Switzerland: What (IVD) medical device manufacturers should be aware of

Switzerland is important both as a manufacturing location and as a market for medical device manufacturers who are based outside Switzerland.

However, since May 26, 2021 (for medical devices) and May 26, 2022 (for in vitro diagnostic devices | IVD medical devices), manufacturers from Switzerland as well as manufacturers from other markets (e.g., the EU) have had to overcome additional hurdles. Neither Switzerland nor the EU are in any doubt that this is intentional.

In order to continue to be able to legally market (IVD) medical devices in Switzerland and the EU, manufacturers must be fully aware of the new regulatory requirements and transitional periods. This article provides an overview of the requirements.

1. What has happened?

The end of the Mutual Recognition Agreement (MRA) …

The previously well-functioning economic relationship was hit by a double impact at the end of May 2021:

• The EU first replaced the Medical Device Directives (MDD and AIMDD) with the MDR (May 26, 2021) and then the In Vitro Diagnostics Directive (IVDD) with the IVDR (May 26, 2022).
• Switzerland broke off the negotiations for the renewal of the institutional framework agreement.

This means there will be no new Mutual Recognition Agreement (MRA). However, a renewal of the MRA would have been urgent and important for the MDR and IVDR.

Switzerland views the MRA as follows:

The MRA is an instrument designed to remove technical barriers to the trade of industrial goods between Switzerland and the EU.

Source: SECO

This MRA was vital for the mutual recognition of authorizations:

The Community and Switzerland […] grant mutual acceptance of reports, certificates, authorizations, and conformity marks issued […] and of the manufacturer’s declarations of conformity […].

Source: Swiss Fedelex

… makes Switzerland a “third country”

The end of this MRA and therefore mutual recognition means that

“For all new devices, Swiss manufacturers will be treated as any other third country manufacturer intending to place their devices on the EU market”

Source: EU

Similarly, EU medical device manufacturers can no longer place their medical devices on the market in Switzerland in the same way as before because Switzerland had to change the legal provisions accordingly.

2. Legal requirements for medical devices in Switzerland

The Swiss Ordinance on Medical Devices (MepV) of January 01, 2002  has been replaced by a new version . This new version leans heavily on the requirements of the MDR. The Swiss Ordinance on In-vitro Diagnostic Medical Devices (IvDV) came into force on May 26, 2022.

The requirements of the amended MepV and its effects for manufacturers in Switzerland and in the EU are described in the next chapter.

3. New obligations for EU manufacturers

Swissmedic no longer has access to EUDAMED and therefore has no access to European market surveillance data. The MepV and IvDV therefore introduce additional measures so that Switzerland can also track “foreign” medical devices in Switzerland.

a) Obligation to register devices and operators

Manufacturers or their authorized representatives and importers must register certain information (MepV Article 55/IvDV Article 48).

The information that has to be submitted for the registration is the same as that required by the MDR/IVDR (MDR Annex VI Part A Section 1/IVDR Annex VI Part A Section 1).

Registration must be completed within 3 months of the initial placing on the market. Changes must be reported to Swissmedic within one week.

The registration process is largely similar to that of the MDR. Swissmedic issues an identification number – the CHRN or Swiss Single Registration Number – to economic operators.

There is currently a limited registration requirement for medical devices (MepV Article 108 ). This only applies to economic operators based in Switzerland and custom-made devices (MepV Article 19). There is also a limited registration requirement for in vitro diagnostic medical devices (IvDV Article 10).

Distributors are not obliged to indicate their address on the device marking.

b) Obligation to name a Swiss authorized representative – with a specialty

The obligation for manufacturers not domiciled in Switzerland to designate a Swiss-authorized representative is also new (MepV Article 51 f./IvDV Article 44 f.).

The obligations of this person correspond to those of the EU representative in accordance with Article 11 MDR/IVDR. But there is one specialty :

This has the advantage that the manufacturer does not have to make its technical documentation permanently available to the authorized representative, as required by MDR/IVDR Article 11 (3) b) for the European authorized representative, which means that either a copy is held by the European authorized representative and must be kept up to date or the European authorized representative requires permanent access to the manufacturer’s documentation system. Swissmedic nevertheless expects the initial verification process of the technical documentation to be carried out. The authorized representative is also still obliged to ensure that the documentation is sent to Swissmedic within seven days.

