Therapeutic Products Act (TPA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 45 Requirements
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. 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: 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. 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 standa
Para. 1 — Second sentence amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 3 let. a — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 3 let. d — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 4 — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 6 — Inserted by No I of the
Art. 46 Procedures for assessing conformity
1 Any person placing a medical device on the market must be able to prove that it has been submitted to the prescribed procedures for assessing conformity. 2 The Federal Council shall regulate the prescribed procedures for assessing conformity. In particular it shall lay down: a. the types of procedures; b. the medical devices for which an authority for assessing conformity must be enlisted; c. the documents required and the length of time for which they should be archived. 3 It may: a. require clinical trials for certain medical devices, which will form an integral part of the proof of conformity; b. permit exemptions from the conformity assessment for certain medical devices or medical device groups.
Para. 3 let. b — Amended by No I of the FA of 22 March 2019, in force since 1 Aug. 2020 (AS 2020 2961; BBl 2019 1).
Art. 47 Registration and device identification
1 The manufacturer must register medical devices in the information system specified in Article 62c or in the European database on medical devices (Eudamed). It must also ensure that a unique device identifier is assigned to the medical device. 2 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. 3 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. 4 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 per
Art. 47 — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 47a Documentation requirements
1 The manufacturer must produce technical documentation. 2 The technical documentation must be such as to permit an assessment of the conformity of the medical device with the requirements of this Act. In particular, it shall also contain information and data on post-market surveillance. 3 The manufacturer must keep the technical documentation up to date. 4 The Federal Council shall specify for what medical devices what data and information must be included in the technical documentation, and how this documentation must be made available.
Art. 47a — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 47b Quality management
1 The manufacturer must establish and maintain a quality management system which is appropriate to the risk class and type of medical device and ensures compliance with the requirements of this Act. 2 The quality management system shall include, in particular, a risk management system and a post-market surveillance system.
Art. 47b — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 47c Disclosure requirements
1 The economic operators shall disclose to the competent authority, on request: a. all economic operators from whom they have acquired a medical device; b. all economic operators to whom they have supplied a medical device; c. all health institutions or health professionals to whom they have supplied a medical device. 2 The Federal Council shall specify for how long the information has to be kept.
Art. 47c — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 47d Financial coverage and liability
1 The manufacturer or the authorised representative must have sufficient financial coverage to compensate for damage caused by defective medical devices. 2 The authorised representative shall be jointly and severally liable with the manufacturer vis-à-vis the injured party.
Art. 47d — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 47e Additional obligations
1 The Federal Council may: a. make provision for mandatory notification for the placing on the market of certain medical devices; b. make provision for mandatory licensing for the placing on the market of certain medical devices, in particular for in vitro diagnostics; c. make provision for an obligation for economic operators and conformity assessment bodies to use Eudamed or the information system specified in Article 62c. 2 It shall regulate: a. the additional obligations of economic operators and health institutions, in particular concerning the registration of the manufacturers and the information to be provided in connection with implantable medical devices; b. the requirements for the manufacturers’ and authorised representatives’ persons responsible for regulatory compliance, and their other obligations.
Art. 47e — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 48 Dispensing and use
1 For the protection of health, the Federal Council may, for certain medical devices: a. make provision that they can only be dispensed on a medical prescription; b. lay down the necessary technical and operational conditions or a mandatory notification for their dispensing and use; c. attach to the dispensing of products the condition that the devices concerned must be traceable between their manufacture and their use and vice versa. 2 Article 26 applies by analogy to medical devices.
Para. 2 — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 49 Obligation of maintenance
1 Any person who uses a medical device commercially or who uses it on a third party shall be obliged to take all the necessary measures for the maintenance of such device to ensure the continued performance and the safety of the medical device. 2 The Federal Council may: a. specify the type of maintenance required for certain medical devices or certain classes of medical devices; b. regulate the procedure for proving that the obligation of maintenance and the relative requirements have been fulfilled; c. make the maintenance dependent upon the technical conditions.
Art. 50 Import and export
1 If required for the protection of health, the Federal Council may restrict or prohibit the import or export of certain medical devices. 2 If another state requests export certificates and attestations for medical devices which are to be imported, the Agency may, on request, issue these documents to the manufacturer or to the authorised representative with a registered office in Switzerland. 3 Any person exporting a medical device to a state with which Switzerland has concluded an agreement under international law for the mutual recognition of conformity assessments and procedures for medical devices must be able to demonstrate that the fundamental requirements referred to in Article 45 paragraph 2 are fulfilled.
Para. 2 — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 3 — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 51 Advertising
The Federal Council may, in order to protect health and prevent fraud, restrict or prohibit the advertising of certain medical devices and enact regulations concerning cross-border advertising.