Placing on the market of important non-conforming medical devices for combating the COVID-19 pandemic

29.06.2020

On 3 April 2020, the Swiss Federal Council approved various measures designed to guarantee the supply of medical articles that are crucial for preventing and combating the coronavirus disease COVID-19.

According to the Ordinance 3 on Measures to Combat the Coronavirus (COVID-19, COVID-19 Ordinance 3, SR 818.101.24) in the fight against the new coronavirus SARS-CoV-2 Swissmedic can, following a risk assessment, grant exemptions for the placing on the market of medical devices that are urgently needed to combat the COVID-19 epidemic, even if the required conformity assessment procedure according to Art. 10 of the Medical Devices Ordinance (MedDO, SR 812.213) has not been performed or completed.

This option is designed to improve the supply of urgently needed medical devices for the treatment or detection of the disease (e.g. ventilators, surgical masks, COVID-19 in-vitro diagnostic devices).

Remark:
Non-conforming surgical masks placed on the market exclusively for non-medical purposes are exempted from the exemption authorization under certain conditions. You can find more information at this link:

  • Criteria for the evaluation of the application by Swissmedic

As part of the risk assessment Swissmedic considers the following:

a) the conformity with the essential requirements and the existence of sufficient evidence of efficacy and performance, taking into account the intended purpose of the device. The risks associated with the intended use of the device must be acceptable in relation to the benefit for the patient; and
b) the increased demand from the national emergency services in relation to the type and quantity of the medical devices.

  • Who can submit an application?
    • An application can be submitted by a Swiss person who places the products on the market (e.g. manufacturer, distributor, importer), healthcare facility (e.g. hospital, nursing home) or other institution (e.g. federal agency, cantonal authority, association, society).
    • The applicant must have a registered office in Switzerland and is responsible for compliance with any restrictions and conditions and for the product surveillance.
  • How is an application submitted?

Applications must include the information and documentation needed for the evaluation (see criteria listed above), but at least:

1. Full contact details of the Swiss applicant (addressee of the official decision), who is responsible for complying with any restrictions and conditions and for the product surveillance.
2. Description of the device, part numbers, labelling, packaging and instructions for use.
3. Demonstration of conformity with the essential requirements, including:

a. Demonstration of compliance with the applicable (harmonised) medical device-specific (EN) ISO standards (e.g. EN 14683 for surgical masks, EN 60601-1 and EN 60601-2-12 for ventilators for intensive care…)
b. Demonstration of efficacy and performance of the device (including demonstration of clinical efficacy, Performance evaluation of in vitro diagnostic medical devices according to EN 13612).

4. Description of non-conformity (conformities).
5. Evaluation of the risks associated with the intended use of the device in relation to the benefit for the patient (benefit/risk ratio), taking account of the non-conformities stated under point 4.
6. Demonstration of certification of the manufacturer's quality management system
7. Demonstration of any authorisations in other non-EU countries (e.g. USA, China).
8. Estimate of the number of units to be placed on the Swiss market.

Corresponding applications should be sent to 

Incomplete applications will not be processed.