Placing a device on the Swiss market
Switzerland is outside the EU, and Swissmedic administers the regulations that govern devices there; when no updated agreement with the EU followed the EU's Medical Device Regulation, Switzerland implemented its own. Getting a device onto the Swiss market turns on the representatives a manufacturer appoints, the approvals an investigation needs, registration and conformity assessment, and the surveillance, inspections and recalls that follow.
The Swiss regulatory framework
Switzerland is outside the EU and its common market, and several regulations govern medical devices there, administered by one competent authority, Swissmedic.
Since 1 June 2002 Switzerland had regulated medical devices with the EU through a mutual recognition agreement. The EU applied the Medical Device Regulation on 26 May 2021, and as of June 2022, because the agreement had not been updated, Swissmedic lacked official access to EUDAMED, the central European device database the regulation requires. As of June 2022, the EU was prepared to negotiate with Switzerland over transitional provisions of the agreement related to the regulation, because the EU delegation represents Switzerland's interests in the International Medical Device Regulators Forum. No agreement had been reached, so Switzerland implemented its own regulations under the revised Medical Devices Act. As of June 2022, Switzerland had, for now, worked its way through and was looking forward to an updated agreement with the EU.
Some of the key regulations are the following.
- the federal law on therapeutic products and medical devices, which guarantees safe and effective therapeutic products, medical devices included
- the Medical Devices Ordinance of 1 July 2020, which provides all provisions related to medical devices and is the legal basis for placing devices on the Swiss market
- the federal act on research involving human beings, which governs all requirements, ethics among them, when human beings are involved in research
- the ordinance on clinical trials for medical devices, which regulates the conduct, procedure, duties and responsibilities of the research ethics committee for device trials, and the registration of those trials
- the ordinance on clinical trials in human research, which regulates the same for clinical trials generally
Swissmedic's tasks across a device's life cycle include designating and inspecting conformity assessment bodies, renewing their designation and surveilling them; questions of intended use, classification and borderline products; approval and safety monitoring of trials with non-CE-labelled or off-label devices, and of combined trials with medicinal products and such devices; inspections of clinical trials; and inspections of hospitals, covering their reporting system, reprocessing and maintenance, and of companies, for cause and in support of foreign authorities.
Swiss representatives
Under the revised act a manufacturer must either have a registered place of business in Switzerland or appoint a natural or legal person domiciled there as its representative. The deadline for designating a Swiss authorised representative depended on the device's risk: 31 December 2021 for class III, class IIb implantable and active implantable devices; 31 March 2022 for non-implantable class IIb and class IIa devices; and 31 July 2022 for class I devices and for systems and procedure packs.
The manufacturer must also designate Swiss residents for three roles: a person responsible for regulatory compliance, a distributor that ensures the device is available on the Swiss market, and an importer that places it on that market from abroad. Each has a fiduciary duty to the manufacturer and the Swiss authority to keep to the mandate, and can, if required, end the mandate if the manufacturer acts against it. By contractual agreement with the authorised representative, the manufacturer can submit the technical documentation of a new device directly to Swissmedic instead of leaving it with the representative, but most authorised representatives ask the manufacturer for it.
Approval of clinical investigations
Switzerland mandates human clinical trials for specific medical devices, and the approval procedure depends on the trial's category. A category A, or post-market, investigation uses CE-labelled devices as their instructions state, and it goes only to the ethics committee. A category C, or pre-market, investigation uses devices that lack the label, are used outside its instructions or are prohibited in Switzerland. Before it starts, it needs the permission of both the cantonal ethics committee and Swissmedic, and submissions are made on the same day through the committee's BASEC portal and Swissmedic's eMessage portal. Under the rules applied from 26 May 2021, Swissmedic authorises only trials the ethics committee has approved. Once the trial is submitted on both portals, the complete documentation is reviewed in 38 days. The manufacturer or its authorised representative must submit technical documentation to start the investigation.
Registration and conformity assessment
Under the rules in force in June 2022, a new device had to be registered through Swissmedic and receive a CE label through a designated body before it was placed on the market. The account that gives this rule also has the manufacturer, authorised representative or importer register the device with Swissmedic within 30 days of introducing it to the Swiss market. Registration gives the device a unique device identification number. On request, Swissmedic assigns Swiss manufacturers, authorised representatives and importers a Swiss Single Registration Number, which must be obtained within three months of placing the device on the market and makes the device easier to trace and identify. As of June 2022, the process was to change once the mutual recognition agreement is updated, with manufacturers then receiving their unique identification numbers through EUDAMED.
After registration the device must meet conformity assessment standards, evaluated by designated bodies, before it is placed on the Swiss market. As of June 2022, a device certified by a notified body in an EU or European Economic Area member state is equivalent to one certified by a Swiss notified body. SQS (notified body 1250) is the local Swiss designated body for issuing the CE label, and the NANDO website lists foreign notified bodies. Certificates under the old ordinance of 2001 could no longer be issued after 26 May 2021, but those already issued remained valid until their expiry or 26 May 2024. Devices of class III, IIb, IIa and Is, Im or Ir and in vitro diagnostics involve a conformity assessment body, which audits the quality management system and assesses compliance with the fundamental requirements. Special additional procedures apply to certain class III and IIb products, to products involving tissues or cells of human or animal origin or their derivatives, and to substances or combinations of substances that the human body absorbs or that are distributed locally in it. For class I devices and products with no medical intended use, the manufacturer is responsible for verifying safety and performance.
How long a designated body takes to certify a device depends on the device's complexity, and for class IIa and IIb devices it is generally four to twelve months, with a follow-up review within three years. Compliance is attained once the device receives its CE label, and with it the device is ready for the Swiss and EU markets. The CE label is valid for five years and may be extended several times.
Swissmedic is continuously involved in conformity assessment: it reviews the documents the designated bodies issue, audits the bodies and publishes an annual surveillance report of the audits on its website.
Post-market surveillance, inspections and recalls
After launch the manufacturer keeps a post-market surveillance plan, writes a post-market surveillance report for class I devices and a periodic safety update report for class IIa, IIb and III devices, and collects and evaluates vigilance reports.
Swissmedic continuously inspects authorised representatives, importers and manufacturers, and it carries out the relevant inspections in hospitals, while the cantons inspect nursing homes and clinics. A foreign government may inspect devices in Switzerland if it notifies Swissmedic at least 30 days ahead, agrees the scope and extent with the company beforehand and delivers a copy of the inspection within ten days of issuing its report. If a device has problems, whoever first placed it on the Swiss market must recall it, and the manufacturer must report to Swissmedic what it did to resolve them.