Products without Intended Medical Purpose – Swissmedic Borderline Guidance

Legal Definition and Scope

Under the Swiss Therapeutic Products Act (TPA) and Medical Devices Ordinance (MedDO), a product qualifies as a medical device only if it has a specific intended medical purpose, such as diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, or disability. Products lacking this explicit medical intention are excluded from the medical device regulatory framework, regardless of their physical similarity to regulated devices or potential health effects. This borderline guidance clarifies the distinction to prevent misclassification. Welche Produkte ohne Medizinzweckbestimmung - Swissmedic

Key Criteria for Exclusion

A product falls outside medical device regulation if:

• No medical purpose is stated or implied in labelling, instructions for use, advertising, or other materials.
• The manufacturer does not claim any diagnostic, therapeutic, or preventive effect on the human body.
• The intended use is purely cosmetic, lifestyle, wellness, or general well-being related (e.g., beauty enhancement, fitness tracking without medical claims, aromatherapy).
• Any health-related statements are general and not linked to specific medical conditions or outcomes.

Examples of Non-Medical Device Products

Swissmedic lists typical categories and examples that are generally not considered medical devices:

• Cosmetic products – creams for skin moisturising or anti-ageing without medical claims.
• Lifestyle and wellness devices – fitness trackers, massage devices, or light therapy lamps promoted for relaxation or general vitality.
• Aesthetic devices – non-invasive body contouring equipment marketed solely for appearance improvement.
• General hygiene or household items – air purifiers or water filters without specific therapeutic claims.
• Products with alternative claims – magnetic bracelets or bioresonance devices advertised for "energy balancing" without medical indication.

If a manufacturer later adds medical claims (e.g., "treats acne" or "reduces chronic pain"), the product may become subject to medical device requirements.

Borderline Cases and Assessment

Some products sit on the border between medical and non-medical use. Swissmedic evaluates on a case-by-case basis, considering:

• Explicit wording in intended purpose statements.
• Overall presentation and marketing materials.
• Mode of action (whether it primarily achieves its effect through pharmacological, immunological, or metabolic means – which may shift classification to other product categories).

Manufacturers are advised to consult Swissmedic in advance for borderline products to avoid misclassification risks.

Regulatory Implications

Products without medical purpose are not subject to MedDO requirements (conformity assessment, CE marking equivalence, vigilance, etc.) but may fall under other regulations, such as:

• Cosmetics legislation.
• General product safety rules.
• Chemical or biocidal product laws.
• Consumer protection provisions.

Incorrect classification as a non-medical product while making medical claims can lead to enforcement actions, including market withdrawal.

This guidance supports consistent application of the medical device definition in Switzerland, ensuring only products with genuine medical intent are regulated accordingly. Detailed examples, decision trees, and contact information for clarification are provided on the Swissmedic page dedicated to products without intended medical purpose. Welche Produkte ohne Medizinzweckbestimmung - Swissmedic