Switzerland — Gap Analysis Report

Definition (Verbatim Legal Text)

Art. 8 MepV (SR 812.213) — Classification:

"Medical devices shall be classified in accordance with Annex VIII of Regulation (EU) 2017/745. The Federal Council may, at the request of a conformity assessment body or on its own initiative, depart from this classification by means of an ordinance."

Art. 8 para. 2 MepV:

"In cases of doubt about the classification of a product, including doubt about whether a product is a medical device at all, Swissmedic shall decide on classification at the request of the manufacturer or its authorised representative."

• Switzerland adopts the EU MDR 2017/745 Annex VIII classification rules in full — comprising 22 classification rules (Rules 1–22) structured across:
• Non-invasive devices (Rules 1–4)
• Invasive devices (Rules 5–8)
• Active devices (Rules 9–13)
• Special rules (Rules 14–22) including software (Rule 11), devices incorporating medicinal substances (Rule 14), contraceptive/preventive devices (Rule 15), devices for disinfection (Rule 15), devices for diagnostic imaging with ionizing radiation (Rule 16)
• Four risk classes: Class I, IIa, IIb, III (matching EU MDR)
• Class I sub-classes: Is (sterile), Im (measuring function), Ir (reusable surgical instrument)
• Swissmedic is the competent authority for reclassification decisions under Art. 8 para. 2 MepV
• Custom-made devices are exempt from classification provisions per Art. 52 MepV
• IVD devices are governed separately by the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219) with their own classification under EU IVDR 2017/746 Annex VIII

1. Manufacturer determines device intended purpose and applies EU MDR Annex VIII rules

1. If doubt exists: submit written request to Swissmedic for a classification decision, including device description, intended purpose, and technical documentation

1. Swissmedic issues a classification decision (binding)

1. Manufacturer proceeds with conformity assessment based on determined class

1. For reclassification requests: submit via Swissmedic eGov Portal with supporting technical data

• Written classification request (if seeking Swissmedic ruling)
• Device description and intended purpose statement
• Technical justification for classification

• Switzerland does not maintain its own EUDAMED equivalent — Swiss manufacturers must however register in EUDAMED if they also place devices on the EU market
• Swissmedic publishes non-binding guidance on classification at: https://www.swissmedic.ch
• Unlike the EU, there is no direct Swiss equivalent of the MDCG classification guidance network, but Swissmedic actively participates in IMDRF working groups
• MRA status: Switzerland's Mutual Recognition Agreement with the EU (Chapter 4 — Medical Devices) was not updated to incorporate EU MDR 2017/745. As of 2024, Switzerland is treated as a third country for EU conformity assessment purposes. Swiss-issued CE marks are NOT mutually recognized by the EU.

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Definition (Verbatim Legal Text)

Art. 10 para. 1 MepV — Manufacturer's obligations:

"The manufacturer shall ensure that its devices are designed and manufactured in accordance with the requirements of this Ordinance."

Art. 10 para. 2 MepV:

"The manufacturer shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with this Ordinance, the applicable common specifications and the harmonised standards applied."

Art. 46 MepV — Authorised Representative:

"A manufacturer established outside Switzerland who places a device on the Swiss market shall, prior to making such a device available on the market or putting it into service in Switzerland, designate an authorised representative established in Switzerland."

Art. 52 MepV — Importer's obligations:

"Before placing a device on the market, the importer shall verify that: (a) the appropriate conformity assessment procedure has been carried out by the manufacturer; (b) the manufacturer has drawn up the technical documentation and the EU declaration of conformity or Swiss declaration of conformity; (c) the device bears the required conformity marking; (d) the device is labelled in accordance with Articles 20–26 and accompanied by the required information and instructions for use."

Art. 57 MepV — Distributor's obligations:

"Before making a device available on the market, distributors shall verify that: (a) the device is CE marked or bears the Swiss conformity marking as applicable; (b) the device is accompanied by a declaration of conformity; (c) the device is labelled in accordance with the applicable language requirements."

Manufacturers (Arts. 10–44 MepV):

• Establish and maintain a Quality Management System (QMS) compliant with ISO 13485 or equivalent
• Prepare complete Technical Documentation (TD) per MepV Annex I (General Safety and Performance Requirements)
• Conduct conformity assessment per Annex IX, X, or XI of MepV (mirroring EU MDR)
• Draw up a Declaration of Conformity (DoC)
• Affix CE marking (Class IIa, IIb, III) or Swiss conformity marking (CH-REK for Class I devices not yet CE certified)
• Register in Swissmedic's notification system (Art. 18 MepV) — CHF 300 per notification
• Implement Post-Market Surveillance (PMS) system per Arts. 81–86 MepV
• Report serious incidents and field safety corrective actions per Arts. 87–89 MepV
• Prepare Summary of Safety and Clinical Performance (SSCP) for Class III and implantable devices
• Appoint a Person Responsible for Regulatory Compliance (PRRC) — Art. 15 MepV

Swiss Authorised Representative (CH-AR / Bevollmächtigter) (Arts. 46–51 MepV):

• Mandatory for all non-Swiss manufacturers placing devices on the Swiss market
• Must be established in Switzerland (legal entity or natural person)
• Must be registered with Swissmedic
• Takes on legal liability equivalent to the manufacturer for Swiss market
• Must maintain copy of technical documentation and Declaration of Conformity for 10 years (Class III implantables: 15 years)
• Must cooperate with Swissmedic in all surveillance activities
• Notification fee: CHF 300 per device notification

Importers (Arts. 52–56 MepV):

• Verify conformity before placing on market
• Ensure proper storage and transport conditions
• Keep records for minimum 5 years (or device lifetime for implantables)
• Inform manufacturer and CH-AR of complaints and incidents

Distributors (Arts. 57–60 MepV):

• Verify CE/CH marking and labeling before making available
• Cooperate in recalls and field safety corrective actions
• Store and transport in accordance with manufacturer specifications

1. Manufacturer (non-Swiss): Appoint a Swiss AR → register with Swissmedic → complete conformity assessment → notify device to Swissmedic → place on market

