Is Switzerland in the EU, and does CE marking grant access on its own?

No. Switzerland is not a member of the European Union, nor of the European Economic Area. For most product categories covered by EU harmonised legislation, market access is organised through the Mutual Recognition Agreement (MRA) signed between the European Community and the Swiss Confederation in 1999 and in force since 2002. Annex 1 of that MRA lists the product chapters where Swiss and EU conformity assessment are recognised reciprocally. For those chapters, a CE-marked product compliant with the applicable directive may, in practice, be placed on the Swiss market without a second conformity procedure. The MRA has been progressively eroded since 2019, and the medical-device chapter is no longer operational since 26 May 2021, so the CE-alone shortcut does not apply to every category any more.

Which Swiss federal authorities regulate electronic products?

Four federal authorities cover the bulk of the perimeter for an electronic or radio product. OFCOM, the Federal Office of Communications (BAKOM in German, OFCOM in French and English), governs radio and telecommunication equipment and the Swiss frequency plan. METAS, the Federal Institute of Metrology, governs measuring instruments and non-automatic weighing instruments. ESTI, the Inspectorate for Electrical Installations, oversees electrical safety and electromagnetic compatibility for low-voltage products. Swissmedic, the Swiss Agency for Therapeutic Products, governs medical devices and in-vitro diagnostic medical devices. Other sectors (pressure equipment, machinery, gas appliances) fall under the State Secretariat for Economic Affairs SECO and sectoral offices.

What is the EU-CH MRA Annex 1 and which categories does it cover?

Annex 1 of the MRA lists the product chapters covered by mutual recognition. It covers, among others, machinery, personal protective equipment, toys, simple pressure vessels, electromagnetic compatibility, electrical equipment and low-voltage equipment, gas appliances and boilers, measuring instruments and non-automatic weighing instruments, lifts, pressure equipment, explosives for civil uses, biocidal products, recreational craft, civil explosives, ecodesign requirements and ATEX equipment. The structure follows the same logic as the EU New Legislative Framework: the MRA references the same directives and regulations, and qualifies Swiss conformity assessment bodies as equivalent to EU notified bodies for the chapters in force.

Why did the MRA medical-device chapter stop working in May 2021?

The MRA chapter on medical devices was tied to the predecessor directives MDD 93/42/EEC and AIMDD 90/385/EEC. When EU Regulation 2017/745 (MDR) entered into application on 26 May 2021, the chapter was not updated, because negotiations on the broader EU-CH institutional framework had stalled. From that date, the EU treats Switzerland as a third country for medical devices, and Switzerland reciprocally treats the EU as a third country. A device CE-marked under MDR therefore does not automatically gain Swiss-market access, and an EU-based manufacturer must appoint a Swiss authorised representative (CH-REP). The same logic applies in mirror to IVDR since its full date of application on 26 May 2022.

Who needs to appoint a CH-REP and what does the role cover?

A CH-REP, the Swiss authorised representative, is required for any manufacturer not established in Switzerland who places a medical device or in-vitro diagnostic medical device on the Swiss market. The role is defined by the Swiss Medical Devices Ordinance MedDO (Ordinance 812.213) and its IVD counterpart IvDO. The CH-REP is registered with Swissmedic, holds the technical documentation in Switzerland, ensures the declaration of conformity is available, cooperates with Swissmedic on vigilance and market-surveillance requests, and is named on the device label or instructions for use. Failure to appoint a CH-REP is a structural non-conformity that blocks Swiss-market placing.

Are Swiss radio frequency bands aligned with the EU plan?

Largely yes, but not entirely. OFCOM publishes the Swiss National Frequency Allocation Plan (NaFAP) and the short-range device (SRD) authorisations through its own regulatory instruments. For most consumer bands (Bluetooth, Wi-Fi, LPWAN), the Swiss conditions mirror the corresponding ERC and CEPT decisions used in the EU, and a product compliant with the EU RED 2014/53/EU at the radio layer can rely on the MRA chapter for placing on the market. Some specifics remain, in particular on certain professional or military bands, and on the use of UWB. Verification on the OFCOM site is part of the radio-design check, not an optional step.

What languages are required for Swiss-market labelling and manuals?

Switzerland has four national languages: German, French, Italian and Romansh. For consumer-facing products, instructions for use, safety warnings and labels must be available in at least the languages of the cantons where the product is placed on the market. In practice, manufacturers covering the whole Swiss market provide trilingual documentation in German, French and Italian. Romansh is required only in specific cantonal contexts. For medical devices, the trilingual rule is explicit in the MedDO for consumer-facing items. English-only manuals are non-compliant for products sold to end users.

What changes practically when the MRA chapter for a category lapses?

