Switzerland: What Medical Device Manufacturers Should Now Be Aware Of

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:

This MRA was vital for the mutual recognition of authorizations:

… makes Switzerland a “third country”

The end of this MRA and therefore mutual recognition means that

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The Swiss Medizinprodukteverordnung (MepV) of January 01, 2002 (German) has been replaced by a new version (German).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, authorized representatives and importers domiciled in Switzerland must register with Swissmedic once (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:

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.

According to the new regulation, when new MDR 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 last of these options makes things easier for manufacturers.

This labeling requirement only applies from July 31, 2022 in the case of devices imported into Switzerland that underwent the conformity assessment procedure under the MDD/AIMDD.

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

f) Device labeling requirements

Simplified labeling for certain devices:

Swissmedic simplified some of the requirements for labeling in section 6 of its information sheet on the obligations of economic operators on December 30, 2021.

The CH-REP and the importer can now also be indicated on a document accompanying the device (delivery slip, warranty, customs documents, invoice, etc.).

The following deadlines and conditions apply:

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 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:

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

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).

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.”

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: 

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)).

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:

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
• Run post-market-surveillance and
• Carry out conformity assessments for class I and higher devices with a notified body.

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.

b) Conclusion

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

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.