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

Switzerland is not an EU member. Market access for regulated products rests on two instruments. The EU-CH Mutual Recognition Agreement (signed in Luxembourg on 21 June 1999, in force since 1 June 2002, OJ L 114 of 30 April 2002) makes a conformity assessment done once, in the EU or in Switzerland, valid on both markets for the 20 sectors in its Annex 1. Swiss sector ordinances then accept the CE marking as a "foreign conformity mark" (for example Annex 1 point 2 of the telecommunications installations ordinance OIT and of the EMC ordinance OCEM). Medical devices are the exception: since 26 May 2021 the EU has not updated the medical-device chapter, and Swiss law requires a Swiss authorised representative (CH-REP).

Which Swiss federal authorities regulate electronic products?

OFCOM (BAKOM) applies the OIT for radio equipment and is the control body of the EMC ordinance OCEM (Art. 24 OCEM). ESTI, the Federal Inspectorate for Heavy Current Installations, is the competent authority for low-voltage electrical equipment under the OMBT (Art. 4 OMBT). METAS and the cantons check measuring instruments in service (Art. 26 OIMes). Swissmedic applies the Medical Devices Ordinance MedDO. SECO administers the MRA and runs the machinery file.

What does MRA Annex 1 cover, and how current is it?

Annex 1 has 20 chapters: machinery, PPE, toys, medical devices, gas appliances and boilers, pressure equipment, radio equipment, ATEX, electrical equipment and EMC, outdoor noise of construction plant, measuring instruments and pre-packaged products, motor vehicles, tractors, GLP, GMP, construction products, lifts, biocidal products, cableway installations and civil explosives. The last amendment to Annex 1 is Decision No 2/2017 of the Joint Committee of 22 December 2017. The chapters still cite Directive 2006/42/EC for machinery and the old medical-device directives; no EU act adopted after 2017 has been added.

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

Chapter 4 lists Directives 90/385/EEC, 93/42/EEC and 98/79/EC, plus only Chapter IV and Annex VII of Regulations 2017/745 and 2017/746 (notified-body designation), added in 2017. When the MDR applied on 26 May 2021 the chapter was not updated; the Federal Office of Public Health states that the EU has treated Switzerland as a third country for medical devices since then. The Federal Council factsheet of 13 June 2025 says the EU has refused to update the agreement since May 2021 because of unresolved institutional issues.

Who needs to appoint a CH-REP and by when?

Under Art. 51 MedDO, a device whose manufacturer is not domiciled in Switzerland may only be placed on the Swiss market if a Swiss-domiciled authorised representative is designated by written mandate. For EU or EEA manufacturers, Art. 104a set the deadlines: 31 December 2021 for class III, implantable class IIb and active implantable devices; 31 March 2022 for non-implantable class IIb and class IIa; 31 July 2022 for class I, systems and procedure packs. All have passed. Since 26 May 2021 the manufacturer and CH-REP may agree that the manufacturer sends the technical documentation straight to Swissmedic on request, within seven days (Art. 51(3bis)).

Do radio products need anything Swiss-specific?

The OIT mirrors the RED. The CE marking is accepted (Annex 1 point 2 OIT), the declaration of conformity may be in an official language or in English (Art. 15(3)), and the device must come with its frequency bands, maximum power and any operating restrictions (Art. 19). The OFCOM ordinance OOIT made the RED cybersecurity requirements (d), (e) and (f) apply from 1 August 2025, as in the EU, and set the USB Type-C deadlines at 27 December 2024 and, for laptops, 27 April 2026.

What languages are required in Switzerland?

It depends on the ordinance. For low-voltage equipment, instructions and safety information must be in at least the official language or languages of the place where the product is made available (Art. 11 OMBT). For medical devices, product information must be in all three official languages, with exceptions for devices supplied only to professionals (Art. 16 MedDO). Declarations of conformity under the OIT, OCEM and OMBT may be written in an official language or in English. The general rule in Art. 4a of the Federal Act on Technical Barriers to Trade is at least one official language.

What did the March 2026 EU-CH package change for the MRA?