There is no such option in the EU, even if a lot of manufacturers must wish there were.

c) Obligation of importers

In addition to the authorized representative, the manufacturer must also designate an importer (MepV Article 53/IvDV Article 46). Their obligations are the same as those of an EU importer according to MDR Article 13 and IVDR Article 13.

According to the new regulation, when new MDR/IVDR devices are imported into Switzerland, the importer must be indicated on the device, on the packaging, or on a document enclosed with the device (e.g., delivery slip, warranty, customs documents, invoice, sticker). The latter of these options makes it easier for manufacturers.

This labeling obligation for MDD/AIMD devices under old legislation are regulated separately for the different classifications in MepV Article 101.

d) Obligation to report problems

As Switzerland no longer has access to EUDAMED, reports (also) have to be sent to Swissmedic (MepV Article 66/IvDV Article 59). This concerns

• serious incidents and
• field safety corrective actions taken in Switzerland.

The notification can be carried out by the manufacturer or its Swiss-authorized representative, which should be clearly regulated in the contract between the two economic operators. However, the authorized representative is responsible for the reporting obligation.

Where an authorised representative is required pursuant to Article 51, this representative is responsible for the reporting obligation in paragraph 1. Furthermore, the authorised representative must submit the trend reports pursuant to paragraph 2 on incidents in Switzerland and abroad to Swissmedic without being requested to do so. Final reports prepared in accordance with Article 89 paragraph 5 EU-MDR should be submitted to Swissmedic. The transfer of these obligations from the manufacturer or from the natural or legal person assembling systems or procedure packs under Article 22 paragraphs 1 and 3 EU-MDR to the authorised representative must be agreed in writing in the mandate.

Source: MepV, Article 66

Where an authorised representative is required pursuant to Article 44, this representative is responsible for the reporting obligation in paragraph 1. Furthermore, the authorised representative shall submit the trend reports pursuant to paragraph 2 on incidents in Switzerland and abroad to Swissmedic without being requested to do so. Final reports prepared in accordance with Article 84 paragraph 5 EU-IVDR should be submitted to Swissmedic. The transfer of these obligations from the manufacturer to the authorised representative must be agreed in writing in the mandate.

Source: IvDV Article 59

e) Obligation to publish summary reports

Similar to the requirements of Article 32 of the MDR or Article 29 of the IVDR, manufacturers have to publish “Summaries of Safety and Clinical Performance” (SSCPs). This is required by the MepV in Article 63 or by the IvDV in Article 56.

However, Switzerland spares manufacturers from having to submit these SSCPs to Swissmedic’s database. It only requires manufacturers to

• publish these summaries and
• state on the labeling or in the instructions for use where they are available.

f) Obligations for device labeling

Simplified labeling for certain devices:

Swissmedic simplified some of the obligations for labeling in section 6 (page 15 for medical devices and page 16 for in-vitro diagnostic devices) of its information sheet on the obligations of economic operators  (last updated on November 01, 2023).

Distributors are not obliged to indicate their address on the device or in a document accompanying the device if they are only providing devices.

The manufacturer must always, without exception, be indicated on the device itself or on the packaging.

4. What EU manufacturers are spared

a) No additional requirements for their devices

The MepV and IvDV refer to the requirements of the MDR/IVDR at several points, particularly with regard to the:

• General safety and performance requirements according to Annex I
• UDI obligations
  • MDR according to Article 27 and Annex VI
  • IVDR according to Article 24 and Annex VI
• Classification rules according to Annex VIII

b) No additional labeling

Switzerland recognizes CE marking (MepV Article 13/IvDV Article 12).

Switzerland allows its own conformity marking as an alternative (MD with or without a designated body number, see Annex 5 of the MepV and Annex 4 of the IvDV).