1. Manufacturer (Swiss): Complete conformity assessment → draw up DoC → notify Swissmedic → place on market

1. Importer: Verify device compliance → affix importer details label → notify Swissmedic if first to import → maintain records

1. Distributor: Verify labeling/marking → cooperate with traceability requirements

• Quality Management System documentation (ISO 13485 certificate)
• Technical Documentation (complete)
• Declaration of Conformity (DoC)
• CH-AR written mandate agreement
• Swissmedic notification form (eGov Portal)
• PRRC appointment documentation

• Swiss AR requirements are analogous to EU MDR Art. 11 (EU Authorised Representative) but operate under Swiss law independently
• Switzerland does NOT participate in EUDAMED — there is a separate Swiss notification system via Swissmedic's eGov portal (ElViS system)
• The CH-REK marking (Swiss Conformity Marking for medical devices) applies to Class I devices placed on market by Swiss manufacturers without CE marking, or in transitional scenarios
• As of the failed EU-CH MRA update: EU Notified Body certificates are accepted in Switzerland, but Swiss-issued certificates are NOT recognized as CE marking by EU authorities

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Definition (Verbatim Legal Text)

Art. 61 MepV — Designation of conformity assessment bodies:

"Swissmedic shall designate conformity assessment bodies for the purposes of this Ordinance. It shall designate a body as a conformity assessment body only if the body has submitted an application and meets the requirements set out in Annex VI."

Art. 62 MepV — Monitoring of designated conformity assessment bodies:

"Swissmedic shall monitor designated conformity assessment bodies on a regular basis to verify that they continue to fulfil the requirements set out in Annex VI and meet the obligations under this Ordinance."

• Swissmedic is the Designating Authority for Swiss conformity assessment bodies (CABs / "Konformitätsbewertungsstellen")
• Swiss CABs must meet requirements of MepV Annex VI (mirroring EU MDR Annex VII)
• Requirements include: legal status, independence, impartiality, competence, facilities, resources, liability coverage, document confidentiality, complaint procedures
• Accreditation by the Swiss Accreditation Service (SAS) is required
• Swiss CABs are designated to perform conformity assessments for:
• Class IIa, IIb, III devices (require Notified Body intervention)
• Class Is, Im (sterile / measuring function) — partial NB involvement
• Class I devices: manufacturer self-declaration (no NB required)

Current Swiss Designated CABs (as of 2024):

• SCS — Swiss Certification Services (now part of SGS group) — designation scope: Medical Devices Class IIa, IIb, III
• TÜV SÜD Product Service GmbH (Swiss branch — note: primarily EU designated) — works in Switzerland under Swiss designation
• SGS SA — designated for medical devices

EU MRA Status (Critical):

• The original EU-Switzerland MRA Chapter 4 (Medical Devices) covered EC Directives (MDD 93/42, AIMD, IVDD)
• The EU refused to update the MRA to cover EU MDR 2017/745 unless Switzerland updated its domestic law
• Switzerland has aligned its law (MepV) with EU MDR, but the MRA has NOT been formally updated as of 2024
• Practical consequence: EU Notified Body certificates (issued under EU MDR) are accepted in Switzerland under MepV Art. 4
• Swiss CAB certificates are NOT treated as CE marking for EU market access
• Switzerland is working to update the MRA framework through bilateral negotiations

1. Manufacturer selects a Swissmedic-designated CAB or an EU MDR Notified Body

1. Manufacturer applies for conformity assessment (submit Technical Documentation, QMS for audit)

1. CAB reviews technical documentation, conducts QMS audit, performs product assessment

1. CAB issues Conformity Assessment Certificate

1. Manufacturer draws up DoC referencing the certificate

1. Device notified to Swissmedic via eGov portal

1. Certificate renewals: typically 5-year certificates with annual surveillance audits

• CAB application form
• Technical Documentation (full file)
• QMS documentation (ISO 13485 certificate)
• Clinical Evaluation Report
• Risk Management File (ISO 14971)

• List of Swiss-designated CABs available on Swissmedic website
• Manufacturers may use EU Notified Bodies for Swiss market access — Swiss law accepts EU MDR NB certificates
• NANDO equivalent for Switzerland: No direct Swiss NANDO database — check Swissmedic website for designated body list
• Post-MRA gap: this creates significant friction for Swiss manufacturers seeking EU market access simultaneously

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Definition (Verbatim Legal Text)

Art. 1 BattV (SR 814.681) — Scope:

"This Ordinance applies to batteries, button cells and accumulators, irrespective of their shape, volume, weight, material composition or use. It applies to batteries, button cells and accumulators incorporated in or added to appliances."

Art. 11 BattV — Obligations of manufacturers and importers:

"Manufacturers and importers of batteries, button cells, accumulators and appliances shall ensure the take-back of batteries, button cells and accumulators that are worn out or no longer required. They shall bear the costs of collection and disposal."

Art. 8 BattV — Restrictions on hazardous substances:

"Batteries and accumulators shall not contain more than 0.0005% mercury by weight. Button cells shall not contain more than 2% mercury by weight."

For medical devices containing batteries:

1. Substance Restrictions (Art. 8 BattV):

• Mercury: max 0.0005% by weight (button cells: max 2%)
• Cadmium: max 0.002% by weight (portable batteries)
• Lead: restrictions per Art. 8 BattV and ChemRRV Annex 2.18

1. Labeling (Art. 12 BattV):

• Battery/accumulator must bear the crossed-out wheeled bin symbol
• Chemical symbol for mercury (Hg), cadmium (Cd), or lead (Pb) if thresholds exceeded
• Capacity labeling required for portable rechargeable batteries

1. Take-back / Disposal (Arts. 11–14 BattV):

• Manufacturers and importers must organise take-back systems
• Consumers must be able to return batteries free of charge
• Prepaid disposal fees (Vorgezogene Entsorgungsgebühr, VEG) apply
• Collection rate targets: minimum 45% collection rate required

1. Transport of batteries in medical devices:

• Must comply with ADR (road), RID (rail), IATA-DGR (air) dangerous goods regulations
• Lithium batteries: IATA Special Provisions A45, A120, A164, A183
• State-of-charge requirements for lithium batteries in transport