Nothing yet in force. The package (Bilaterals III) was signed on 2 March 2026 and the Federal Council adopted its dispatch to Parliament on 13 March 2026. It includes an Institutional Protocol and an Amending Protocol to the MRA, which enter into force only after both parties have notified completion of their procedures for the whole set of listed protocols. The Amending Protocol lets EU or Swiss economic operators fulfil obligations for either market and gives Switzerland observer status in the Medical Device Coordination Group.

Switzerland: product certification and the EU-CH MRA

Hugues Orgitello updated 7 Oct 2026 16 min read

Switzerland is not in the European Union, yet a CE-marked radio module, power supply or machine usually reaches the Swiss market with no second assessment. Two instruments make that work: the EU-CH Mutual Recognition Agreement (MRA), signed on 21 June 1999 and in force since 1 June 2002, and Swiss ordinances that copy EU product law and accept the CE marking as a "foreign conformity mark". The MRA Annex 1 was last amended on 22 December 2017, so it still cites Directive 2006/42/EC and the pre-MDR medical-device directives, and medical devices have needed a Swiss-specific route since 26 May 2021. This page reads the agreement text, the Swiss ordinances (OIT, OMBT, OCEM, MedDO, OMach, LETC) and the March 2026 amending protocol, article by article.

Two layers: the MRA and Swiss law

The MRA is an equivalence agreement. Section 9.2.2 of the Commission Blue Guide (2022) calls it an "enhanced MRA": it covers conformity assessments whatever the origin of the product, and works only because Switzerland aligned its legislation with EU law in the covered sectors. Certificates from Swiss bodies accredited by the Swiss Accreditation Service (SAS) are deemed equivalent to those of EU bodies within the MRA scope, and the reverse. The Blue Guide also notes that there is no customs union between the EU and Switzerland, that Switzerland is a full member of CEN, CENELEC and ETSI, and that a parallel MRA with the same scope binds the EEA EFTA States and Switzerland (Annex I to the EFTA Vaduz Convention, in force 1 June 2002).

Under the MRA sits Swiss law. The Federal Act on Technical Barriers to Trade (LETC/THG, RS 946.51) sets three rules that matter for a product file:

LETC article	What it says
Art. 16a (in force 1 July 2010)	"Cassis de Dijon" principle: a product meeting EU technical rules (or, where EU law is not or only partly harmonised, the rules of an EU or EEA state) and lawfully on that market may be placed on the Swiss market. Excluded: products subject to approval, notifiable chemicals, products needing prior import authorisation or under an import ban, and Federal Council exceptions
Art. 18	A test report or certificate has probative value if the body is accredited in Switzerland, recognised under an international agreement, or otherwise authorised by Swiss law. A foreign body outside those cases is accepted only if equivalence of procedures and qualifications is made credible
Art. 4a	Product information must be in at least one official language; warnings and safety instructions may be required in more than one, or in the language(s) of the place of sale

The MRA is administered on the Swiss side by SECO, which publishes the agreement, its Joint Committee decisions and the consolidated English version.

MRA Annex 1: the 20 chapters and the EU acts they cite

The 1999 text had 15 chapters. The consolidated version of 22 December 2017 has 20, and the Blue Guide and SECO both speak of 20 product sectors. The EU acts listed below are the ones Section I of each chapter cites today.

Chapter	Title	EU acts cited (Section I)
1	Machinery	Directive 2006/42/EC
2	Personal protective equipment	Regulation (EU) 2016/425
3	Toys	Directive 2009/48/EC
4	Medical devices	Directives 90/385/EEC, 93/42/EEC, 98/79/EC; only Chapter IV and Annex VII of Regulations (EU) 2017/745 and 2017/746
5	Gas appliances and boilers	Regulation (EU) 2016/426; Directive 92/42/EEC for hot-water boilers under Article 1(1) only
6	Pressure equipment	Directives 2014/29/EU, 2014/68/EU, 2010/35/EU
7	Radio equipment and telecommunications terminal equipment	Directive 2014/53/EU (RED)
8	Equipment for potentially explosive atmospheres (ATEX)	Directive 2014/34/EU
9	Electrical equipment and EMC	Directives 2014/35/EU (LVD) and 2014/30/EU
10	Construction plant and equipment (outdoor noise)	Directive 2000/14/EC
11	Measuring instruments and pre-packaged products	Directives 2014/31/EU and 2014/32/EU among others; pre-packaged products under Article 1(1) only
12	Motor vehicles	Directive 2007/46/EC and related acts
13	Agricultural or forestry tractors	Tractor directives
14	Good laboratory practice	Chemical and product regulations listed in the chapter
15	Medicinal products, GMP inspection and batch certification	Medicinal product legislation
16	Construction products	Regulation (EU) No 305/2011
17	Lifts	Directive 2014/33/EU
18	Biocidal products	Regulation (EU) No 528/2012
19	Cableway installations	Regulation (EU) 2016/424
20	Explosives for civil use	Directive 2014/28/EU

