Research on defined product requirements and the use of standards in Switzerland. Each record identifies its scope, source and practical evidence questions.
Market scope
Swiss sector law and EU law are not interchangeable; mutual recognition needs an instrument.
The records below examine specific provisions and standards relationships. They do not combine different products or regulatory roles into one approval route.
Apply the Swiss subsidiary product-safety requirements
Federal Act on Product Safety (PrSG), SR 930.11 · Article 3(1)-(4), (6)
Products may be placed only with no or minimal health and safety risk under normal or reasonably foreseeable use. The rule addresses relevant users, product interaction, lifetime and safety information. Applicable essential requirements take priority; where none are set, the state of knowledge and technology supplies the benchmark.
Scope, actions and official sources
Issuer
Swiss Confederation
Status and context
In force for the stated scope
Edition or text examined
Consolidation 2023-09-01; latest applicable consolidation identified in official RDF
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Manufacturers and subsidiary responsible importers, traders or service providers within the Act’s scope.
Scope and conditions
Sector law takes precedence for the safety risks it regulates under Article 1(3).,The Act’s exclusions and product definitions remain applicable.
Actions
Determine the product and sector-law boundary.
Assess foreseeable use and vulnerable users.
Align warnings, presentation and instructions with the product’s hazards.
Evidence identified by the source
Compliance with the applicable safety benchmark.
Materials for the research review
Product-risk and sector-law assessment.
Safety information matched to the foreseeable use.
Dates and application
Source Version
Consolidation 2023-09-01; latest applicable consolidation identified in official RDF
Keep an up-to-date low-voltage declaration of conformity
Ordinance on Low-Voltage Electrical Equipment (NEV), SR 734.26 · Article 8(1)-(5)
The operator must be able to produce a declaration demonstrating essential-requirement conformity. It must use a Swiss official language or English, identify the equipment and responsible persons and state the applied technical references and their editions. Where multiple rules require declarations, the provision calls for a single declaration with the relevant information.
Scope, actions and official sources
Issuer
Swiss Confederation
Status and context
In force for the stated scope
Edition or text examined
Consolidation 2023-01-01; official RDF version identity checked
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Economic operators making covered low-voltage equipment available, with the stated conditional fulfilment-provider arrangement.
Scope and conditions
Product categories and conditions in Article 1 govern scope.,The declaration does not replace all technical or information obligations.
Actions
Identify the covered equipment and responsible operator.
Prepare the declaration with the specified identifiers and editions.
Keep it current as applicable information changes.
Evidence identified by the source
Declaration of conformity with Article 8 particulars.
Materials for the research review
Model identity and signed declaration.
Consistency with the applied technical assessment.
Dates and application
Source Version
Consolidation 2023-01-01; official RDF version identity checked
Prepare the Swiss EMC declaration under the applicable ordinance
Ordinance on Electromagnetic Compatibility (VEMV), SR 734.5 · Article 11(1)-(3)
The declaration confirms that fulfilment of the essential requirements has been demonstrated and must remain up to date. It must follow the prescribed model and use a Swiss official language or English. A combined declaration, or equivalent dossier of individual declarations, addresses apparatus governed by several declaration rules.
Scope, actions and official sources
Issuer
Swiss Confederation
Status and context
In force for the stated scope
Edition or text examined
Consolidation 2022-01-01; official RDF version identity checked
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Manufacturers or authorized persons issuing declarations for covered EMC apparatus.
Scope and conditions
Radio-equipment and other scope exclusions require separate assessment.,A CE-marked declaration must follow the applicable alternative form described by BAKOM.
Actions
Check the apparatus and applicable EMC route.
Use the prescribed declaration model.
Maintain the declaration and applicable language.
Evidence identified by the source
Declaration of conformity meeting Article 11.
Materials for the research review
Apparatus scope and the appropriate declaration form.
Coordination with other declaration regimes.
