Switzerland: What Medical Device Manufacturers Should Now Be Aware Of

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

But since May 26, 2021, manufacturers of medical devices from Switzerland and manufacturers from other markets (e.g., the EU) have new additional hurdles to overcome. Similarly, Swiss manufacturers who want to market their devices in the EU also face new hurdles. Neither Switzerland nor the EU have left any room for doubt about this.

Therefore, if you want to be able to market medical devices legally in Switzerland or in the EU, it is important that you have detailed knowledge of the new regulatory requirements and transitional periods.

1. What has happened?

The end of the mutual recognition agreement…

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

  • The EU replaced the medical device directives (MDD and AIMDD) with the MDR.
  • Switzerland broke off negotiations for a new framework agreement.

This means there will be no new mutual recognition agreement (MRA) even though a renewal of the MRA was urgent and important for the MDR.

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 technology manufacturers can no longer place their medical devices on the market in Switzerland in the same way as before because Switzerland has changed the legal requirements accordingly.

2. Legal requirements for medical devices in Switzerland

The Swiss Medizinprodukteverordnung (MepV) of January 01, 2002 (German) has been replaced by a new version (German). This new version leans heavily on the requirements of the MDR and the IVDR.

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

3. New obligations for EU manufacturers

Swissmedic no longer has access to EUDAMED and, as a result, cannot access market surveillance data. Therefore, the MepV establishes additional measures so that Switzerland can also track “foreign” medical devices in Switzerland.

a) Obligation to register devices and operators

Manufacturers, Swiss authorized representatives and Swiss importers have to register with Swissmedic (MepV Article 55 (German)).

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

Registration must be completed within 3 months of the initial placing on the market. Changes must be notified within one week. Extended transitional provisions apply for economic operators who placed MDR-compliant medical devices on the market before May 26, 2021 (see below).

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 (German)). This only affects economic operators based in Switzerland. A precise date by which device registration for all devices and economic operators must be completed has not yet been established (MepV Article 110(2) (German)). For the registration of devices that have already been placed on the market, registration must be completed within 6 months of the start of the obligation to register according to Article 17(5).

b) Obligation to name a Swiss authorized representative – with one unique feature

The obligation to name a Swiss authorized representative is new (MepV Article 51 f. (German)).

Their rights and obligations are the same as those of EU authorized representatives according to Article 11 MDR. But there is one unique feature:

 Tip

The manufacturer and authorized representative can contractually agree that the authorized representative will not hold a copy of the technical documentation and that the manufacturer will provide the documentation directly to Swissmedic on request.

This has the advantage that the manufacturer does not have to disclose its technical documentation to the authorized representative. However, the authorized representative is still obliged to make sure that the technical documentation is delivered to Swissmedic within seven days.

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

c) Obligations of importers

In addition to the authorized representative, the manufacturer must also “install” an importer (MepV Article 53 (German)). Their obligations are the same as those of an EU importer according to MDR Article 13.

d) Obligation to report problems

As Switzerland no longer has access to EUDAMED, reports (also) have to be sent to Swissmedic (MepV Article 66 (German)). This affects:

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

There is a unique feature here as well: these reports must be sent by the Swiss authorized representative!

If an authorized representative is required according to Article 51, the authorized representative will be responsible for the report according to paragraph 1. In addition, the authorized representative must submit to Swissmedic, unrequested, the trend reports according to paragraph 2 regarding incidents in Switzerland and abroad. Final reports according to Article 89(5) EU MDR must be submitted to Swissmedic. The transferring of these obligations of the manufacturer or of the person assembling systems or procedure packs according to Articles 22(1) and 22(3) EU MDR to the authorized representative must be agreed in writing in the mandate.

Source: MepV, Article 66(German)

e) Obligation to publish summary reports

Similar to the requirements of Article 32 of the MDR, manufacturers have to publish “summaries of safety and clinical performance” (SSCPs). This is required by the MepV in Article 63 (German).

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

4. What EU manufacturers are still spared

a) No additional requirements for their devices

The MepV refers to the requirements of the MDR at several points, particularly with regard to the:

b) No additional labeling

Switzerland recognizes CE marking (MepV Article 13 (German)).

