🇨🇭 Switzerland — Medical Device Regulatory Gap Analysis

Pursuant to Art. 2 para. 1 of the Medical Devices Ordinance (MepV, SR 812.213): "Medical devices are products, including software, that are intended by their manufacturer to be used in human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations; and which do not achieve their principal intended action by pharmacological, immunological or metabolic means."

Classification is based on Annex VIII of MDR 2017/745 (EU), incorporated by reference via MepV Art. 15 into Swiss law. Devices are classified as Class I, Class IIa, Class IIb, or Class III based on intended purpose, risk, invasiveness, duration of use, and active principles. In Vitro Diagnostic (IVD) devices are separately classified under IVDV (SR 812.219.18) referencing IVDR 2017/746 Annex VIII.

Pursuant to MepV (SR 812.213) Art. 5–14, economic operators — comprising manufacturers, authorised representatives, importers, and distributors — each bear defined obligations regarding the placing on the market, putting into service, and making available of medical devices in Switzerland. The manufacturer bears primary responsibility for ensuring that a device is designed and manufactured in accordance with the requirements of MepV and that the conformity assessment procedure has been carried out.

Under MepV Art. 2 para. 1 lit. h: a "conformity assessment body" (Konformitätsbewertungsstelle) is a body that performs third-party conformity assessment activities, including calibration, testing, certification and inspection. In the Swiss context, conformity assessment bodies for medical devices are designated and monitored by the Swiss Accreditation Service (SAS) and notified to Swissmedic. These are the Swiss equivalent of "Notified Bodies" in the EU sense.

Switzerland regulates batteries and accumulators primarily through the Ordinance on Batteries and Accumulators (BattV, SR 814.321). Under Art. 3 BattV: "Batteries and accumulators that are placed on the market must not exceed the limit values for certain hazardous substances (mercury, cadmium, lead) and must be marked with the appropriate symbols to allow consumers to separate them from other waste." For medical devices containing batteries, additional requirements arise from MepV's General Safety and Performance Requirements (GSPR) — the device must be safe regardless of energy source, and power supplies must maintain device performance.

Under MepV (SR 812.213) Art. 3 referencing MDR 2017/745 Annex I (GSPR) §23.2 lit. j: "The label shall include, where relevant, an indication of the date until which the device, or part of it, can be used safely, expressed as the year and month ('use by date')." Separately, GSPR §23.2 lit. p requires the indication of: "the date by which the device should be used safely, expressed at least in terms of year and month where applicable." The shelf life (also called expiry date or use-by date) is a manufacturer-declared parameter, validated through stability testing and incorporated into the technical documentation.

Switzerland has its own REACH-equivalent framework through the Chemicals Act (ChemG, SR 813.1) and Chemicals Ordinance (ChemV, SR 813.11). Art. 3 ChemG defines a "chemical substance" as a natural or artificial chemical element or compound in the natural state or obtained by any manufacturing process. The Chemicals Risk Reduction Ordinance (ChemRRV, SR 814.81) implements specific restriction measures. Additionally, for medical devices containing CMR (carcinogenic, mutagenic, reprotoxic) substances, MepV Art. 3 referencing MDR Annex I §10.4 imposes explicit requirements: "Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device."

Switzerland implements RoHS-equivalent restrictions through the Ordinance on the Reduction of Risks from the Use of Certain Particularly Dangerous Substances and Products (ORRChem / ChemRRV, SR 814.81), specifically Annex 2.18 (restrictions on hazardous substances in electrical and electronic equipment). This parallels the EU RoHS Directive 2011/65/EU. The restricted substances for EEE are: lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (Cr VI), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP).

Under MepV (SR 812.213), manufacturers must assess whether changes to a certified or declared-compliant medical device require re-assessment or notification. MepV Art. 5 para. 3 lit. c requires manufacturers to have in place a quality management system that includes change management procedures. GSPR changes assessment flows from MDR Art. 120 transitional provisions (incorporated via MepV). For devices bearing an NB certificate, significant changes to the design or intended purpose require the NB to assess and supplement or reissue the certificate. Swissmedic's guidance on changes refers to the Swissmedic guidance document "Changes to medical devices and their documentation" and aligns with EU MDCG 2020-3.

In Switzerland, medical devices are generally available over-the-counter (OTC) without restriction unless specifically regulated otherwise. Unlike medicines, medical devices do not have a formal "prescription-only" classification system imposed by federal law. However, certain devices are subject to access restrictions under cantonal healthcare law, professional regulations, or specific MepV provisions. Swissmedic's role is product safety oversight, not sales channel regulation. The concept of "OTC medical devices" in Switzerland is therefore defined de facto by the absence of a prescription requirement rather than an explicit regulatory designation. Art. 65 of the Therapeutic Products Act (HMG) regulates advertising of medical devices to the general public.

Under MepV Art. 70 and the associated Swissmedic procedural guidelines, Swissmedic issues export certificates (also called Free Sale Certificates or Certificates of Free Sale) for medical devices manufactured in or distributed from Switzerland, at the request of the manufacturer or authorised representative. These certificates attest that the device is legally marketed in Switzerland and complies with Swiss regulatory requirements. They are used by importing countries that require such documentation for market access. Swissmedic also issues WHO-format certificates where requested.

Under MepV Art. 3 (GSPR via MDR Annex I §23.2 lit. l and §10): manufacturers must ensure that devices "can be transported and stored safely" under the conditions specified by the manufacturer. The label and/or instructions for use must indicate the storage and transport conditions (temperature range, humidity, pressure, light, vibration limits) necessary to maintain device safety and performance. Additionally, for temperature-sensitive devices (e.g., cold-chain biologicals, IVDs), specific cold-chain transport and storage validation is required. Swiss law does not have a standalone transport/storage ordinance for medical devices; requirements are embedded in MepV GSPR and Good Distribution Practice guidelines.

Switzerland regulates disposal of electrical and electronic equipment (including applicable medical devices) through the Ordinance on the Return, Taking Back and Disposal of Electrical and Electronic Equipment (VREG, SR 814.620). Art. 2 VREG defines "electrical and electronic equipment" as apparatus that are dependent on electric currents or electromagnetic fields to function properly. Art. 3 establishes a producer responsibility system: producers and importers must take back and ensure environmentally sound disposal of EEE placed on the Swiss market. For clinical/healthcare waste containing medical devices (single-use, biological contamination), cantonal hospital waste regulations and the Ordinance on the Movement of Waste (VeVA, SR 814.610) apply.

Under MepV (SR 812.213) Art. 2 and the GSPR (via MDR 2017/745 Annex I §17): "Software" intended by its manufacturer for one or more of the medical purposes set out in the definition of a medical device in Art. 2(1) MDR constitutes a medical device in its own right (standalone software/SaMD — Software as a Medical Device). Software incorporating artificial intelligence or machine learning algorithms intended for medical purposes — e.g., AI-based diagnostic decision support, AI image analysis, predictive analytics for patient outcomes — falls within the scope of MepV and is classified using the same classification rules (MDR Annex VIII, Classification Rule 11 for active devices with diagnostic function, and the MDCG 2019-11 guidance on qualification and classification of software). Swissmedic has confirmed it applies MDCG 2019-11 and MDCG 2021-24 (SaMD/AI specific guidance) to assess AI-based medical devices.