Two things follow for an electronics team. First, Article 1(1) chapters (hot-water boilers, pre-packaged products) are not mutual recognition of results under equivalent law; SECO lists them as the sectors where Swiss and EU legislation are not deemed equivalent. Second, nothing adopted by the EU after 2017 is in Annex 1: not the Machinery Regulation (EU) 2023/1230, not the RED delegated acts as Annex 1 entries, not the Cyber Resilience Act, not the MDR beyond its notified-body chapter. Ecodesign, RoHS, batteries and recreational craft were never MRA chapters.

Economic operators: what the MRA spares an EU manufacturer

Chapters 7 (radio) and 9 (LVD and EMC) each contain a Section V "Economic operators" clause, added when the chapters were aligned on the 2014 directives. They state that EU and Swiss economic operators are subject to equivalent obligations and remove duplicates:

Obligation (RED article / LVD-EMC article)	What is sufficient under the MRA
Name and postal address on the product (RED 10(7), 12(3); EMC 7(6), 9(3); LVD 6(6), 8(3))	The address of the manufacturer established in either the EU or Switzerland; if the manufacturer is outside both, the address of an importer established in either
Keeping the technical documentation and declaration for 10 years (RED 10(4), 12(8); EMC 7(3), 9(7); LVD 6(3), 8(8))	Kept by the manufacturer established in either the EU or Switzerland, or by the importer in either if the manufacturer is outside both
Sample testing and complaint registers (RED 10(5), 12(6); LVD 6(4), 8(6))	Fulfilled by the manufacturer in either territory, or the importer in either

Read alone, Art. 18(6) of the Swiss OIT requires the name and address of the importer when the manufacturer is not established in Switzerland. The MRA chapter 7 clause is what lets an EU manufacturer address satisfy that Swiss provision. The Federal Council factsheet of 13 June 2025 makes the same point from the export side: thanks to the MRA, a Swiss machine maker does not have to appoint an EU importer or authorised representative or relabel its products.

Medical devices: chapter 4 and the MedDO route

Chapter 4 still lists the three pre-MDR directives. The 2017 decisions added only Chapter IV and Annex VII of the MDR and IVDR (designation and supervision of notified bodies), so the chapter could prepare the transition but not cover devices certified under the regulations. The Federal Office of Public Health (FOPH) states that the Commission has not updated chapter 4 since the MDR applied in May 2021, and that Switzerland has been treated as a third country for medical devices since then. The IVD side followed when the In Vitro Diagnostic Medical Devices Ordinance of 4 May 2022 applied, on 26 May 2022.

The Swiss Medical Devices Ordinance (MedDO, RS 812.213, last amended 1 July 2026) sets the Swiss route:

MedDO article	Rule
Art. 13(1)	Devices must bear the Swiss conformity marking of Annex 5; the CE marking of MDR Annex V is also permissible
Art. 16(2) and (3)	Product information in all three official languages; fewer languages or English allowed when the device goes only to healthcare professionals (or is custom-made or in-house), the user agrees and is qualified, and safety is not affected
Art. 17(5) and 108(2)	UDI data must be registered with Swissmedic; for devices placed on the market from 1 July 2026, registration is due by 31 December 2026
Art. 25(4)	Certificates from EU or EEA bodies not recognised by an international agreement are equivalent to Swiss ones if it is made credible that the procedures meet Swiss requirements and the body has equivalent qualifications
Art. 51(1)	A manufacturer not domiciled in Switzerland needs a Swiss-domiciled authorised representative (CH-REP), by written mandate
Art. 51(3bis)	Manufacturer and CH-REP may agree that the manufacturer sends the technical documentation straight to Swissmedic on request; the CH-REP ensures it arrives within seven days
Art. 51(5)	The same applies to non-Swiss assemblers of systems and procedure packs