When an MRA chapter is no longer operational for a given category (as happened for medical devices), the Swiss authority requires a conformity route under Swiss law alone. The product must still be CE-compliant for EU placing, but Swiss-market access now goes through Swiss-specific obligations: a Swiss-resident representative (CH-REP for medical devices), registration with the competent Swiss authority, Swiss-language documentation, and a clear chain of economic operators on the Swiss side. The EU notified body certificate remains usable as a substantive conformity element, but the institutional path is now national. See [MDR](/en/guides/mdr-medical-device-regulation/) for the EU side and the MedDO references below for the Swiss side.

Switzerland: product certification and the EU-CH MRA

Author Hugues Orgitello Last updated 27 May 2026 ~10 min read

Guide · Switzerland (EU-CH MRA)

Switzerland is not a member of the European Union, nor of the European Economic Area. Access to the Swiss market for products covered by EU harmonised legislation is organised through the Mutual Recognition Agreement (MRA) signed in 1999 and in force since 2002, complemented by Swiss federal law on a category-by-category basis. The MRA framework has been progressively eroded since 2019, most visibly with the medical-device chapter becoming non-operational on 26 May 2021. This page describes the Swiss federal architecture (OFCOM, METAS, ESTI, Swissmedic), the structure of MRA Annex 1, the categories where CE marking still grants effective access, the categories where a Swiss-specific route is now required, and the recurring pitfalls in a Swiss-market dossier.

Constitutional framework: Switzerland, EU and EEA

The Swiss Confederation is not a member of the European Union. It is also not a member of the European Economic Area (EEA), following the negative referendum of 6 December 1992. Relations between Switzerland and the EU are governed by a set of bilateral agreements known as Bilaterals I (signed 1999, in force 2002) and Bilaterals II (signed 2004, in force from 2005 onwards), each agreement covering a specific sectoral perimeter.

The bilateral agreement directly relevant to product conformity is the Agreement on Mutual Recognition in relation to Conformity Assessment, commonly called the EU-CH MRA. It is the legal vehicle that allows a CE-marked product, for the categories listed in its Annex 1, to circulate on the Swiss market without a second Swiss conformity procedure, and reciprocally for a Swiss-assessed product to enter the EU market without a second European procedure.

The MRA is administered on the Swiss side by the State Secretariat for Economic Affairs (SECO), with sectoral coordination by the federal offices in charge of each product chapter. The institutional update of the MRA depends on a Joint Committee that meets periodically. Since 2019, several updates have not been adopted because of the broader stalemate on the EU-CH institutional framework agreement, which Switzerland decided not to sign in May 2021. This stalemate is the root cause of the chapter-by-chapter erosion described below.

Swiss federal regulators by scope

Authority	Acronym	Scope
Federal Office of Communications	OFCOM (BAKOM)	Radio and telecommunication equipment, frequency plan, market surveillance of radio products
Federal Institute of Metrology	METAS	Measuring instruments, non-automatic weighing instruments, legal metrology
Inspectorate for Electrical Installations	ESTI	Low-voltage electrical safety, EMC for low-voltage equipment, market surveillance
Swiss Agency for Therapeutic Products	Swissmedic	Medical devices, in-vitro diagnostic medical devices, medicinal products
Federal Office of Public Health	FOPH (OFSP)	Public-health interaction with medical devices, sectoral coordination
State Secretariat for Economic Affairs	SECO	Machinery, pressure equipment, civil explosives, MRA administration

OFCOM and ESTI cooperate on the radio/EMC boundary: OFCOM holds the radio dossier, ESTI runs market surveillance of EMC for the low-voltage perimeter. Swissmedic and FOPH cooperate on the medical-device side, with Swissmedic operating as the technical authority and FOPH on the public-health policy side.

EU-CH MRA Annex 1: structure

MRA Annex 1 is the operational core of the agreement. It is divided into product chapters, each chapter referencing the corresponding EU directives or regulations and the equivalent Swiss federal law. Around twenty chapters are listed, covering the typical perimeter of the New Legislative Framework on the EU side.

MRA Annex 1 chapter	EU instrument referenced	Swiss authority
Machinery	Directive 2006/42/EC	SECO
Personal protective equipment	Regulation 2016/425	SECO
Toys	Directive 2009/48/EC	Federal Food Safety Office
Simple pressure vessels	Directive 2014/29/EU	SECO
Pressure equipment	Directive 2014/68/EU	SECO
Electromagnetic compatibility	Directive 2014/30/EU	ESTI
Electrical equipment and low-voltage equipment	Directive 2014/35/EU	ESTI
Gas appliances and boilers	Regulation 2016/426	SECO
Measuring instruments	Directive 2014/32/EU	METAS
Non-automatic weighing instruments	Directive 2014/31/EU	METAS
Lifts	Directive 2014/33/EU	SECO
Equipment for explosive atmospheres (ATEX)	Directive 2014/34/EU	ESTI / SECO
Civil explosives	Directive 2014/28/EU	SECO
Recreational craft	Directive 2013/53/EU	Federal Roads Office
Ecodesign	Directive 2009/125/EC	Federal Office of Energy
Biocidal products	Regulation 528/2012	Federal Office for the Environment

Two chapters of historical importance no longer function as a mutual-recognition shortcut: the medical-device chapter (since 26 May 2021) and the in-vitro diagnostic chapter (since 26 May 2022). The radio equipment chapter, referencing RED 2014/53/EU, remains operational and is the primary entry point for transmitters into the Swiss market.