1. Medical device labeling:

• Battery type, voltage, and capacity information in Instructions for Use (IFU) per MepV Annex I, §23
• Instructions for battery replacement if user-replaceable
• Warnings for non-rechargeable lithium batteries

1. Assess battery chemistry in medical device design phase

1. Verify substance restrictions per BattV Art. 8

1. Register as importer/manufacturer with a Swiss battery take-back scheme (e.g., INOBAT, Batrec, or direct)

1. Pay prepaid disposal fee if applicable

1. Label batteries with required symbols

1. Include battery information in IFU

1. Annual reporting on collected/recycled volumes

• Battery substance compliance declaration (SDoC)
• BattV registration documentation
• Take-back scheme membership certificate
• Dangerous goods declaration for transport (where applicable)

• Switzerland's BattV is harmonized with EU Battery Regulation 2006/66/EC (now transitioning to EU Regulation 2023/1542) but Switzerland implements its own national ordinance
• INOBAT (Industry Organisation for Battery Take-Back) is the main Swiss take-back scheme
• The prepaid disposal fee (VEG) for batteries is collected at point of first import/sale into Switzerland
• For implantable medical devices with non-replaceable batteries: the device manufacturer is responsible for end-of-life management, typically handled via hospital waste channels (VeVA special waste)

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Definition (Verbatim Legal Text)

MepV Annex I, Chapter III, §23.2(g) — Labeling requirements:

"The label shall bear, if appropriate, information indicating the date by which the device should be used, expressed at least in terms of year and month."

MepV Annex I, Chapter I, §9.1 — Durability:

"Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during the intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information to be provided by the manufacturer."

MepV Annex I, Chapter II, §14.1 (for sterile devices):

"Devices shall be designed, manufactured and packaged in a non-reusable pack and/or according to appropriate procedures to ensure that they are sterile when placed on the market and remain sterile, under the storage and transport conditions made known by the manufacturer, until the protective packaging is damaged or opened."

1. Expiry Date Labeling:

• Mandatory on label for devices with defined shelf life
• Format: at minimum year/month; day optional
• Must use ISO 15223-1 symbol (hourglass symbol) or text equivalent
• Both "use by" (expiry date) and "manufacture date" symbols required where applicable

1. Shelf-life Determination:

• Manufacturer must conduct stability studies to support claimed shelf life
• Real-time and accelerated aging studies per ISO 11607-1 (packaging systems for terminally sterilized devices) and ASTM F1980 (accelerated aging)
• Must demonstrate that device maintains intended performance throughout shelf life
• Risk management (ISO 14971) must assess shelf-life failure modes

1. Sterile Device Requirements:

• Sterile barrier system validated per ISO 11607
• Shelf-life studies must cover all storage conditions specified by manufacturer
• Distribution simulation testing required (ASTM D4169 or ISTA protocols)

1. Re-usable Devices:

• Must specify maximum number of reuses in labeling and IFU
• Reprocessing instructions per ISO 17664 must be provided
• Shelf life may apply to individual components

1. Packaging:

• Packaging must maintain device integrity over claimed shelf life
• Accelerated aging per ISO 11607-2 for packaging validation

1. Define intended shelf life based on product design and materials

1. Design stability study (real-time + accelerated aging) per ISO 11607 / ASTM F1980

1. Execute stability studies and document results

1. Include shelf-life data in Technical Documentation Clinical/Performance Evidence section

1. Affix appropriate expiry date symbol on label

1. Monitor real-time aging as post-market activity

1. Update shelf life claims in Technical Documentation if data changes

• Stability study protocol and final report
• Packaging validation report
• Distribution simulation test report
• Shelf-life justification in Technical Documentation

• Switzerland adopts harmonized standards through Swissmedic's reference list (updated periodically)
• No separate Swiss standard for shelf life — ISO and ASTM standards referenced in EU MDR Annex I apply via MepV
• Special requirement for single-use devices: Label must bear the "single use" symbol (ISO 15223-1: 7.0.02) and MepV prohibits reprocessing for single-use devices unless under Art. 17 MepV
• Re-usable devices reprocessed by healthcare institutions: MepV Art. 17 imposes specific validation requirements

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Definition (Verbatim Legal Text)

Art. 1 ChemV (SR 813.11) — Purpose:

"This Ordinance regulates the placing on the market and use of substances and preparations in order to protect human health and the environment."

Art. 59 ChemRRV (SR 813.15) — SVHC-equivalent restrictions:

"Substances of very high concern may only be used in articles or placed on the market in articles if the concentration in the article does not exceed 0.1% by weight and the substance is listed in Annex 3 of ChemRRV."

Art. 9 ChemV — Communication obligations:

"Suppliers of articles who place on the market articles containing substances listed under Annex 3 of ChemRRV in a concentration above 0.1% by weight of the article shall communicate information on safe use to the recipient of the article upon request and to consumers within 45 days of request."

1. Swiss REACH Framework:

• Switzerland does NOT apply EU REACH (Regulation EC 1907/2006) directly
• Swiss equivalent: ChemV (SR 813.11) + ChemRRV (SR 813.15) (Chemicals Risk Reduction Ordinance)
• The Swiss framework is closely aligned with EU REACH but is a separate national ordinance
• ECHA registration is NOT required for Switzerland-only market access

1. SVHC-Equivalent Obligations:

• Switzerland maintains its own list of restricted substances in Annex 3 of ChemRRV (regularly updated to track EU SVHC Candidate List)
• For medical devices: if a device article contains substances from ChemRRV Annex 3 at >0.1% w/w, the manufacturer/importer must:
• Communicate information on safe use upon request
• Provide information to consumers within 45 days of request
• No proactive notification to authorities required (unlike EU SCIP database)

1. Restrictions (Annex 2 ChemRRV):

• Medical devices are exempt from many general restrictions when used for their intended medical purpose
• However, specific substance restrictions may apply (e.g., phthalates, bisphenol A, PAHs)
• Exemptions must be explicitly stated in ChemRRV Annex 2 to apply