Update: December 16, 2021

The industry association Swiss Medtech has commissioned and published a legal opinion (German) intended to clarify, among other things, the legal basis regarding the labeling of legacy devices. According to this opinion, manufacturers in the EU are not required to name a Swiss authorized representative on the label, on the outer packaging or in the instructions for use. This requires the certificate to be valid according to Art. 100 MepV. However, the legal opinion is not legally binding and can therefore not be used as a line of reasoning with Swissmedic.

c) No additional conformity assessments and certificates

Switzerland also recognizes certificates from EU notified bodies. It calls these “designated bodies.”

Certificates issued by bodies designated under EU law and domiciled in a state of the EU or European Economic Area (EEA) but not recognised by an international agreement are deemed equivalent to certificates issued by Swiss bodies if it can be credibly demonstrated that:

a) the conformity assessment procedures applied meet Swiss requirements; and

b) the certificates were issued by a body with an equivalent qualification to that required in Switzerland.

Source: MepV Article 25/IvDV Article 21

Therefore, certificates issued by EU notified bodies should still be accepted.

With regard to the validity of certificates issued by Swiss notified bodies, the European Commission is causing some confusion. In an official statement, it says that these will no longer be valid after May 26, 2021. However, for the notified body SQS it gives the following information in the NANDO database: 

Warning: As from 26 May 2021, the notified body is no longer able to issue new certificates under Directive 93/42/EEC, but only allowed to carry out surveillance activities for certificates validly issued under that Directive in the transitional period, as established in Article 120 of Regulation (EU) 2017/745.

Source: NANDO

5. Transitional provisions

The MepV determines the transitional periods in Articles 100, 101, and 104; the IvDV in Articles 81, 82, and 85.

a) Transitional periods regarding the MDR and IVDR

Some of the transitional provisions regarding the MDR and IVDR’s applicability and regarding the UDI’s affixing are taken over by the MepV from the MDR and the IvDV from the IVDR.

b) Transitional periods regarding the MepV: Swiss authorized representatives

Independently of these provisions, Switzerland grants EU manufacturers additional transitional periods, e.g., for the appointment of a Swiss authorized representative (MepV Article 104a and IvDV Article 86).

As the transitional periods for medical devices in accordance with MepV have expired (as of July 31, 2022), only the transitional periods in accordance with IvDV are listed below.

IVD class	transitional period (authorized representative)
class D devices:	December 31, 2022
class B and C devices:	March 31, 2023
class A devices:	July 31, 2023

C) Transitional periods regarding the MepV/IvDV: registration of economic operators

The transitional periods for economic operators have expired for both MepV (November 26, 2021) and IvDV (November 26, 2022).

This means that the standard period of three months after placing on the market for the first time applies to both medical devices and in vitro diagnostic medical devices.

¹ Manufacturers or their authorised representatives and importers must register the information required by Part A, Section 1, of Annex VI to EU-MDR*/EU-IVDR 48 with Swissmedic within three months of placing a device on the market for the first time.

² The economic operator in question must report any changes to the information provided to Swissmedic within one week.

Source: MepV Art. 55/IvDV Art. 48
*Reference to EU MDR inserted in italics by the author, as this is the only difference between Art. 55 and Art. 48 (1) and (2).

6. Requirements for Swiss companies

a) Requirements for Swiss manufacturers

Swiss manufacturers who want to place devices on the EU market are treated like third-country manufacturers. This means extensive new obligations for them. They now need an EU authorized representative and an importer.

In addition, like every other business, they have to

• register devices and economic operators in EUDAMED,
• report incidents,
• carry out post-market-surveillance, and
• go through conformity assessments for class I and higher devices with a notified body.

But they also benefit from the transitional periods of the MDR/IVDR.

b) Requirements for Swiss distributors

Switzerland considers Swiss distributors who import and sell devices from the EU as importers and, therefore, they have to fulfill the requirements of the MepV and IvDV for importers. These are largely similar to the MDR/IVDR requirements for importers.