CH-REP deadlines (Art. 104a MedDO)

Devices from an EU or EEA manufacturer (or one with an EU or EEA representative)	CH-REP required by
Class III, implantable class IIb, active implantable	31 December 2021
Non-implantable class IIb, class IIa	31 March 2022
Class I	31 July 2022
Systems and procedure packs	31 July 2022

All four deadlines have passed. Until 31 July 2023, Art. 104a bis allowed class I devices and systems or procedure packs to give the CH-REP details in an accompanying document rather than on the label.

A separate Swiss track concerns devices approved outside Europe. Both chambers adopted Motion 20.3211 on 28 November 2022, and on 30 April 2025 the Federal Council decided that devices approved by the US FDA should be able to reach the Swiss market under conditions checked by private bodies, according to the FOPH. The FOPH page gives no date of application.

Radio equipment: OIT and the OFCOM ordinance

The Ordinance on telecommunications installations (OIT/FAV, RS 784.101.2) transposes the RED; OFCOM sets the details in its own ordinance (OOIT, RS 784.101.21).

Provision	Swiss rule
OIT Art. 7(1) to (3)	Essential requirements of RED Art. 3: safety (by reference to the OMBT, without voltage limits), EMC (by reference to the OCEM), efficient use of spectrum, and additional requirements set by OFCOM "taking account of the corresponding delegated acts of the European Commission"
OIT Art. 7(2bis), OOIT Annex 7	Common charger: USB Type-C per EN IEC 62680-1-3:2022, USB Power Delivery above 5 V, 3 A or 15 W
OOIT Art. 10c	Non-compliant devices of Annex 7 points 1.1 to 1.12 could be placed on the market until 27 December 2024; laptops (point 1.13) until 27 April 2026
OOIT Annex 1 points 7 to 9	Delegated Regulation (EU) 2022/30 requirements (d), (e), (f): internet-connected equipment, equipment processing personal data (childcare, toys, wearables), equipment handling money; medical and IVD devices excluded as in the EU
OOIT Art. 10b	Equipment not meeting (d), (e), (f) could be placed on the market until 31 July 2025, so the requirements apply from 1 August 2025
OIT Art. 9	Equipment may be made available only if it meets the spectrum-use requirements of at least one OFCOM technical interface regulation
OIT Art. 15(3)	Declaration of conformity in an official language or in English
OIT Art. 18, Annex 1	Swiss "CH" mark or the CE marking of Regulation (EC) No 765/2008
OIT Art. 19(2) and (3)	Frequency bands, maximum transmitted power and any operating restrictions (including a licence obligation) must accompany the device; restrictions also on the packaging
OOIT Art. 2a	On CE-marked equipment, operating restrictions are shown by the pictogram of OOIT Annex 6 or by "restrictions or requirements in" followed by the countries

In practice, a RED file built for the EU, including the Delegated Regulation 2022/30 assessment, addresses the same OIT requirements. What a radio team still checks is the OFCOM technical interface regulations for each band used, in particular for less common technologies such as UWB, because OIT Art. 9 ties market access to them.

Low-voltage equipment and EMC: OMBT and OCEM

Provision	Rule
OMBT Art. 4(1)	Economic operator obligations follow Articles 6 to 9 of the LVD; ESTI is the competent authority
OMBT Art. 4(2)	The obligation to affix the CE marking does not apply in Switzerland; a CE marking already affixed under EU rules need not be removed
OMBT Art. 11	Instructions and safety information in at least the official language(s) of the place where the equipment is made available
OMBT Art. 8(4)	Declaration of conformity in an official language or in English; conformity with EU law may be declared per LVD Annex IV
OCEM Art. 11(2)	EMC declaration of conformity in an official language or in English
OCEM Art. 13, Annex 1	Swiss "CH" mark or the CE marking accepted
OCEM Art. 24	OFCOM checks that equipment on the market complies, by sampling and on suspicion

The split of control matters when a product is challenged: ESTI handles electrical safety of low-voltage equipment, OFCOM handles EMC and radio.