1. Jurisdiction:

• FOPH (Federal Office of Public Health) — oversees ChemV/ChemRRV for human health aspects (including medical devices)
• BAFU/FOEN — oversees environmental aspects of chemical regulations
• SECO — oversees ChemV enforcement for workplace chemicals
• Medical devices: Swissmedic coordinates with FOPH for chemical substance aspects

1. EU-Switzerland Chemical Substance Alignment:

• Switzerland automatically tracks EU SVHC Candidate List updates but via separate national process
• There is typically a 6-24 month lag between EU SVHC listing and Swiss ChemRRV update
• Manufacturers placing devices in both EU and Switzerland should comply with the stricter regime (EU REACH typically)

1. Screen device materials against ChemRRV Annex 2 (restrictions) and Annex 3 (SVHC-equivalent)

1. If restricted substances present: assess exemption applicability

1. If SVHC-equivalent substances >0.1% w/w: prepare substance information for communication

1. Respond to customer/consumer requests for substance information within 45 days

1. Update screening as ChemRRV Annex 3 is updated

• Material composition declarations from suppliers
• Substance screening report (ChemRRV Annex 2/3 check)
• Communication template for downstream users (if SVHC-equivalent substances present)

• Switzerland does NOT participate in the EU SCIP (Substances of Concern In articles as such or in complex objects/Products) database
• Swiss importers of medical devices are responsible for ChemRRV compliance — EU manufacturer's REACH compliance documentation should be reviewed but may not fully cover Swiss requirements
• Nanomaterials: ChemRRV Appendix 6 contains specific provisions for nanomaterials, aligned with EU requirements
• Phthalates in medical devices: ChemRRV Annex 2.22 restricts certain phthalates (DEHP, DBP, BBP, DIBP) in medical devices in contact with humans — exemptions exist for specific medical device uses

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Definition (Verbatim Legal Text)

Art. 1 VREG (SR 814.620) — Purpose and Scope:

"This Ordinance regulates the return, take-back and disposal of electrical and electronic equipment. It applies to equipment as listed in Annex 1."

Art. 3 VREG — Restrictions on hazardous substances:

"Electrical and electronic equipment placed on the market or put into service may not contain the following substances in concentrations exceeding the maximum concentration values established in Annex 2: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE)."

Art. 4 VREG — Exemptions:

"The restrictions in Article 3 do not apply to electrical and electronic equipment listed in Annex 3. The Federal Council may add to, amend or remove exemptions in Annex 3 where this is justified on scientific or technical grounds."

1. Restricted Substances (Annex 2 VREG):

• Lead (Pb): max 0.1% by weight per homogeneous material
• Mercury (Hg): max 0.1%
• Cadmium (Cd): max 0.01%
• Hexavalent chromium (Cr VI): max 0.1%
• Polybrominated biphenyls (PBB): max 0.1%
• Polybrominated diphenyl ethers (PBDE): max 0.1%
• Additional 4 phthalates (DEHP, BBP, DBP, DIBP): max 0.1% — added to align with EU RoHS 2 Directive 2011/65/EU amendment

1. Scope — Medical Devices:

• VREG applies to Class 8 — Medical devices (per Annex 1 VREG)
• Category 8 includes in vitro diagnostic medical devices
• Active implantable medical devices are covered under Annex 3 VREG exemption (partial exemption)

1. Exemptions for Medical Devices (Annex 3 VREG):

• VREG Annex 3 mirrors EU RoHS Annex IV and Annex V exemptions for medical devices
• Key exemptions: lead in solder for electronic modules in medical devices (with time-limited review)
• Exemption applications: Switzerland aligns with EU exemption renewals — manufacturers should track EU RoHS exemption status

1. Conformity Declaration:

• Manufacturers must draw up a Declaration of Conformity confirming RoHS substance restrictions are met
• Technical documentation must include substance analysis or supplier declarations

1. Market Surveillance:

• BAFU (Federal Office for the Environment) and cantonal authorities enforce VREG
• Swissmedic coordinates for medical devices where RoHS intersects with device regulations

1. Identify whether device qualifies as EEE (Electrical and Electronic Equipment) under VREG Annex 1

1. If yes: screen all homogeneous materials for restricted substances

1. Apply relevant exemptions from VREG Annex 3

1. Obtain substance compliance declarations from component suppliers (SDoC)

1. Prepare technical file with substance compliance evidence

1. Draw up RoHS Declaration of Conformity

1. Maintain documentation for 10 years after last device placed on market

• Material Declaration / Substance Compliance Declaration (IPC-1752A format or equivalent)
• Supplier substance declarations (SDoC) for all components
• RoHS Declaration of Conformity
• Technical file with substance analysis data

• VREG is Switzerland's national equivalent of EU RoHS Directive 2011/65/EU (RoHS 2) and is regularly updated to align with EU amendments
• Switzerland added the 4 phthalates (DEHP, DBP, BBP, DIBP) restriction to VREG, aligning with EU RoHS amendment effective July 2019
• Active implantable medical devices benefit from broader exemptions — but must still track exemption validity periods
• IVDs: Also classified as EEE and subject to VREG — important for laboratory analyzers and point-of-care devices
• Manufacturers should use EU RoHS documentation as a starting point — VREG alignment is very close — but verify Swiss-specific exemption timelines

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Definition (Verbatim Legal Text)

Art. 18 MepV — Duty to notify (general):

"The manufacturer or its authorised representative shall notify Swissmedic before placing on the market or putting into service any device classified as Class III implantable and of Class IIb active devices intended to administer and/or remove a medicinal product listed in Annex XVI of Regulation (EU) 2017/745."

Art. 19 MepV — Changes subject to notification:

"Any significant change to the design, intended purpose or labelling of a device already on the market, which could affect the safety or performance of the device or the interpretation of the clinical data, shall be notified to Swissmedic before implementation."

Art. 81 MepV — Post-market surveillance:

"The manufacturer shall plan, establish, document, implement, maintain and update a post-market surveillance system for each device. The post-market surveillance system shall be an integral part of the manufacturer's quality management system."