7. Summary and conclusion

a) Overview

The MDR and IVDR have already increased the requirements for medical device manufacturers in the EU and in Switzerland. However, the fact that the EU and Switzerland couldn’t agree on an MRA further increases the effort.

manufacturer’s HQ	valid certificate	type of sale	effects on manufacturer and distributor (not a complete list)
EU	certificate under old legislation, MDD	direct in CH	MDD certificate is recognized (for transitional provisions, see MepV Art. 100, 101) Registration as manufacturer and of the authorized representative with Swissmedic
EU	certificate under old legislation, MDD	import by Swiss distributor	MDD certificate is recognized (for transitional provisions, see MepV Art. 100, 101) Registration as manufacturer and of the authorized representative with Swissmedic Distributors are not obliged to give their address on the device. Distributors can also act as authorized representatives but are not automatically the authorized representative.
EU	certificate under old legislation, IVDD	direct in CH	IVDD certificate is recognized (for transitional provisions, see IvDV Art. 81, 82) Registration as manufacturer (3-month deadline) and of the authorized representative (see the table above for deadlines) with Swissmedic
EU	certificate under old legislation, IVDD	import by Swiss distributor	IVDD certificate is recognized (for transitional provisions, see IvDV Art. 81, 82) Registration as manufacturer (3-month deadline) and of the authorized representative (see the table above for deadlines) with Swissmedic Distributors are not obliged to give their address on the device. Distributors can also act as authorized representatives but are not automatically the authorized representative.
EU	MDR	direct in CH	MDR certificate is recognized Registration (see table above for the deadline) with Swissmedic
EU	MDR	import by Swiss distributor	MDR certificate is recognized Registration as manufacturer and of the authorized representative with Swissmedic Importing distributor: Registration as importer (3-month deadline) Distributors can also act as authorized representatives but are not automatically the authorized representative.
EU	IVDR	direct in CH	IVDR certificate is recognized Registration of economic operators with Swissmedic. If the device was placed on the market prior to May 26, 2022, the transitional period is extended to November 26, 2022. Designation of an authorized representative within time periods stated in MepV Article 86
EU	IVDR	import by Swiss distributor	IVDR certificate is recognized Registration of economic operators with Swissmedic. If the device was placed on the market prior to May 26, 2022, the transitional period is extended to November 26, 2022. Importing distributor: Registration as importer (3-month deadline). If the device was placed on the market before May 26, 2022, the transitional period is extended to November 26, 2022. Distributors can also act as authorized representatives but are not automatically the authorized representative.
EU	no certificate	direct in CH	Conformity assessment with CE or MD according to the requirements of the MDR or IVDR, etc. – Preparation of the clinical evaluation and technical documentation according to EU MDR or EU IVDR – Naming of a Person Responsible for Regulatory Compliance Registration as manufacturer and of the authorized representative with Swissmedic (3 months after first placing on the market)
CH	CH MD/CH-IVD (no certificate under EU law)	direct in EU or via distributor/importer	Naming of an EU authorized representative and an importer EU MDR/EU IVDR conformity assessment, with notified body if necessary Registration in EUDAMED CE marking
CH	MDD/MDR IVDD/IVDR	direct in EU or via distributor/importer	All provisions of the EU MDR/EU IVDR apply, including the transitional provisions of EU MDR Article 120/EU-IVDR, Art. 110.

b) Conclusion

The medical device market is just as important for Switzerland as it is for the EU. The following figures make this clear:

economic area	businesses	employees	revenue	source
Switzerland:	1,400	63,000	CHF 18 bn	Medinsight (German)
EU	67,000	600,000	EUR 107 bn	BVMED (German)
Germany	15,000	235,000	EUR 34 bn	BVMED (German)

All companies are already groaning under the weight of the MDR and IVDR and see it as the greatest burden as, for example, surveys by BVMED and a Johner Institute survey of over 1000 manufacturers have shown.

However, these manufacturers are now being asked to spend more time and incur more costs with no benefit for the safety, performance, or clinical efficacy of their devices. Instead, the additional time and costs only further weaken Europe as a business location – explicitly including Switzerland – compared to its international competitors. A look at the United Kingdom gives an idea of the consequences.

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Change history:

• 2023-06-05: Revision with regard to IvDV, transitional periods updated
• 2022-01-28: New regulations added