Swissmedic has published Version 8.0 of its information sheet on the obligations of economic operators in Switzerland, valid from 26 October 2026.
The document provides guidance on the responsibilities of Swiss authorised representatives, importers and distributors for medical devices and in vitro diagnostic medical devices placed on the Swiss market.
The latest revision specifically updates Chapter 5 to address the addition of importer information to product registrations.
Swiss Regulatory Framework
Switzerland’s current medical device framework is aligned closely with the EU MDR and IVDR.
Following the revision of the Swiss Medical Devices Ordinance and the introduction of the IVD Ordinance, Swiss requirements were designed to maintain comparable levels of quality, safety and performance to those applied in the EU.
However, because the Switzerland–EU Mutual Recognition Agreement was not updated in 2021, Switzerland introduced additional national measures.
These include:
appointment of a Swiss authorised representative;
registration of economic operators and products in swissdamed;
reporting of serious incidents to Swissmedic;
recognition of EU conformity certificates.
Who Is Considered an Economic Operator?
The guidance covers several actors within the medical device supply chain.
These include:
manufacturers;
Swiss authorised representatives (CH-REP);
importers;
distributors;
persons assembling systems and procedure packs.
Swissmedic also clarifies the different roles associated with placing devices on the Swiss market.
CH-REP Requirements
Manufacturers established outside Switzerland must generally appoint a Swiss authorised representative before their devices can be placed on the Swiss market.
This requirement also applies to manufacturers established in the EU or EEA.
The CH-REP acts on behalf of the foreign manufacturer for specified regulatory responsibilities under Swiss law.
Among its key responsibilities are:
maintaining access to technical documentation;
verifying conformity documentation;
cooperating with Swissmedic;
supporting vigilance;
maintaining the required registrations;
appointing a PRRC where required.
Importer Role
An importer is a natural or legal person established in Switzerland that places a product from another country on the Swiss market.
Unlike the CH-REP, an importer is not formally “appointed”. The role results directly from the company’s activity within the supply chain.
Importers must ensure that devices comply with applicable Swiss requirements before placement on the market.
Distributor Role
A distributor is an economic operator in the supply chain that makes a product available on the Swiss market, excluding the manufacturer and importer.
Distributors must exercise due diligence and perform formal checks before supplying devices.
Product and Economic Operator Registration
A major focus of the updated guidance is registration in swissdamed.
Both CH-REPs and importers must register as economic operators and obtain a Swiss Single Registration Number (CHRN).
Distributors do not have an equivalent registration obligation.
Product Registration in swissdamed
Swissmedic states that product registration in swissdamed became mandatory from 1 July 2026, with a transition period allowing registration to be completed by 31 December 2026.
From 1 January 2027, CH-REPs must ensure that devices are correctly registered in swissdamed.
Importers must also verify product registration before placing devices on the market.
New Importer Data Requirement
The key change in Version 8.0 concerns the inclusion of importer information within product registrations.
Swissmedic states that from 1 April 2027, importer data must be added to the relevant product registration in swissdamed.
The technical functionality allowing importers to be linked to devices has been available since 1 October 2026.
Swissmedic allows this linkage to be completed by 1 April 2027.
This is one of the most important operational changes introduced by Version 8.0.
Product Verification Obligations
Economic operators must perform checks before devices are placed or made available on the Swiss market.
Importers must formally verify compliance before placement on the market, while distributors must carry out equivalent checks before making devices available.
Where a non-conformity is identified, the relevant manufacturer, authorised representative and, where appropriate, importer must be informed.
PRRC Requirement for CH-REPs
Swiss authorised representatives must have a Person Responsible for Regulatory Compliance (PRRC) within their organisation.
This requirement does not apply to importers or distributors.
The PRRC therefore remains an important organisational requirement for CH-REPs operating in Switzerland.
Traceability Requirements
Economic operators must cooperate to ensure appropriate product traceability.
At Swissmedic’s request, they must be able to identify:
economic operators from whom devices were received;
economic operators to whom devices were supplied;
healthcare institutions;
healthcare professionals receiving devices.
These records must be retained for at least:
10 years for most devices;
15 years for implantable devices.