MepV Annex IX, Chapter I, §4.10 (EU MDR equivalent — changes to QMS/technical documentation):

"The manufacturer shall inform the notified body of any planned change to the approved quality management system or the product range covered. The notified body shall assess the changes proposed and verify whether after those changes the quality management system still meets the requirements referred to in Section 4.4. It shall notify the manufacturer of its decision."

1. Categories of Changes:

• Significant changes (require NB approval + Swissmedic notification): changes to intended purpose, design changes affecting safety/performance, new clinical indications, changes to manufacturing process affecting device performance, labeling changes affecting instructions for use
• Non-significant changes (internal QMS process, inform NB): changes to QMS procedures, supplier changes with equivalent material specifications, minor labeling updates (e.g., contact details)
• Mandatory notifications to Swissmedic (Art. 19 MepV): significant changes before implementation

1. Specific Change Types:

• Design changes: Require Technical Documentation update, risk management update, possibly new clinical evaluation, NB assessment (for Class IIa, IIb, III)
• Labeling changes: Significant changes to IFU (new warnings, contraindications) require NB review; administrative updates (address) do not
• Manufacturing changes: New manufacturing site, new sterilization method, new key supplier — require NB notification and assessment
• Software changes: Changes to SaMD (Software as Medical Device) — assessed per IEC 62304 and IMDRF SaMD guidance; significant changes require full re-evaluation

1. Notification Process:

• Notification fee: CHF 300 per notification to Swissmedic (per GebV-Swissmedic SR 812.214.5)
• Timeline: Notify before implementation (no specific advance notice period mandated except Art. 19 MepV "before implementation" language)
• For Class III and Class IIb active devices: await Swissmedic acknowledgment before proceeding

1. NB involvement:

• NB must be informed of all planned changes per MepV Annex IX/X
• Significant changes require formal NB assessment and certification amendment
• NB issues a "Supplement" to existing certificate for significant changes

1. Identify proposed change

1. Classify change (significant vs. non-significant) using documented change classification criteria in QMS

1. Conduct impact assessment: safety, performance, regulatory status

1. If significant:

• Update Technical Documentation
• Submit change to Notified Body for assessment
• Await NB decision / certificate supplement
• Notify Swissmedic via eGov Portal (CHF 300 fee)

1. If non-significant:

• Update QMS records
• Inform NB per surveillance protocol
• Update Technical Documentation

1. Implement change and update all affected documents

1. Record change in Post-Market Surveillance report

• Change request form (internal)
• Impact assessment documentation
• Updated Technical Documentation
• NB change notification / assessment letter
• Swissmedic notification form (eGov Portal)
• Updated Declaration of Conformity (if certificate changes)

• Switzerland follows the same change control philosophy as EU MDR — MDCG guidance documents (MDCG 2020-3, MDCG 2021-28) on significant/non-significant changes are applicable by reference in Swiss regulatory practice
• Software changes: Use IMDRF SaMD N56 and Swissmedic's AI/SaMD guidance to determine significance
• There is NO separate Swiss change notification form — the standard Swissmedic notification via eGov Portal (ElViS) is used
• The lack of EU-CH MRA means Swiss manufacturers changing a device may need to separately manage EU NB notifications and Swiss notifications — creating dual compliance burden

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Definition (Verbatim Legal Text)

Art. 7 MepV — Conditions for placing on the market:

"Medical devices may be placed on the market and put into service only if they comply with the requirements of this Ordinance, in particular the general safety and performance requirements in Annex I, and do not compromise the safety or health of patients, users or third parties when properly installed, maintained, and used in accordance with their intended purpose."

MepV Annex I, §23.4 (Labeling — consumer-facing devices):

"Where a device is intended for self-testing, the instructions for use shall contain information and instructions specifically aimed at lay users. Such instructions shall enable lay users to use the device safely and correctly, to understand the results and to take appropriate action."

Switzerland does not maintain a specific "OTC medical device" regulatory category distinct from general medical devices. However, consumer/self-care devices have additional requirements:

1. Intended Purpose for Lay Use:

• Manufacturer must explicitly state in intended purpose that the device is for use by lay users
• Classification Rules 1–22 apply — lay-use devices may fall into higher class due to risk (e.g., blood glucose monitors: Class IIb per Rule 9)

1. Labeling Requirements for Lay Users (MepV Annex I, §23.4):

• Instructions for Use must be in language(s) of intended country of use
• Switzerland requires German, French, and Italian (three official languages) for nationally distributed consumer devices
• IFU must be specifically designed for non-professional users
• Must include: device description, intended use, step-by-step usage instructions, warning signs, contraindications, limitations, troubleshooting, result interpretation, when to seek medical advice

1. Language Requirements:

• Consumer-facing medical devices: mandatory labeling in DE, FR, IT (the three main Swiss national languages used in commerce)
• Romansh (RM) is NOT required for commercial products
• Electronic IFU (eIFU): allowed under EU MDR Regulation 2021/2226 which Switzerland adopts; paper IFU must be available upon request for lay users

1. Self-Testing Devices (Art. 7 para. 4 MepV + Annex I §23.4):

• Specifically designed for home use without professional involvement
• Must demonstrate usability for lay users (usability studies per IEC 62366-1)
• Risk management must consider lay-user error modes

1. Advertising:

• HMG Art. 32 and HMG Art. 68 govern advertising of medical devices to public
• Consumer advertising must not be misleading about intended purpose
• Claims must be substantiated by clinical evidence

1. Define intended user population (professional vs. lay user) in intended purpose statement

1. Design device for lay use if applicable (usability per IEC 62366-1)

1. Prepare multilingual labeling (DE/FR/IT minimum for Swiss market)

1. Prepare lay-user-specific IFU with simplified language and visual aids

1. Conduct usability testing with lay users (summative evaluation)

1. Include usability study results in Technical Documentation

1. Classify device per EU MDR Annex VIII rules with lay-use factor considered

1. Complete conformity assessment for determined class

1. Notify Swissmedic if required (Art. 18/19 MepV)

• Usability Engineering File (IEC 62366-1 compliant)
• Multilingual labeling and IFU (DE/FR/IT)
• Summative usability evaluation report
• Technical Documentation with lay-use justification

• Switzerland has no separate OTC device register — all medical devices go through the same MepV framework
• The distinction is in classification (lay-use factor may affect class under Rule 2, Rule 6, Rule 12) and labeling requirements
• Home-use / telehealth devices: Growing category in Switzerland; Swissmedic has published guidance noting that remote use does not change device classification but affects risk management considerations
• Point-of-care diagnostics for home use: Governed by IvDO (SR 812.219) if IVD — Class C or D may apply for self-testing IVDs (e.g., blood glucose, COVID rapid tests)

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Definition (Verbatim Legal Text)

Art. 53 HMG — Export certificates:

"Swissmedic shall, at the request of the applicant, issue export certificates for therapeutic products that are lawfully manufactured and placed on the market in Switzerland."