Machinery: Directive 2006/42/EC in the MRA, Regulation 2023/1230 coming

MRA chapter 1 cites Directive 2006/42/EC, and the Swiss Machinery Ordinance (OMach, RS 819.14) still defines its scope by that directive. Since 20 January 2024 a partial revision lets Swiss conformity assessment bodies seek accreditation for Regulation (EU) 2023/1230 under the requirements of Article 30 of that regulation (OMach Art. 4(1bis)), matching the EU date from which those provisions apply.

The full switch is still in preparation. The Federal Department of Economic Affairs, Education and Research opened the consultation on the total revision of the OMach on 19 September 2025, with a deadline of 19 December 2025; the stated aim is to take over the EU Machinery Regulation by reference, equivalently and at the same time, since it applies in the EU from 20 January 2027. As of 7 October 2026 Fedlex shows no consolidated OMach version that applies the regulation. For the EU side, see Machinery Directive 2006/42/EC and Regulation 2023/1230.

Measuring instruments: MRA placing, Swiss checks in service

Chapter 11 covers Directives 2014/31/EU (NAWI) and 2014/32/EU (MID), so a CE and M-marked instrument is placed on the Swiss market without a new assessment. Use is another matter. Under the Measuring Instruments Ordinance (OIMes, RS 941.210), the competent bodies check measurement stability periodically for as long as the instrument is used (Art. 24) and run general inspections (Art. 25); the cantons carry out the controls the federal law gives them, and METAS the rest (Art. 26). See MID 2014/32/EU for the EU framework.

The 2026 package: what the MRA amending protocol changes

Date	Step
18 March 2024	EU-CH negotiations open
December 2024	Negotiations concluded in substance
13 June 2025	Federal Council approves the negotiated agreements; consultation June to October 2025
2 March 2026	Package signed
13 March 2026	Federal Council adopts the dispatch to Parliament
Not yet	Entry into force: the Amending Protocol enters into force on the first day of the second month after the last notification for the full set of listed protocols

The Amending Protocol to the MRA, as published by the Federal Department of Foreign Affairs, does three things a product team will notice:

General provisions for Annex 1. Where EU acts in Annex 1 assign obligations to economic operators established in the EU or Switzerland, those obligations can also be met by operators established in the other party, unless a chapter provides otherwise (new Article 4). This generalises what chapters 7 and 9 already do.
Medical devices. Chapter 4 will state that Switzerland participates in the Committee on Medical Devices and the Medical Device Coordination Group as an observer.
Boilers. Chapter 5 is rewritten so that it covers Regulation (EU) 2016/426 and the energy efficiency and emissions requirements of Directive 92/42/EEC.

According to the Federal Council factsheet, the institutional elements will make the MRA adapt regularly to EU law, Switzerland will take part in EU market surveillance, the exception for pre-packaged products stays, and neither protocol requires a change to Swiss law. The factsheet says the 20 MRA sectors account for 73% of Swiss industrial exports to the EU. Until entry into force, the factsheet states that the parties cooperate under arrangements in place since the end of 2024; it does not say the medical-device chapter has been updated, so the MedDO route above still applies.

Practical mapping: EU act to Swiss route (October 2026)

EU instrument	MRA chapter	Swiss act	Practical route
RED 2014/53/EU	7, operational	OIT, OOIT (OFCOM)	EU file and CE accepted; check OFCOM interface regulations, restriction marking
RED Delegated Regulation 2022/30	Not in Annex 1	OOIT Annex 1 points 7 to 9	Same requirements, same date (1 August 2025) under Swiss law
LVD 2014/35/EU	9, operational	OMBT (ESTI)	EU file accepted; CE optional under OMBT Art. 4(2); local-language instructions
EMC 2014/30/EU	9, operational	OCEM (OFCOM)	EU file and CE accepted
Machinery 2006/42/EC	1, operational	OMach (SECO)	EU file accepted until the switch to 2023/1230
Machinery Regulation 2023/1230	Not in Annex 1	OMach revision under consultation	Watch the Swiss adoption before 20 January 2027
ATEX 2014/34/EU	8, operational	Swiss sector ordinance	EU file accepted under the MRA
MID 2014/32/EU, NAWI 2014/31/EU	11, operational for placing	OIMes (METAS, cantons)	CE and M accepted; Swiss checks in service
MDR 2017/745	4, not updated since May 2021	MedDO (Swissmedic)	CH-REP, Swiss UDI registration, three languages
IVDR 2017/746	4, not updated	IvDO (Swissmedic)	Swiss IVD route since 26 May 2022
Cyber Resilience Act (EU) 2024/2847	Not in Annex 1	Not covered by the MRA	Check Swiss law separately; see the CRA guide for the EU side

