permissibility of reprocessing and further use of single-use devices. It shall specify the relevant conditions.¹⁰⁷