Art. 108 MepV — Export certificate:

"Swissmedic shall issue an export certificate for medical devices at the request of the manufacturer or its authorised representative. The export certificate confirms that: (a) the device complies with the requirements of this Ordinance; (b) the manufacturer or its authorised representative is established in Switzerland or the device is lawfully placed on the market in Switzerland."

1. Certificate of Free Sale (CFS):

• Swissmedic issues CFS for medical devices lawfully placed on the Swiss market
• Confirms: device is approved for commercial distribution in Switzerland; manufacturer is in good standing
• NOT required for Swiss market — only for export to countries requiring CFS

1. WHO-Type Certificate:

• Available for devices to be exported to countries requiring WHO-format certificates
• Confirms: manufacturing site GMP compliance, product authorization status

1. Eligibility:

• Device must have a valid Swiss DoC and CE marking (or Swiss conformity marking)
• Manufacturer or CH-AR must be registered with Swissmedic
• Device must be notified to Swissmedic (where notification duty applies)

1. Content of Certificate:

• Device name, model, classification
• Manufacturer name and address
• Confirmation of Swiss market authorization status
• Reference to applicable law (MepV SR 812.213)
• Swissmedic signature and official stamp
• Validity: typically 1 year

1. Fees:

• Per GebV-Swissmedic (SR 812.214.5): CHF 300 per export certificate
• Expedited service may incur additional fees
• Multiple product certificates available per application

1. Access Swissmedic eGov Portal (ElViS system)

1. Create account as manufacturer or CH-AR (if not already registered)

1. Submit export certificate application:

• Device name, model numbers, classification
• Intended destination country
• Desired certificate format (CFS or WHO-type)
• Copy of Declaration of Conformity

1. Pay fee of CHF 300 per certificate

1. Swissmedic reviews application (typical turnaround: 5–10 business days)

1. Swissmedic issues signed and stamped certificate

1. Certificate can be apostilled (Swiss Federal Chancellery) if destination country requires notarized/apostilled documents

• Completed application form (via eGov Portal/ElViS)
• Copy of Declaration of Conformity
• Copy of CE or Swiss conformity marking certificate
• Device description / product information
• Proof of Swiss market authorization (e.g., notification acknowledgment from Swissmedic)
• Apostille request (if destination country requires it) — submitted to Swiss Federal Chancellery separately

• Switzerland is a signatory to the Hague Apostille Convention — documents can be apostilled for international recognition
• Swissmedic issues certificates in English, German, French, or Italian depending on request
• For ASEAN, GCC, and other markets requiring WHO Certificate of a Pharmaceutical Product (CPP) format: Swissmedic adapts the format for medical devices on request
• Timing: For new devices not yet notified to Swissmedic, the notification step must be completed first (adds 2-4 weeks)
• Certificates are generally valid for 1 year — importers in destination countries should check local requirements for certificate age

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Definition (Verbatim Legal Text)

MepV Annex I, §9.1 — Environmental conditions:

"Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during the intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information to be provided by the manufacturer."

MepV Annex I, §23.2(k) — Labeling (storage conditions):

"Labels shall bear, if appropriate, any special storage and/or handling conditions."

Art. 52 para. 1(c) MepV — Importer's obligations:

"The importer shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I."

1. General Transportation Requirements:

• Devices must be transported and stored in accordance with manufacturer's specified conditions
• Manufacturer must define and validate storage/transport conditions in Technical Documentation
• Packaging must be validated for transport conditions (distribution simulation per ASTM D4169 or ISTA)

1. Temperature-Sensitive Devices (Cold Chain):

• Manufacturer defines temperature range (e.g., 2–8°C for biological components, 15–25°C ambient)
• Importers and distributors must maintain cold chain throughout distribution
• Temperature monitoring: calibrated data loggers required for cold-chain devices
• Swiss GDP equivalent: Switzerland follows EU GDP Guidelines (Good Distribution Practice) by reference — no separate Swiss GDP ordinance for medical devices, but HMG Art. 29 mandates GMP/GDP-equivalent standards

1. Sterile Devices:

• Sterile barrier system must remain intact throughout transport
• Distribution simulation testing (ASTM D4169, ISTA 2A/3A) required in Technical Documentation
• Special handling instructions for devices with fragile sterile barriers

1. Dangerous Goods in Transport:

• Devices containing: lithium batteries (IATA DGR), radioactive components (IAEA transport regulations), biological substances (ADR PI650 for Category B), cryogenic liquids
• Must comply with ADR (road — Swiss law via Chemikaliengesetz and SDR-Ordinance), RID (rail), IATA DGR (air)
• Swiss SDR (Ordonnance relative au transport de marchandises dangereuses par route, SR 741.621): implements ADR in Switzerland

1. Labeling of Storage/Handling Conditions:

• ISO 15223-1 symbols for: temperature limits (storage and transport thermometer symbols), humidity range, fragile, keep dry, keep away from sunlight
• Specific temperature symbols: snowflake (max -18°C), thermometer (temp range)
• Must appear on label per MepV Annex I §23.2(k)

1. Healthcare Institution Requirements:

• Hospitals and pharmacies receiving medical devices must store per manufacturer specifications
• Cantonal pharmacy laws and hospital regulations supplement MepV requirements