Claims the texts contradict

Claim (including ones this page made before)	What the text says
The MRA has an ecodesign chapter, a recreational craft chapter and covers RoHS	None of the 20 chapters of the consolidated Annex 1 covers ecodesign, recreational craft or RoHS
Simple pressure vessels and non-automatic weighing instruments are separate chapters	Directive 2014/29/EU sits in chapter 6 (pressure equipment), Directive 2014/31/EU in chapter 11 (measuring instruments)
There is a separate IVD chapter that lapsed on 26 May 2022	IVDs are in chapter 4 with medical devices (Directive 98/79/EC); the IVD route changed when the Swiss IvDO applied on 26 May 2022
MRA erosion started in 2019	Annex 1 was last amended by Decision No 2/2017 of 22 December 2017; the Federal Council dates the EU refusal to update from May 2021
ESTI oversees EMC for low-voltage products	OCEM Art. 24 makes OFCOM the EMC control body; ESTI is competent under the OMBT for electrical safety
An EU manufacturer must appoint a Swiss economic operator for CE products	For radio, LVD and EMC, MRA chapters 7 and 9 Section V accept the address and records of a manufacturer established in either the EU or Switzerland
Consumer products need German, French and Italian manuals everywhere in Switzerland	OMBT Art. 11 asks for the official language(s) of the place where the product is made available; LETC Art. 4a sets at least one official language as the base rule. All three languages are required by MedDO Art. 16 for medical devices
The CH-REP must hold the technical documentation in Switzerland	Since 26 May 2021, Art. 51(3bis) MedDO allows the manufacturer to send it directly to Swissmedic on request, within seven days
The medical-device trilingual rule only covers consumer-facing items	Art. 16(2) MedDO applies to all devices; the exceptions in Art. 16(3) are for professional supply, custom-made and in-house devices, with conditions
Switzerland decided not to sign the institutional framework in 2021, so the MRA cannot be updated	A new package with an MRA Institutional Protocol and Amending Protocol was signed on 2 March 2026; it is not yet in force
The MRA covers the Machinery Regulation 2023/1230	Chapter 1 cites Directive 2006/42/EC only; the Swiss takeover of 2023/1230 was still in preparation (consultation 19 September to 19 December 2025)

Common pitfalls

Pitfall	Consequence
Treating CE marking as a Swiss passport for medical devices	MedDO Art. 51 blocks placing without a CH-REP
Missing the Swiss UDI registration for devices placed from 1 July 2026	Registration with Swissmedic is due by 31 December 2026 (MedDO Art. 108(2))
Shipping English-only safety instructions with low-voltage equipment	OMBT Art. 11 requires the official language(s) of the place of sale
Assuming an MRA chapter follows new EU acts automatically	Annex 1 is frozen at December 2017 until the 2026 protocols enter into force
Skipping the OFCOM interface regulation check for a band	OIT Art. 9 makes market access depend on meeting at least one of them
Reporting a Swiss incident only to the EU	MedDO vigilance (Art. 66 reporting) goes to Swissmedic
Confusing MID placing with Swiss use	CE and M placing is recognised; OIMes in-service checks still apply