Timeline of MRA erosion (selected milestones)

Date	Event	Effect on product access
1999, in force 2002	MRA signed and entered into force	Establishes mutual recognition for the Annex 1 chapters
2002 to 2018	Periodic updates by the Joint Committee	Annex 1 kept aligned with successive EU regulatory packages
2019	Joint-Committee updates start stalling	Several new EU regulatory packages no longer reflected in the MRA
26 May 2021	MDR enters into application; medical chapter not updated	EU treats Switzerland as a third country for medical devices; CH-REP required
26 May 2022	IVDR full date of application; IVD chapter not updated	Same logic applied to in-vitro diagnostics
2021 onwards	Institutional framework agreement not signed by Switzerland	Broader EU-CH stalemate that blocks further MRA modernisation

For an electronics manufacturer, the practical reading is: for non-medical, non-IVD product chapters, the MRA chapter still functions and CE compliance is the effective passport. For medical and IVD, a Swiss-specific dossier is now mandatory in addition to the EU MDR/IVDR file.

Categories where CE alone (via MRA) is enough

For an electronic or radio product not falling under MDR/IVDR or under measuring-instrument legal metrology, the typical Swiss-market path remains the MRA chapter. The conformity assessment carried out for the EU is recognised on the Swiss side, and the CE-marked product can be placed on the Swiss market subject to the language requirements and to the appointment of a Swiss economic operator if the manufacturer is not established in Switzerland.

Product type	EU regime	Swiss path
IT and multimedia equipment, low-voltage	LVD 2014/35/EU, EMCD 2014/30/EU	MRA chapters Electrical / EMC, ESTI surveillance
Radio product (Bluetooth, Wi-Fi, LPWAN, cellular)	RED 2014/53/EU	MRA chapter RED, OFCOM surveillance and frequency conditions
Household appliance	LVD, EMCD, possibly Ecodesign	MRA chapters, ESTI surveillance
Machinery	Directive 2006/42/EC	MRA chapter Machinery, SECO surveillance
ATEX equipment	Directive 2014/34/EU	MRA chapter ATEX, ESTI surveillance
Personal protective equipment	Regulation 2016/425	MRA chapter PPE, SECO surveillance

For these categories, the technical file produced for the EU is admissible on the Swiss side, including notified-body certificates where applicable. The Swiss authority does not require a separate Swiss conformity body to re-certify the product.

Categories where a Swiss-specific route is required

Two structural exceptions in 2026: medical devices and in-vitro diagnostic medical devices. A third group sits one step apart: measuring instruments under legal metrology, where METAS coordinates with the EU framework but national approval is required for instrument placing in some sub-categories.

Medical devices: MedDO and CH-REP

The Swiss Medical Devices Ordinance, MedDO (Ordinance 812.213), transposes the substance of EU MDR 2017/745 into Swiss law, but remains a Swiss instrument. Since the MRA medical chapter is no longer operational from 26 May 2021, Swissmedic treats EU-based manufacturers as third-country manufacturers. The structural consequences are:

A CH-REP (Swiss authorised representative) must be designated, established in Switzerland, registered with Swissmedic, and named on the device label or instructions for use.
The CH-REP holds the technical documentation in Switzerland, ensures the declaration of conformity is available, and is the Swissmedic point of contact for vigilance, post-market surveillance and field safety corrective actions.
The device must carry the CH-REP identification on the label, in addition to the CE marking and the notified body number used for the MDR file.
Swiss-language documentation rules apply (German / French / Italian for consumer-facing items).
The EU MDR notified-body certificate remains the substantive basis: Swissmedic does not require a separate Swiss conformity body to issue a parallel certificate, but the institutional declaration of conformity for the Swiss market follows the MedDO path.

The same logic applies to in-vitro diagnostic devices under the Swiss IvDO (Ordinance 812.219) since 26 May 2022.

Measuring instruments: METAS

For measuring instruments covered by EU MID 2014/32/EU or by NAWI 2014/31/EU (non-automatic weighing instruments), the MRA chapters are operational. However, for legal-metrology placing in service in Switzerland (verification before first use, periodic verification by cantonal verification offices), METAS retains national prerogatives. The CE/M-marked instrument is accepted as type-examined, but periodic verification on Swiss territory falls under cantonal verification, coordinated by METAS. See MID 2014/32/EU for the EU framework that underpins the MRA chapter.