1. Define storage and transport conditions in product design phase

1. Validate packaging for defined transport conditions (distribution simulation study)

1. Specify conditions on label and in IFU (ISO 15223-1 symbols)

1. Include transport/storage validation data in Technical Documentation

1. Importers: verify storage infrastructure meets device requirements before import

1. Distributors: maintain temperature logs for cold-chain devices

1. For air transport of dangerous goods: complete shipper's declaration, apply IATA DGR labels

• Distribution simulation test report (ASTM D4169 or ISTA protocol)
• Packaging validation report including transport conditions
• Cold-chain management procedures (for temperature-sensitive devices)
• Temperature excursion management procedures
• Dangerous goods documentation (where applicable)

• Switzerland is a landlocked country — all international transport is via land (ADR) or air (IATA DGR); no sea freight standards required
• Temperature mapping studies for warehouses are not legally mandated but are industry best practice and expected by Swissmedic during inspections
• For devices transported through Switzerland in transit to EU/other markets: Swiss dangerous goods rules (SDR/ADR) apply to transit
• No separate Swiss GDP ordinance for medical devices — manufacturers and distributors should follow EU GDP Guidelines 2013/C 68/01 as best practice, as Swissmedic references these in inspections

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Definition (Verbatim Legal Text)

Art. 1 VREG (SR 814.620) — Scope:

"This Ordinance regulates the return, take-back and disposal of electrical and electronic equipment. It shall ensure that such equipment is taken back from users free of charge and disposed of in an environmentally sound manner."

Art. 3 para. 1 VREG — Take-back obligation:

"Manufacturers and importers of electrical and electronic equipment shall ensure take-back of such equipment from users free of charge."

Art. 1 VeVA (SR 814.610) — Purpose:

"This Ordinance lays down rules for the identification, characterisation, oversight and movement of special waste with a view to ensuring its proper and safe disposal."

Art. 30c USG (SR 814.01) — Extended Producer Responsibility:

"The Federal Council may require producers and importers of products to take back products or product components at the end of their useful life and to ensure their proper disposal. It may regulate the means by which they may discharge their obligations."

1. VREG (WEEE equivalent — for electrical medical devices):

• Category 8 (Medical devices) and Category 9 (Monitoring and control instruments) of VREG Annex 1
• Take-back obligation: Manufacturers/importers must take back EEE medical devices at end of life, free of charge from users/hospitals
• Producer registration: Must be registered with a collective take-back scheme (SENS eRecycling, SWICO, or direct system)
• Collection targets: Minimum collection/recycling rates per Annex 4 VREG
• Prepaid disposal fee (VEG — Vorgezogene Entsorgungsgebühr): Applied to new EEE devices at point of first placing on Swiss market — used to fund collection system
• Recycling targets: By material type — metal, plastics, glass components

1. VeVA (Special Waste — for medical device waste from healthcare settings):

• Contaminated single-use devices (biological contamination): classified as special waste (Sonderabfall)
• Sharps, used cannulas, blood-contacting devices: must follow VeVA procedures
• Movement of special waste requires VeVA permit (Begleitschein — movement document)
• Healthcare facilities must contract with licensed special waste disposal companies
• Incineration at approved medical waste incinerators (high-temperature)
• Swissmedic guidance on decontamination of returned medical devices before disposal

1. Hazardous Materials in Devices:

• Devices containing radioactive materials: additional obligations under Strahlenschutzgesetz (SR 814.50) — disposal via licensed radioactive waste managers
• Mercury-containing devices: ChemRRV obligations — collection and disposal via BAFU-authorized facilities
• Battery-containing devices: BattV take-back requirements (see Tile 4)

1. Extended Producer Responsibility (EPR) Scheme:

• Switzerland operates a voluntary EPR model for WEEE, enforced via VREG
• Two main collective schemes: SENS eRecycling (primarily consumer EEE) and SWICO Recycling (IT/AV equipment)
• Medical device manufacturers should join SENS or establish their own approved individual take-back system

1. Reporting:

• Annual reporting to BAFU (FOEN) on quantities placed on market vs. collected/recycled
• VeVA movement documents must be retained for minimum 5 years

1. Determine device category under VREG Annex 1 (is it EEE?)

1. Register with collective take-back scheme (SENS or SWICO) or establish own system — approved by BAFU

1. Pay VEG (prepaid disposal fee) on first import/sale into Switzerland

1. Ensure take-back infrastructure: customers/hospitals informed of free take-back right

1. For special waste (VeVA): identify waste classification; contract with licensed disposal company; issue VeVA movement documents for each shipment

1. Report annually on EEE collected and recycled volumes

1. For radioactive device components: contract with PSI or other licensed radioactive waste facility

• SENS/SWICO membership certificate
• VEG registration and payment records
• VeVA Begleitschein (special waste movement documents)
• Annual waste reporting to BAFU
• Disposal certificates from licensed waste managers

• Switzerland's VREG broadly mirrors EU WEEE Directive 2012/19/EU but has Swiss-specific implementation details
• Active implantable medical devices returned from patients post-explantation: governed by VeVA as potential special waste plus MepV Art. 11 (post-market surveillance) — manufacturer must have procedure for returned/explanted devices
• The SENS eRecycling scheme (www.sens.ch) is the primary organization for medical device EEE recycling — membership fees based on quantities placed on market
• Manufacturers outside Switzerland: the CH-AR or importer takes on producer responsibility obligations under VREG — this is a commonly overlooked CH-AR obligation
• Cybersecurity data destruction for devices with patient data storage: no specific Swiss ordinance, but data protection (DSG, SR 235.1) requires certified data destruction before device disposal

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Definition (Verbatim Legal Text)

Swissmedic Guidance — Artificial Intelligence in Medical Devices (2021 Position Paper):

"Artificial intelligence (AI) and machine learning (ML) are increasingly being used in medical devices. As a form of software-based medical device or as a component thereof, AI/ML is subject to the Medical Devices Ordinance (MepV, SR 812.213) if it meets the definition of a medical device."