Frequently asked questions

Is Switzerland in the EU, and does CE marking grant access on its own?: Switzerland is not an EU member. Market access for regulated products rests on two instruments. The EU-CH Mutual Recognition Agreement (signed in Luxembourg on 21 June 1999, in force since 1 June 2002, OJ L 114 of 30 April 2002) makes a conformity assessment done once, in the EU or in Switzerland, valid on both markets for the 20 sectors in its Annex 1. Swiss sector ordinances then accept the CE marking as a "foreign conformity mark" (for example Annex 1 point 2 of the telecommunications installations ordinance OIT and of the EMC ordinance OCEM). Medical devices are the exception: since 26 May 2021 the EU has not updated the medical-device chapter, and Swiss law requires a Swiss authorised representative (CH-REP).
Which Swiss federal authorities regulate electronic products?: OFCOM (BAKOM) applies the OIT for radio equipment and is the control body of the EMC ordinance OCEM (Art. 24 OCEM). ESTI, the Federal Inspectorate for Heavy Current Installations, is the competent authority for low-voltage electrical equipment under the OMBT (Art. 4 OMBT). METAS and the cantons check measuring instruments in service (Art. 26 OIMes). Swissmedic applies the Medical Devices Ordinance MedDO. SECO administers the MRA and runs the machinery file.
What does MRA Annex 1 cover, and how current is it?: Annex 1 has 20 chapters: machinery, PPE, toys, medical devices, gas appliances and boilers, pressure equipment, radio equipment, ATEX, electrical equipment and EMC, outdoor noise of construction plant, measuring instruments and pre-packaged products, motor vehicles, tractors, GLP, GMP, construction products, lifts, biocidal products, cableway installations and civil explosives. The last amendment to Annex 1 is Decision No 2/2017 of the Joint Committee of 22 December 2017. The chapters still cite Directive 2006/42/EC for machinery and the old medical-device directives; no EU act adopted after 2017 has been added.
Why did the MRA medical-device chapter stop working in May 2021?: Chapter 4 lists Directives 90/385/EEC, 93/42/EEC and 98/79/EC, plus only Chapter IV and Annex VII of Regulations 2017/745 and 2017/746 (notified-body designation), added in 2017. When the MDR applied on 26 May 2021 the chapter was not updated; the Federal Office of Public Health states that the EU has treated Switzerland as a third country for medical devices since then. The Federal Council factsheet of 13 June 2025 says the EU has refused to update the agreement since May 2021 because of unresolved institutional issues.
Who needs to appoint a CH-REP and by when?: Under Art. 51 MedDO, a device whose manufacturer is not domiciled in Switzerland may only be placed on the Swiss market if a Swiss-domiciled authorised representative is designated by written mandate. For EU or EEA manufacturers, Art. 104a set the deadlines: 31 December 2021 for class III, implantable class IIb and active implantable devices; 31 March 2022 for non-implantable class IIb and class IIa; 31 July 2022 for class I, systems and procedure packs. All have passed. Since 26 May 2021 the manufacturer and CH-REP may agree that the manufacturer sends the technical documentation straight to Swissmedic on request, within seven days (Art. 51(3bis)).
Do radio products need anything Swiss-specific?: The OIT mirrors the RED. The CE marking is accepted (Annex 1 point 2 OIT), the declaration of conformity may be in an official language or in English (Art. 15(3)), and the device must come with its frequency bands, maximum power and any operating restrictions (Art. 19). The OFCOM ordinance OOIT made the RED cybersecurity requirements (d), (e) and (f) apply from 1 August 2025, as in the EU, and set the USB Type-C deadlines at 27 December 2024 and, for laptops, 27 April 2026.
What languages are required in Switzerland?: It depends on the ordinance. For low-voltage equipment, instructions and safety information must be in at least the official language or languages of the place where the product is made available (Art. 11 OMBT). For medical devices, product information must be in all three official languages, with exceptions for devices supplied only to professionals (Art. 16 MedDO). Declarations of conformity under the OIT, OCEM and OMBT may be written in an official language or in English. The general rule in Art. 4a of the Federal Act on Technical Barriers to Trade is at least one official language.
What did the March 2026 EU-CH package change for the MRA?: Nothing yet in force. The package (Bilaterals III) was signed on 2 March 2026 and the Federal Council adopted its dispatch to Parliament on 13 March 2026. It includes an Institutional Protocol and an Amending Protocol to the MRA, which enter into force only after both parties have notified completion of their procedures for the whole set of listed protocols. The Amending Protocol lets EU or Swiss economic operators fulfil obligations for either market and gives Switzerland observer status in the Medical Device Coordination Group.