Dates and application
Source Version
Consolidation 2022-01-01; official RDF version identity checked
Appoint a Swiss device representative through a written mandate
Medical Devices Ordinance (MepV/MedDO), SR 812.213 · Article 51(1)-(3bis)
An overseas manufacturer must designate a representative domiciled in Switzerland through a written mandate. The representative handles formal and safety-related market-placement matters. The ordinance specifies the mandate framework and an alternative arrangement for supplying technical documentation directly to Swissmedic, with the stated response condition.
Scope, actions and official sources
Issuer
Swiss Confederation
Status and context
In force for the stated scope
Edition or text examined
Consolidation 2026-07-01; official RDF version identity checked
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Manufacturers domiciled outside Switzerland placing covered devices on the Swiss market.
Scope and conditions
Device-specific scope, transitional or special arrangements require separate assessment.,An EU representative is not automatically the Swiss representative.
Actions
Determine the Swiss representative requirement.
Put the written mandate and responsibilities in place.
Ensure technical documentation can be supplied through the permitted arrangement.
Evidence identified by the source
Written mandate.
Documentation-access arrangement satisfying the ordinance where that option is used.
Materials for the research review
Manufacturer and representative identity.
Coverage of the actual devices and Swiss responsibilities.
Dates and application
Source Version
Consolidation 2026-07-01; official RDF version identity checked
Complete chemical self-control before first Swiss supply or own use
Chemicals Ordinance (ChemV), SR 813.11 · Article 5(1), (4)-(5)
The manufacturer must assess possible human-health or environmental harm using accessible relevant data. Classification, packaging, labeling and applicable documentation are governed by the ordinance. A professional or commercial importer must fulfil the relevant self-control duties before first supply to others, or before first use for own use.
Scope, actions and official sources
Issuer
Swiss Confederation
Status and context
In force for the stated scope
Edition or text examined
Consolidation 2026-04-24; official RDF version identity checked
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Responsible manufacturers and commercial/professional importers of substances, preparations and relevant articles.
Scope and conditions
Separate authorizations, notifications and product-specific restrictions may apply.,Classification, packaging and documentation duties follow their applicable detailed conditions.
Actions
Identify the Swiss responsible manufacturer/importer.
Collect the relevant hazard and composition data.
Complete the applicable controls before the first supply or own use.
Evidence identified by the source
Applicable classification, packaging, labeling and prescribed chemical information.
Materials for the research review
Evidence supporting the hazard assessment.
Separate authorization and notification screening.
Dates and application
Source Version
Consolidation 2026-04-24; official RDF version identity checked
Foodstuffs and Utility Articles Ordinance (LGV), SR 817.02 · Article 44(1), (3)
At the offer stage, the required information must appear on the selling medium or be available through another clearly identified free method, with the stated date and lot exceptions. All required information must be available at delivery. Swiss category and language provisions remain relevant to deciding the information content.
Scope, actions and official sources
Issuer
Swiss Confederation
Status and context
In force for the stated scope
Edition or text examined
Consolidation 2025-07-01; official RDF version identity checked
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Prepacked foods offered using distance-communication techniques.
Scope and conditions
Shelf-life date and lot identification are excluded from the offer-stage rule but required at delivery.,Vending-machine sales have the paragraph (3) exception.
Actions
Determine the applicable Swiss food particulars.
Provide the offer-stage information through a free identified method.
Check all required information at delivery.
Evidence identified by the source
Required food information at the stages specified in Article 44.
Materials for the research review
Offer mapped to the actual food.
Product-specific and language requirements.
Dates and application
Source Version
Consolidation 2025-07-01; official RDF version identity checked
These records distinguish adoption, legal incorporation, designation and programme recognition. A standard’s use is assessed within the specific relationship recorded.