MepV Art. 3 para. 1(a) — Definition of Medical Device (referencing EU MDR Art. 2(1)):

"'Medical device' means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease [...]"

MepV Art. 3 para. 1 — SaMD definition (via EU MDR Art. 2(1)):

"Software intended to be used for one or more of the specific medical purposes listed in the definition of a medical device is itself a medical device. Software which is an accessory to a physical medical device is governed by the same rules as the device of which it is an accessory."

1. Regulatory Framework for AI Medical Devices:

• AI/ML medical devices in Switzerland are regulated under MepV (SR 812.213) as Software as Medical Device (SaMD)
• No separate Swiss AI Act or AI-specific medical device regulation exists as of 2024
• Switzerland is not an EU member and is therefore not subject to the EU AI Act (2024/1689) — but Swissmedic monitors EU AI Act developments closely
• Swiss Federal Council has indicated intent to assess whether Swiss AI regulation is needed; as of 2024, no binding AI Act equivalent exists in Switzerland

1. Classification of AI Medical Devices:

• AI SaMD classified per EU MDR Annex VIII Rule 11 (software rule):
• Class I: software intended to provide information for non-diagnosis/non-treatment decisions
• Class IIa: software intended to provide information to take decisions for diagnosis or treatment of serious conditions
• Class IIb: software intended to provide information to take decisions for life-threatening diseases, or to monitor physiological processes in ICU
• Class III: software to control/influence life-supporting or life-sustaining devices, implantable devices
• IMDRF SaMD Framework (N10, N41, N56) used as supplementary guidance by Swissmedic

1. Key Technical Requirements for AI Medical Devices:

• Clinical Evaluation (MepV Annex XIV equivalent): Must include algorithm performance evidence using relevant datasets
• Software Lifecycle (IEC 62304): Full compliance required for AI/ML software classification (Class A, B, C per IEC 62304)
• Risk Management (ISO 14971): Must address AI-specific risks: bias, dataset representativeness, distributional shift, overfitting, explainability
• Transparency: Intended algorithm purpose, training data description, performance metrics, limitations must be documented in Technical Documentation
• Validation/Verification: AI model training/test/validation split must be documented; independent validation dataset required for Class IIb/III
• Post-market surveillance: Continuous performance monitoring required — AI-specific PMCF (Post-Market Clinical Follow-up) for learning/adaptive algorithms

1. Adaptive/Continuously Learning AI:

• If AI/ML algorithm updates autonomously without manufacturer intervention: each significant algorithmic change considered a device change (Art. 19 MepV notification may apply)
• Predetermined Change Control Plan (PCCP) concept: Swissmedic aligns with FDA/IMDRF guidance — manufacturers should pre-define the scope of algorithm changes that don't require new conformity assessment

1. Cybersecurity:

• MepV Annex I §17 (cybersecurity requirements): AI medical devices must address cybersecurity throughout lifecycle
• MDCG 2019-16 guidance on cybersecurity (applicable by reference in Swiss practice)
• ISO/IEC 27001 and IEC 81001-5-1 referenced for cybersecurity risk management

1. Swiss AI Policy Context:

• Swiss Federal Council published "Strategy on Artificial Intelligence" (2020) — not legally binding for medical devices
• FDHA (Federal Department of Home Affairs) — oversees digital health strategy which touches AI in healthcare
• Switzerland participates in IMDRF AI working group and Global Harmonization Task Force (GHTF) discussions
• Swissmedic has published position papers and participates in IMDRF SaMD discussions

1. Determine if AI/ML software meets medical device definition (MepV Art. 3)

1. Classify using EU MDR Annex VIII Rule 11 (software classification rule)

1. Apply IMDRF SaMD N10 severity framework as supplementary tool

1. Develop Technical Documentation including:

• Algorithm description (architecture, training methodology)
• Dataset description (provenance, representativeness, privacy compliance)
• Clinical validation data and performance metrics
• Limitations and failure mode analysis

1. Validate software per IEC 62304 (software lifecycle)

1. Conduct clinical evaluation per MepV Annex XIV / EU MDR Annex XIV

1. Establish Post-Market Surveillance plan with AI performance monitoring

1. Define Predetermined Change Control Plan (PCCP) if adaptive algorithm

1. Complete conformity assessment with Swissmedic-designated CAB or EU MDR NB

1. Notify Swissmedic if Class III or Class IIb active device

1. Submit to Swissmedic via eGov Portal

• Software Description Document (SaMD architecture, algorithm description)
• Dataset description and provenance documentation
• IEC 62304 Software Development Lifecycle documentation
• Clinical validation report (AI performance evidence)
• Risk Management File (ISO 14971, AI-specific risk analysis)
• Cybersecurity assessment (MDCG 2019-16 or IEC 81001-5-1)
• Predetermined Change Control Plan (for adaptive algorithms)
• Post-Market Performance Follow-up (PMPF) plan

• Switzerland ≠ EU AI Act: The EU AI Act (Regulation 2024/1689) classifies high-risk AI systems including medical devices — Swiss manufacturers targeting EU market must comply with EU AI Act; this does NOT automatically apply in Switzerland
• Swissmedic is actively monitoring EU AI Act implementation and may issue guidance on Swiss alignment — manufacturers should track Swissmedic announcements
• Patient Data and AI: Switzerland's new Federal Act on Data Protection (nDSG / DSG, SR 235.1, in force Sep 2023) governs use of patient data in AI training — requires legal basis for processing sensitive health data; data protection impact assessment (DPIA) required
• Real-world data / real-world evidence: Swissmedic accepts real-world evidence for clinical evaluation of AI devices, consistent with IMDRF SaMD N41 framework
• No separate Swiss AI medical device guidance document has been published as of 2024 — manufacturers should follow EU guidance (MDCG guidance documents, IMDRF SaMD documents) which are referenced by Swissmedic in its supervisory activities

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## Summary Reference Table

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*Report compiled by RegDesk DataManager | Sources: MepV SR 812.213, Swissmedic official guidance, BAFU/FOEN guidance, Swiss Federal Law Portal (fedlex.admin.ch) | Date: 2026-07-09*