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

c) No additional conformity assessments and certificates

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

Certificates issued by designated bodies according to EU law established in an EU or EEA state and that are not recognized by an international agreement will be considered equivalent to certificates issued by Swiss bodies if it can be credibly demonstrated that:
a) the conformity assessment procedures used meet the Swiss requirements; and
b) they are issued by a body with a qualification equivalent to that required in Switzerland.

Source: MepV Article 25(German)

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

5. Transitional provisions

In Articles 100 (German), 101 and 104, the MepV establishes the transitional periods.

a) Transitional periods regarding the MDR

Part of the transitional provisions relates to those of the MDR. The MepV adopts the MDR provisions regarding the applicability of the MDR and the affixing of the UDI.

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 (Article 104a (German)).

Aspect

Transitional periods

Class III devices, implantable class IIb devices and active implantable medical devices

December 31, 2021

Non-implantable class IIb devices and class IIa devices

March 31, 2022

Class I devices

July 31, 2022

Systems and procedure packs

July 31, 2022

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

For economic operators who placed MDR-compliant devices on the market in Switzerland between November 26, 2017 and May 26, 2021, the MepV provides for an extended transitional period for registration:

Economic operators who placed devices on the market before May 26, 2021 according to Article 22a of the Medizinprodukteverordnung of October 17, 2001 must register according to Article 55(1) and (5) before November 26, 2021

Source: MepV Article 104b (German)

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:

But they also benefit from the MDR’s transitional periods.

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 for importers. These are largely similar to the MDR requirements for importers.

7. Summary and conclusion

a) Overview

The MDR has 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 law, MDD

Direct in CH


MDD certificate is recognized (for transitional provisions, see MepV Art. 99, 100 (German))

Registration as manufacturer (3-month deadline) and of the authorized representative (see the table above for deadlines) with Swissmedic

EU

Certificate under old law, MDD

Import by Swiss distributor

MDD certificate is recognized (for transitional provisions, see MepV Art. 99, 100 (German))

Registration as manufacturer (3-month deadline) and of the authorized representative (see the table above for deadlines) with Swissmedic

Importing distributor: Registration as importer (3-month deadline)

Distributors can also act as authorized representative, but are not automatically the authorized representative

EU

MDR

Direct in CH


MDR certificate is recognized

Registration as manufacturer (3-month deadline) and of the authorized representative (see the table above for deadlines) with Swissmedic. If the device was placed on the market before May 26, 2021, the transitional period is extended to November 26, 2021.

EU

MDR


 

Import by Swiss distributor

MDR certificate is recognized

Registration as manufacturer (3-month deadline) and of the authorized representative (see the table above for deadlines) with Swissmedic. If the device was placed on the market before May 26, 2021, the transitional period is extended to November 26, 2021.

Importing distributor: Registration as importer (3-month deadline). If the device was placed on the market before May 26, 2021, the transitional period is extended to November 26, 2021.

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, etc.

– Preparation of the clinical evaluation and technical documentation according to EU MDR

– Naming of a person responsible for regulatory compliance

Registration as manufacturer (3-month deadline) and of the authorized representative (see the table above for deadlines) with Swissmedic.

CH


 

CH MD (no certificate under EU law)

Direct in EU or via distributor/importer


Naming of an EU authorized representative and an importer

EU MDR conformity assessment, with notified body if necessary

Registration in EUDAMED

CE marking

CH

MDD

/MDR

Direct in EU or via distributor/importer


All provisions of the EU MDR apply, including the transitional provisions of EU MDR Article 120

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:

14,000

63,000

CHF 18 bn

Medinsight

EU

67,000

600,000

EUR 107 bn

BVMED

Germany

15,000

235,000

EUR 34 bn

BVMED

All companies are already groaning under the weight of the MDR 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.


Johner Medical GmbH helps Swiss companies who want to market their devices in the EU by acting as the EU authorized representative. Johner Institute Schweiz GmbH helps EU companies who want to market their devices in Switzerland by acting as the CH authorized representative. Just get in contact with us.

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