OFCOM, radio frequencies and the Swiss frequency plan

OFCOM publishes the Swiss National Frequency Allocation Plan (NaFAP) and the conditions of use for short-range devices, drawing on CEPT/ERC decisions. For most consumer bands, the Swiss conditions mirror the EU plan adopted by ETSI in the harmonised standards underpinning RED 2014/53/EU.

The points to verify on each radio dossier targeting Switzerland:

Band-by-band conditions on the OFCOM site for the bands used by the product (sub-GHz LPWAN, 2.4 GHz, 5 GHz Wi-Fi, 6 GHz Wi-Fi 6E if applicable, UWB).
Equipment class under the Swiss telecommunications equipment ordinance (OIT in French, FAV in German).
Notification or general authorisation depending on the band: most consumer SRDs operate under general authorisation; some bands require a specific licence (professional, satellite).
Operator licensing, distinct from equipment placing, for bands used by network operators.

For the most common consumer cases (Bluetooth, Wi-Fi up to 5 GHz, LoRaWAN in the 868 MHz band, Sigfox), the RED dossier produced for the EU is directly usable, and the MRA radio chapter applies. Verification of UWB, 6 GHz and 60 GHz conditions against the current OFCOM publication is a separate due-diligence step.

Trilingual labelling and consumer information

Switzerland has four national languages (German, French, Italian, Romansh). The federal language regime, complemented by cantonal rules, requires that consumer-facing information be available in the language of the canton where the product is placed on the market. In practice:

Item	Typical Swiss-market rule
Instructions for use, consumer product	German + French + Italian
Safety warnings, consumer product	German + French + Italian
Commercial label	Mandatory information in at least the three languages above
Industrial or professional product	German + French (Italian recommended)
Medical device, consumer-facing	German + French + Italian (MedDO)
Romansh	Required in specific cantonal contexts only

English-only manuals are non-compliant for products sold to end users in Switzerland. For B2B products sold exclusively to industrial or professional users in a single language area, a single national language may be acceptable, but the conservative practice for a manufacturer placing through general distribution is trilingual documentation.

Practical mapping: EU directive to Swiss route

For an electronics product team, the typical mapping reads as follows.

EU instrument	MRA chapter operational?	Swiss authority	Practical route
LVD 2014/35/EU	Yes	ESTI	CE via MRA
EMCD 2014/30/EU	Yes	ESTI	CE via MRA
RED 2014/53/EU	Yes	OFCOM	CE via MRA, verify Swiss frequency plan
Machinery 2006/42/EC	Yes	SECO	CE via MRA
ATEX 2014/34/EU	Yes	ESTI / SECO	CE via MRA
PPE 2016/425	Yes	SECO	CE via MRA
RoHS 2011/65/EU	Yes (via ChemO)	Federal Office for the Environment	CE via MRA
MID 2014/32/EU	Yes (placing)	METAS	CE/M via MRA, cantonal verification in service
NAWI 2014/31/EU	Yes (placing)	METAS	CE/M via MRA, cantonal verification in service
MDR 2017/745	No, since 26 May 2021	Swissmedic	MedDO route, CH-REP mandatory
IVDR 2017/746	No, since 26 May 2022	Swissmedic	IvDO route, CH-REP mandatory

See CE marking for the EU baseline, MDR for the medical-device EU regime, and MID 2014/32/EU for the measuring-instrument framework that underpins the METAS interface.

Common pitfalls

Pitfall	Consequence
Treating CE marking as automatically valid in Switzerland in 2026	Correct for most categories, but wrong for medical devices and IVDs since 2021 and 2022
Not appointing a CH-REP for a medical device sold in Switzerland	Structural non-conformity blocking Swiss-market placing
Assuming MedDO follows MDR exactly	Substantively close, but the institutional path and labelling differ; CH-REP identification is a Swiss requirement
English-only manuals on consumer products	Non-compliant under Swiss language rules; market surveillance ground for withdrawal
Skipping OFCOM frequency-plan verification on UWB or 6 GHz radios	Risk of band-condition mismatch even where the RED dossier is valid for the EU
Confusing METAS legal-metrology placing-in-service with EU MID placing on the market	EU type-examination is recognised, but cantonal verification before use is a separate Swiss step
Ignoring the MRA Joint-Committee status before launching a Swiss-market campaign	An assumption that a chapter is operational can be wrong if updates stalled
Routing a Swiss-market medical recall through the EU Eudamed alone	Vigilance reporting to Swissmedic via the CH-REP is the Swiss-side obligation