¹ For the purposes of verifying conformity, the authorities responsible for monitoring under Article 76 may, without providing compensation:

a.

demand the proof and information required;

b.

take samples;

c.

have the samples tested or submitted to laboratory examination;

d.

enter and inspect, during normal working hours and with advance notice or, if necessary, unannounced, the business premises and facilities of natural or legal persons who have an obligation to provide information;

e.

consult documents and demand that they, or additional information, be provided in one of the official languages of Switzerland or in English.

² If a manufacturer or a natural or legal person who assembles systems or procedure packs under Article 22 paragraphs 1 and 3 EU-MDR¹¹⁹ fails to fulfil their obligations under Article 66, Swissmedic may impose appropriate measures to protect health, up to and including prohibiting the making available on the market or the putting into service of the devices in question.¹²⁰