Standards relationship · SWITZERLAND-R01
Testing laboratories use the SAS ISO/IEC 17025 assessment framework
SAS testing-laboratory reference document 302 · Programme reference identity and scope
SAS publishes a dedicated testing-laboratory assessment reference tied to ISO/IEC 17025:2017. Its role is to assess laboratory competence within the accreditation programme. A customer still needs to match the particular testing activity to the current scope and determine whether the receiving regulator recognizes that evidence.
Scope, actions and official sources
Issuer
Swiss Accreditation Service (SAS)
Status and context
Published SAS programme reference for the stated edition; individual accreditation and transition arrangements control use
SAS identifies ISO/IEC 17020 for inspection-body assessment
SAS inspection-body reference document 602 · Programme reference identity and scope
The SAS inspection document explicitly identifies ISO/IEC 17020:2012 as its assessment basis. This is a programme-use relationship, distinct from a technical product standard. For a specific inspection, the body’s current accredited activities and any legally required designation must be verified separately.
Scope, actions and official sources
Issuer
Swiss Accreditation Service (SAS)
Status and context
Published SAS programme reference for the stated edition; individual accreditation and transition arrangements control use
Inspection bodies assessed under the published SAS inspection programme reference.
Scope and conditions
A published reference does not establish the scope of an individual body.,Any edition transition must be handled under the programme’s applicable arrangements.
Actions
Identify the inspection activity and body.
Check the current scope and programme edition arrangements.
Confirm any separate legal designation required.
Materials for the research review
Inspection scope and independence type.
Applicable programme transition and regulator designation.
SAS uses ISO/IEC 17065 for product-certification-body accreditation
SAS product-certification reference document 502 · Programme reference identity and scope
The official SAS reference document identifies ISO/IEC 17065:2012 for assessment of product, process and service certification bodies. This establishes a competence-framework relationship. Users must still examine the body’s scope and the scheme behind an individual certificate, including the actual product and normative references covered.
Scope, actions and official sources
Issuer
Swiss Accreditation Service (SAS)
Status and context
Published SAS programme reference for the stated edition; individual accreditation and transition arrangements control use
Bodies certifying products, processes or services under the SAS programme.
Scope and conditions
Accreditation of a certification body is not a certificate for a particular product.,The particular certification scheme and scope control what the body can certify.
Actions
Identify the certificate and certification scheme.
Check the body’s current accredited scope.
Match the product and standard to the actual certificate.
SAS’s medical-laboratory route uses ISO 15189:2022
SAS medical-laboratory accreditation transition rules · Programme reference identity and scope
The SAS transition rules identify ISO 15189:2022 for medical-laboratory accreditation and set 5 December 2025 as the last validity day under the previous 2012 edition. Its 2026 programme page lists the 2022 assessment framework. A current claim must therefore be checked against the actual accreditation, not an old 2012 certificate.
Scope, actions and official sources
Issuer
Swiss Accreditation Service (SAS)
Status and context
Published SAS programme reference for the stated edition; individual accreditation and transition arrangements control use
Edition or text examined
ISO 15189:2022; programme transition from ISO 15189:2012
Relationship
Programme use or recognition
Legal character
Recognised for the stated purpose
Source check
2026-10-20
Applies to
Medical laboratories within the SAS medical-testing accreditation programme.
Scope and conditions
Non-patient-related testing is not automatically within the medical-laboratory route.,A laboratory accreditation is not device regulatory approval.
Actions
Check the laboratory’s actual current accreditation.
Use the correct patient-related programme scope.
Distinguish medical testing from other laboratory activities.
Materials for the research review
Current medical-laboratory scope.
Completion of the applicable edition transition.
Dates and application
Source Version
ISO 15189:2022; programme transition from ISO 15189:2012
The linked official sources establish the provisions, document identities or relationships examined. NCQM supplies original English analysis. Where an official source is in another language, the English explanation is not an official translation. Source-check dates, effective dates and adopted editions are kept separate.
The research review materials help organize an assessment. They are distinguished from evidence expressly identified by the source. International standards remain subject to their publishers’ access and rights conditions.
