Swissmedic has updated its information sheet “Products without an intended medical purpose”, identified as MU600_00_007.
Version 1.5 is valid from 12 August 2026 and includes updates to examples of products, transitional provisions and common specifications.
The guidance is intended to help manufacturers, importers, authorised representatives and users understand the Swiss regulatory requirements applicable to products without an intended medical purpose.
What Are Products Without an Intended Medical Purpose?
Under Annex 1 of the Medical Devices Ordinance (MedDO), these are products that do not have a medical purpose but may present risks to people comparable to those associated with medical devices.
For this reason, they are subject to essentially the same general safety and performance requirements as medical devices.
Swissmedic identifies six product groups covered by Annex 1 MedDO:
contact lenses and other items introduced into or onto the eye;
surgically invasive products intended to modify anatomy or fix body parts, excluding tattoos and piercings;
substances or items used for facial, dermal or mucous membrane filling;
equipment used to reduce, remove or destroy adipose tissue;
high-intensity electromagnetic radiation equipment used for skin resurfacing, tattoo or hair removal and similar treatments;
equipment intended for brain stimulation using electrical, magnetic or electromagnetic fields.
Why These Products Are Regulated
Swissmedic explains that Annex 1 products may pose significant health risks to consumers, self-users and professional users.
Stricter regulation is therefore intended to ensure that manufacturing, quality and surveillance requirements are aligned with those applied to devices with an intended medical purpose.
This is particularly relevant where products may be used directly by non-professional users at home.
Swiss Regulatory Framework
Products without an intended medical purpose have been subject to the Swiss Medical Devices Ordinance since 26 May 2021.
Following the adoption of EU Implementing Regulations 2022/2346 and 2022/2347, Switzerland incorporated equivalent common specifications and classification requirements into MedDO. The revised requirements became applicable on 1 November 2023.
Two Routes for Market Availability
Since 1 November 2023, Swissmedic identifies two possible routes for products falling under Annex 1 MedDO.
Under the first route, products comply with the new framework, including common specifications and all applicable MedDO requirements. Swissmedic is then responsible for market surveillance.
Under the second route, eligible products may continue to be placed on the market or put into service under previous sector-specific legislation during applicable transitional periods.
Transitional Provisions
To benefit from the transitional provisions, a product must:
have been legally marketed in Switzerland before 1 May 2024;
continue to comply with applicable legislation;
not have undergone a substantial change.
Manufacturers must also demonstrate compliance with general safety and performance requirements, including through clinical evaluation where applicable.
Clinical data may include post-market surveillance, post-market clinical follow-up and, where relevant, specific clinical investigations.
Transitional Deadline With a Clinical Investigation
Where a manufacturer plans a clinical investigation to obtain data for clinical evaluation, eligible products may continue to be placed on the market or put into service under the previous framework until 31 December 2029, provided specified conditions are met.
These include:
confirmation from the responsible authority before 1 November 2024 that the clinical study application was complete and within MedDO;
initiation of the clinical investigation before 2 May 2025;
a written conformity assessment agreement with a designated body from 1 January 2028.
Transitional Deadline Without a Clinical Investigation
Where no clinical investigation is planned, eligible products may continue under the previous legislation until 31 December 2028.
From 1 January 2027, the manufacturer must have a written agreement with a designated body for the conformity assessment.
Once the transitional deadlines expire, or where the applicable conditions are no longer met, the product may only be marketed if it has successfully completed conformity assessment under MedDO and carries the appropriate conformity marking.
The flowchart on page 8 of the Swissmedic information sheet provides a visual overview of the transitional decision process and the applicable 2028 and 2029 deadlines.
Conformity Assessment and CE Marking
Manufacturers of Annex 1 products must conduct a conformity assessment involving a designated body.
After successful completion, the manufacturer may issue a declaration of conformity and apply the applicable CE mark.
Swissmedic notes that all Annex 1 products fall within risk classes IIa, IIb or III, meaning involvement of a designated body is required once transitional provisions no longer apply.