UDI for Class III Implants
Economic operators and healthcare institutions must record and store, preferably electronically, the UDI of Class III implants they receive or supply.
This requirement supports improved traceability and faster action in the event of safety issues or recalls.
Complaints and Suspected Incidents
Importers and distributors must maintain registers of:
complaints;
non-conforming products;
recalls;
withdrawals.
Complaints and reports of suspected incidents must also be forwarded promptly through the supply chain.
Vigilance Responsibilities
The CH-REP has responsibility for ensuring that serious incidents, field safety corrective actions and trend reports are submitted to Swissmedic where required.
Importers and distributors are not responsible for filing those reports directly, but they must forward complaints and suspected incidents to the relevant manufacturer and authorised representative.
Corrective Actions and Recalls
All economic operators must cooperate where corrective or preventive actions are required.
Importers and distributors must participate in implementation of corrective actions, including recalls, while CH-REPs must cooperate with Swissmedic.
Documentation Retention
CH-REPs and importers also have long-term documentation retention obligations.
CH-REPs must maintain access to technical documentation and conformity documentation for:
10 years after the last device was placed on the market;
15 years for implantable devices.
Importers must retain declarations and certificates for the same periods.
Manufacturer, CH-REP and Importer Identification
Swissmedic clarifies how economic operators must be identified on the device or accompanying documentation.
The manufacturer must always be clearly identified on the labelling.
For imported products, importer details may appear:
on the device;
on the packaging;
on an accompanying document.
CH-REP information must be provided according to the applicable device category and regulatory pathway.
Swiss Interpretation of Accompanying Documents
Swissmedic provides a practical interpretation of what constitutes a document accompanying the device.
Examples include:
delivery notes;
warranty documents;
customs documents;
invoices;
stickers on packaging or instructions for use.
Swissmedic notes that its interpretation differs from the European interpretation in MDCG 2021-27, partly for supply-related reasons.
Translation and Repackaging
Importers and distributors may translate product information or repackage products under certain conditions.
However, repackaged or relabelled products must be notified to Swissmedic before placement on the market.
The quality management system of the importer or distributor may also require assessment by a designated or notified body.
Legacy Devices
The guidance continues to address transitional arrangements for devices certified under:
MDD;
AIMDD;
IVDD.
Swissmedic stresses that economic operators cannot simply assume that expired certificates automatically qualify for extended validity.
CH-REPs and importers must perform a plausibility check of the evidence supporting transitional eligibility.
Evidence may include:
manufacturer declarations;
notified body confirmation letters;
documentation confirming conformity assessment applications and agreements.
Dual Roles Require Dual Obligations
A company can simultaneously act as both importer and CH-REP.
In this situation, it must comply with the obligations associated with both roles and register separately for each, receiving two different CHRNs.
This is important for companies operating integrated regulatory and distribution structures.
Address Changes
Swissmedic also provides practical guidance where a CH-REP or importer changes its address.
Although no formal transition period is defined in law, Swissmedic may tolerate use of the old address during a controlled transition period of up to six months, provided the process is justified, documented and properly managed.
Supply Chain Traceability Data
To comply with Swiss disclosure requirements, economic operators should record information including:
source of products;
recipients;
quantities;
lot numbers;
serial numbers;
delivery dates. 1793197351559
Records should be organised so that information can be provided to Swissmedic quickly when required.
Impact on Medical Device and IVD Companies
The update is particularly important for:
manufacturers outside Switzerland;
CH-REPs;
importers;
distributors;
regulatory and quality teams.
Priority actions include:
completing product registration in swissdamed by 31 December 2026;
preparing for importer linkage requirements by 1 April 2027;
confirming economic operator registrations and CHRNs;
reviewing product verification procedures;
maintaining traceability records;
updating complaint and vigilance procedures;
reviewing labelling and economic operator information;
verifying legacy-device transitional documentation.
What Changed in Version 8.0?
The change history confirms that Version 8.0 updates Chapter 5, specifically to add requirements concerning importer data in product registrations.
The change therefore reflects the continuing rollout of swissdamed and the gradual expansion of device and economic operator data requirements in Switzerland.
