A guide for Medical Devices Economic Operators in Switzerland

Introduction

On May 26, 2021, the new Medical Device Ordinance (MedDO, SR 812.213) entered into force in Switzerland. This piece of Swiss legislation largely implements the content of the EU Medical Device Regulation (EU) 2017/745. Nonetheless, due to the halt in the negotiations between the European Union and Switzerland on the MRA, some additional requirements have been introduced for manufacturers, distributors and importers who wish to place medical devices on the Swiss market.

To shed some light on the new regulatory framework applicable to Economic Operators, the Swiss Competent Authority (Swissmedic) published a guidance document outlining the obligations for Swiss Authorised Representatives, Distributors and Importers.

Swiss Authorised Representatives

As a consequence of the non-renewal of the Mutual Recognition Agreement between the EU and Switzerland, Manufacturers not established in Switzerland are now required to appoint a Swiss-based Authorized Representative (CH-REP)!

When to appoint your CH-REP?

Manufacturers established within the Union, or which have a European Authorized Representative can appoint a CH-REP according to the following deadlines:

• December 31, 2021: Class IIb implantable and class III devices;
• March 31, 2022: Class IIa and IIb devices (non-implantable);
• July 31, 2022: Class I devices, systems and procedure packs.

Instead, manufacturers not established within the EU and which do not have an EAR must appoint a CH-REP immediately.

Obligations

The role and obligations of the CH-REP, laid down in Art.51 MedDO, largely mirror the ones provided by the EU MDR. In particular, the CH-REP:

• Is responsible for formal and safety-related issues linked to the placing on the market of the device;
• Must be appointed through a written mandate singed with the manufacturer;
• Must have permanently and continuously at his disposal a Person Responsible for Regulatory Compliance (PRRC & Deputy PRRC);
• Must check that the Declaration of Conformity and the Technical documentation have been drawn up, and that the correct conformity assessment procedures have been carried out;
• Must ensure that the manufacturer’s obligations regarding the registration of devices are respected;
• Must cooperate with Swissmedic concerning preventative and corrective actions;
• Must keep available the Technical Documentation for 10 years (15 in case of implantable devices) after the last device was placed on the market;
• CH-REPs are held directly responsible for Vigilance notifications (both of incidents and Field Safety Corrective Actions to be reported to Swissmedic) and must communicate any complaint or report about suspicious incidents to the manufacturer.

Additionally, CH-REPs must register their activity with Swissmedic and obtain a Swiss Registration Number (CHRN). This should be completed within 3 months since the devices were placed on the Swiss market (if this occurred after May 26, 2021) or before November 26, 2021, for devices placed on the market before May 26, 2021.

Labeling requirements

As of May 26, 2021, manufacturers are required to indicate the CH-REP name and registered address of the business on the labels of the MDR-compliant devices they place on the Swiss market. In case of class I MDR devices, the CH-REP details can be indicated on a document accompanying the device, rather than on the label, until July 31, 2023. After this date, the information must be on the label. No derogation is provided for Class IIa, IIb, and III devices. In this case, the CH-REP details must appear on the label.

Non-Swiss manufacturers with an already appointed EU EAR have additional time. Mandatory labeling of CH-REP follows the transitional periods for appointing a CH-REP.

In the case of Legacy Devices, the CH-REP details can be featured either on the label or on the IFU of the device. Additionally, where the Legacy device is sold by an EU/EEA manufacturer or by a non-EU manufacturer with an appointed EU EAR, the CH-REP details can be included in a document accompanying the device, without a time limit.

Also, in the case of Legacy devices, mandatory labeling of CH-REP follows the transitional periods for appointing a CH-REP.

You can download the CH-REP logo from the Swissmedic website.

Importers

Obligations

According to MedDO, any natural or legal person in Switzerland that places a device from a foreign country on the Swiss market is considered to act as an importer and must comply with the obligations imposed by the Ordinance. In particular, importers must:

• Verify that the devices comply with MedDO before placing them on the market and inform the manufacturer and CH-REP in case a non-conformity is identified;
• Comply with the traceability obligations;
• Store and transport the devices as per the manufacturer’s instructions;
• Keep available the Declaration of Conformity and Certificates of Conformity for 10 years (15 in case of implantable devices) after the last device was placed on the market;
• Communicate any complaint or report about suspicious incidents to the manufacturer and, if applicable, to the CH-REP;
• Maintain a ‘Complaints’ list’ recording all complaints, non-conforming devices, recalls, and withdrawals;
• Cooperate within the supply chain on the investigation of complaints by providing the manufacturer, authorised representative, and distributors with any requested information;
• Assist the manufacturer with the implementation of corrective actions (e.g., recalls).

Swiss importers must register their activity with Swissmedic and obtain a Swiss Registration Number (CHRN). The process should be finalized within 3 months since the devices were placed on the market, in case devices were first placed on the Swiss market after May 26, 2021) or before November 26, 2021, for devices placed on the market before May 26, 2021).

Labeling requirements

The Importer’s name and registered address of business must be indicated on the device, or its packaging, or a document accompanying the device. For MDR-compliant devices, the importer’s details must be indicated as of May 26, 2021. In case of Legacy Devices, the deadline is July 31, 2022.

Distributors

Obligations

The guidance finally includes an overview of the obligations of Swiss distributors, i.e. any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the Swiss market, up until the point of putting into service.

Swiss distributors must:

• Verify that the devices comply with MedDO before placing them on the market and inform the manufacturer and CH-REP in case a non-conformity is identified;
• Comply with the traceability obligations;
• Store and transport the devices as per the manufacturer’s instructions;
• Keep available the Declaration of Conformity and Certificates of Conformity for 10 years (15 in case of implantable devices) after the last device was placed on the market;
• Communicate any complaint or report about suspicious incidents to the manufacturer and, if applicable, to the CH-REP;
• Maintain a ‘Complaints’ list’, recording all complaints, non-conforming devices, recalls and withdrawals;
• Keep the manufacturer and, where available, the CH-REP and the importer updated about the ‘Complaints List’ and provide them with any information upon their request;
• Assist the manufacturer with the implementation of corrective actions (e.g. recalls).

Unlike CH-REPs and importers, distributors are not required to register with Swissmedic to obtain a CHRN. Similarly, it is not necessary to indicate the details of the Swiss distributor on the device, nor on its labels, IFU or accompanying document.

Moreover, the appointment of a qualified PRRC and a deputy PRRC is mandatory only for CH-REPs and is not needed for importers and distributors.

Conclusions

While the non-renewal of the Mutual Recognition Agreement left the door open for uncertainty with regards to the regulatory framework for medical devices in Switzerland, the Swiss Competent Authority is constantly working to bring more clarity on the new requirements introduced by MedDO. Therefore, this guidance is certainly a must-read document for Economic Operators involved in the Swiss market for medical devices. You can find this and similar, helpful guides in our MDlaw Library of Documents.

Tommaso Poles

Research & Development Department

15/11/2021

Interested in selling your medical devices in Switzerland? Obelis can act as your Swiss Authorized Representative and turn your Swiss journey into a success story! Contact us today.

References:

Fedlex. (2021). 812.213 Medical Devices Ordinance of 1 July 2020 (MedDO). Retrieved on 16/11/2021  from https://www.fedlex.admin.ch/eli/cc/2020/552/en

Swissmedic. (2021). Obligations for authorised representatives, importers and distributors. Retrieved on 16/11/2021 from https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/pflichten-bevollmaechtigte.html