Marketing Products Under an Own Name or Brand
A distributor or importer that makes an Annex 1 product available under its own name, trade name or trademark assumes the obligations of the manufacturer.
An exception applies where an agreement with the original manufacturer exists and the manufacturer remains identified as such on the labelling and retains responsibility for manufacturer obligations.
This is particularly relevant for private-label and rebranded aesthetic products.
Obligations for Importers and Distributors
Importers and distributors may only place or make products available on the Swiss market if they comply with MedDO.
For products already assessed under the EU MDR framework, conformity can be demonstrated through the relevant declaration and certificate of conformity.
Where a product remains on the market under transitional provisions, economic operators must instead verify that the manufacturer continues to satisfy the applicable transitional conditions.
Mandatory Swissmedic Registration
A key requirement highlighted in the updated guidance concerns product registration.
Since 1 July 2026, Annex 1 products marketed under the new legislation must be registered with Swissmedic in the same manner as devices with an intended medical purpose.
Registration must be completed by 31 December 2026.
This is an important near-term compliance deadline for manufacturers and Swiss economic operators.
Swiss Authorised Representative
Manufacturers established outside Switzerland that place Annex 1 products on the market under MedDO must appoint a Swiss authorised representative, or CH-REP, in writing.
Products marketed solely under applicable transitional provisions do not require a Swiss authorised representative for that transitional route.
Product Information and Language Requirements
Product information includes the labelling and instructions for use.
Where a product is intended for the general public, information must normally be provided in all three official Swiss languages:
German;
French;
Italian.
Fewer languages or English may be acceptable in certain professional-use circumstances, provided the specified safety and comprehension conditions are met.
Incident Reporting
Professionals using these products have a legal obligation to report serious incidents to Swissmedic through materiovigilance.
Swissmedic notes that this includes quality defects or malfunctions that actually or potentially jeopardise consumer or user safety, even where no actual injury ultimately occurs.
Customers and self-users may also report non-conformities or serious incidents to the competent authority.
Existing Products in Healthcare Institutions
The FAQ section clarifies that devices already placed on the market, put into service and in use before 1 November 2023may continue to be used until the end of their lifecycle, provided their conformity and safety are not called into question by the manufacturer.
Swissmedic also clarifies that the expiry of a conformity certificate should not automatically be interpreted as the end of a product’s service life.
Facilities remain responsible for appropriate maintenance to ensure continued safety.
CE Marking Must Be Verified Carefully
Swissmedic warns that the presence of a CE mark alone is not sufficient to demonstrate compliance.
CE marks can be issued under different EU legal frameworks. For products under Annex 1 MedDO, the relevant legal basis must also be verified through the declaration of conformity.
This means CE marking under legislation such as the Low Voltage Directive or Electromagnetic Compatibility Directive does not by itself establish conformity with the medical device framework.
Formal Requirements for Conforming Products
Annex 1 of the information sheet summarises the formal elements that should be checked for conforming devices.
These include:
CE or MD conformity marking;
identification of the manufacturer;
CH-REP details for manufacturers outside Switzerland;
Swiss importer information;
declaration of conformity;
valid conformity certificate where applicable.
The table on page 15 provides a practical visual checklist for verifying these elements on products and accompanying documentation.
Impact on Manufacturers and Economic Operators
For manufacturers, importers, distributors, authorised representatives and professional users of aesthetic and other non-medical-purpose products in Switzerland, the updated information sheet highlights several important compliance priorities.
Stakeholders should pay particular attention to:
whether the product falls under Annex 1 MedDO;
applicable transitional deadlines;
clinical evaluation requirements;
conformity assessment agreements with designated bodies;
CE marking and declaration of conformity;
Swissmedic registration by 31 December 2026;
CH-REP obligations;
importer and distributor verification duties;
product information language requirements;
vigilance and serious incident reporting;
private-label and own-brand responsibilities.
The key message is that products without an intended medical purpose are increasingly regulated in Switzerland in the same way as medical devices, with equivalent expectations around safety, conformity assessment, economic operator oversight and post-market surveillance.
