Swissmedic has published Version 1.6 of its Information Sheet “Products without an intended medical purpose”, valid from 14 October 2026.
The guidance explains how products listed under Annex 1 of the Swiss Medical Devices Ordinance (MedDO) are regulated and provides practical information for manufacturers, importers, authorised representatives, distributors and users. 1793080747375 1793080747375
What Are Products Without an Intended Medical Purpose?
Annex 1 MedDO covers products that do not have a medical intended purpose but present risks comparable to those of medical devices.
Swissmedic therefore requires these products to meet essentially the same general safety and performance requirements as medical devices. 1793080747375
The six product groups include:
contact lenses and other items introduced into or onto the eye;
surgically invasive products intended to modify anatomy or fix body parts;
dermal and mucous membrane fillers;
equipment for reducing, removing or destroying adipose tissue;
high-intensity electromagnetic radiation equipment, including lasers and intense pulsed light systems;
brain stimulation equipment using electrical, magnetic or electromagnetic fields. 1793080747375
Why These Products Are Regulated
Swissmedic explains that these products can create significant potential health risks for customers, self-users and professional users.
Stricter requirements for manufacturing, marketing and use are therefore intended to ensure that their manufacturing quality and surveillance reach a level comparable to medical devices with an intended medical purpose. 1793080747375
Regulatory Framework Since November 2023
The legal requirements changed on 1 November 2023, following the incorporation into Swiss law of provisions equivalent to EU Implementing Regulations 2022/2346 and 2022/2347. 1793080747375
Products placed on the market under the new framework must comply with the common specifications and applicable MedDO requirements.
Swissmedic also maintains transitional provisions allowing certain products to continue under earlier sector-specific legislation where the relevant conditions are met. 1793080747375
Transitional Provisions
To continue benefiting from the transitional framework, a product must have been legally marketed in Switzerland before 1 May 2024 and must not have undergone a substantial change. 1793080747375
Manufacturers must also demonstrate compliance with applicable general safety and performance requirements.
For these products, the clinical evaluation must be based on relevant data concerning performance and safety and may include information from:
post-market surveillance;
post-market clinical follow-up;
specific clinical investigations. 1793080747375
Deadlines for Products With Clinical Investigations
Where a manufacturer is conducting a clinical investigation to obtain data for the clinical evaluation, products may continue to be placed on the market or put into service under existing legislation until 31 December 2029, provided specific conditions are fulfilled. 1793080747375
These include:
confirmation 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. 1793080747375
Deadline Where No Clinical Investigation Is Planned
If no clinical investigation is planned, products may continue under the existing legislation until 31 December 2028, provided the applicable conditions are met.
From 1 January 2027, the manufacturer must have a written agreement with a designated body for the conformity assessment. 1793080747375
The flowchart on page 8 of the information sheet visually summarises these transitional pathways and key deadlines.
Conformity Assessment and CE Marking
Once the transitional provisions expire—or if a manufacturer no longer fulfils their conditions—the product may only be placed on the Swiss market if it has successfully completed the MedDO conformity assessment process and carries the appropriate conformity marking. 1793080747375
Manufacturers of Annex 1 products must involve a designated body in the conformity assessment.
After successful completion:
a declaration of conformity must be issued;
the product must carry the appropriate CE mark. 1793080747375
The annex on page 15 also shows that all Annex 1 products fall within risk classes IIa, IIb or III, meaning designated-body involvement is required. 1793080747375
Products Marketed Under an Own Name
Swissmedic also clarifies the responsibilities of companies placing Annex 1 products on the market under their own name, trading name or trademark.
Such companies generally assume the obligations of the manufacturer and must be able to demonstrate conformity.
An exception applies where an agreement with the original manufacturer ensures that the manufacturer remains identified as such on the labelling and retains responsibility for compliance. 1793080747375
Obligations for Importers and Distributors
Importers and distributors may only place or make available products that comply with MedDO. 1793080747375
For products assessed under the new legislation, conformity may be demonstrated through the declaration and certificate of conformity.
For products continuing under transitional provisions, economic operators must establish whether the manufacturer still satisfies the applicable transitional conditions. 1793080747375
Mandatory Swissmedic Registration
One of the most important operational points concerns registration.
Since 1 July 2026, Annex 1 products placed on the market under the new legislation must be registered with Swissmedic in the same way as medical devices with an intended medical purpose.
The registration must be completed by 31 December 2026. 1793080747375
This creates an immediate compliance deadline for manufacturers and economic operators with affected products on the Swiss market.
Swiss Authorised Representative
Manufacturers based outside Switzerland must appoint a Swiss authorised representative (CH-REP) when their Annex 1 products are placed on the market under MedDO and conformity has been demonstrated under EU MDR.
Products placed on the market solely under the transitional provisions do not require a Swiss authorised representative while those provisions continue to apply. 1793080747375 1793080747375
Product Information and Language Requirements
For products intended for the general public, labelling and instructions for use must normally be available in all three official Swiss languages:
German;
French;
Italian. 1793080747375
Fewer languages or English may be used in certain professional-use situations, provided the conditions specified by Swissmedic are met and safety is not compromised. 1793080747375
CE Marking Must Be Based on EU MDR
Swissmedic also warns that simply checking whether a product carries a CE mark is not sufficient.
For Annex 1 products, the relevant CE marking must be based on the EU MDR.
CE marking issued under other legislation, such as the Low Voltage Directive or EMC Directive, does not demonstrate conformity with the medical device requirements applicable to these products. 1793080747375
Vigilance and Incident Reporting
The guidance also confirms that professionals using these products have a legal obligation to report serious incidents to Swissmedic.
This includes defects or malfunctions that actually or potentially jeopardise the safety of users or consumers, even where no actual harm ultimately occurred. 1793080747375
Customers and self-users may also report non-conformities or serious incidents.
Formal Requirements for Conforming Products
The annex to the information sheet summarises the formal requirements applicable to products placed on the market under MedDO.
These include:
CE mark with notified body identification number;
manufacturer details;
CH-REP details for non-Swiss manufacturers;
Swiss importer details;
declaration of conformity;
valid certificate of conformity. 1793080747375
This checklist provides a useful practical reference for importers, distributors and regulatory teams assessing whether products are correctly documented.
Impact on Manufacturers and Economic Operators
For manufacturers, importers, distributors and authorised representatives, the updated guidance reinforces the need to actively manage the regulatory transition for Annex 1 products.
Key priorities include:
determining whether products remain eligible for transitional provisions;
monitoring the 2028 and 2029 deadlines;
ensuring a written agreement with a designated body is in place when required;
completing Swissmedic registration by 31 December 2026 where applicable;
verifying EU MDR-based CE marking;
appointing a CH-REP where required;
ensuring compliant labelling and instructions for use;
maintaining vigilance and incident-reporting processes.
The guidance makes clear that products without an intended medical purpose are increasingly being brought into a regulatory framework closely aligned with that applicable to traditional medical devices.
What Changed in Version 1.6?
According to the change history, Version 1.6 introduces changes to the annex of the information sheet. 1793080747375
The updated annex provides a structured overview of formal conformity requirements, including CE marking, notified body involvement, manufacturer and importer information, Swiss authorised representative details and conformity documentation.
