The first article provides a brief overview of the Swiss legislation in the sphere of medical devices, and also describes in detail the recent changes thereto.
Swissmedic, a Switzerland’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the procurement of medical devices by healthcare facilities, such as hospitals. The document is intended to provide additional clarifications regarding the evidence and proof of conformity required for the devices procured. The scope of the document covers both medicines and medical devices. In terms of the latter, it is based on the Medical Devices Ordinance (MepV; SR 812.213). Furthermore, the authority explicitly states that specific cases, such as the ones related to in-house manufactured medical devices, custom-made products, or the ones intended for clinical trials, are falling outside the scope of the present guidance.
Swiss Medical Device Regulations: Key Points
First of all, the document provides a brief overview of the current legislation on medical devices, as well as of the recent changes thereto. As it is mentioned in the document, the revised Swiss Medical Devices Act has entered into force on May 26, 2021. The new act is based on respective regulations implemented in the EU and is intended to introduce the same level of public health protection. The authority mentions that the implementation of new regulations on in-vitro diagnostic medical devices is scheduled for May 26, 2022.
Under the framework existing before, there was an agreement between Switzerland and the EU ensuring that Swiss medical devices could be marketed in the EU Member States. The aforementioned agreement also prescribed the way the Swiss regulating authority should cooperate with the respective national regulating authorities in the sphere of healthcare products to ensure efficient post-market surveillance and cooperation on other matters. At the same time, medical devices manufactured in the EU were allowed for marketing and use in Switzerland.
Since the Swiss national regulatory framework for medical devices has changed, the agreement with the EU should be amended respectively. At the same time, because it hasn’t been updated in time, additional regulatory requirements would become applicable. For instance, foreign medical device manufacturers would have to appoint local representatives in Switzerland. However, a special transitional regime will be introduced to prevent shortages in supply and ensure the uninterrupted availability of medical devices on the Swiss market. The new approach also imposes an obligation to register with Swissmedic.
According to the applicable legislation, medical device manufacturers are obliged to mark their products with a European harmonized identification number (a Unique Device Identifier, or UDI). However, the respective requirements would be introduced gradually till 2027 from when any medical devices intended to be marketed in Switzerland should have UDIs.
To increase the overall effectiveness of post-marketing surveillance and transparency in general, a new medical device database (EUDAMED) will be launched. The database will contain information on medical devices and respective EU certificates. At the moment, its implementation has been postponed, since not all the modules are already operational. Swissmedic mentions that it is expected the new database will be fully launched by the end of 2022.
Medical Devices: Definitions
The document also defines medical devices which stand for instruments, apparatus, software, materials, accessories, or other technical items:
- That is intended and advertised for use for diagnostic or therapeutic purposes; and
- Whose main effect in or on humans is not achieved by pharmacological, immunological, or metabolic means.
The definition provided hereinabove is outlined in the Medical Devices Ordinance. The authority further explains that all medical devices could be divided into two main groups: in-vitro diagnostic (IVD) devices and general medical devices. It is important to mention that by default the authority uses the term “medical devices” for general medical devices, while in the case of in-vitro diagnostic ones it is explicitly stated.
Swissmedic additionally emphasizes that products without a medical purpose that have similar risks to medical devices (e.g., lasers for hair removal, hyaluronic acid for wrinkle injections) are now also subject to medical device regulation. The appropriate regulatory matters would be addressed by the authority separately.
In-vitro diagnostic devices are the ones intended to be used as a reagent, reagent product, calibration material, control material, kit, instrument, apparatus, device, or system for in-vitro testing of samples derived from the human body. Under the previous framework, such products were regulated by the Directive 98/79/EC on in vitro diagnostic medical devices. Once the new framework will enter into force, these products would be subject to regulation under In Vitro Diagnostic devices Regulation 2017/746 (IVDR). This category covers such products as tests for determining blood groups, pregnancy tests, software for the evaluation of blood values, software for controlling a medical laboratory machine, and sample containers. The new regulation will apply to any medical devices, except the ones already placed on the market under the previous regulatory framework – such devices could be supplied under the transitional regime till May 27, 2025.
General medical devices were previously regulated by the Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices. Now both these Directives are replaced by the Medical Devices Regulation 2017/745 (MDR). This category includes a wide range of hardware medical devices and software products. As in the case with IVD devices, certain exceptions are applicable as well, namely:
- For Class I medical devices placed on the market under the previous framework, for which there are valid declarations of conformity, provided that under the new regime for such products an EU certificate will be required; and
- Medical devices are already placed on the market under the previous framework.
The aforementioned transitional period for general medical devices will continue till May 26, 2025.
Approval for Medical Devices
The authority states that for medical devices there is no formal approval procedure, as it exists for medicines. However, any medical device should meet the applicable safety and performance requirements. It is the sole responsibility of a medical device manufacturer to assess whether its product meets the aforementioned requirements. Should it be the case, the manufacturer is entitled to place a CE mark confirming compliance with the applicable regulatory requirements and place such a product on the market if the product in question is a Class I medical device associated with low risk. In the case of medium and high-risk medical devices, additional assessment by a duly designated conformity assessment (notified) body will be required. The latter would assess both the device itself and the quality management system implemented by its manufacturer. Should the manufacturer be able to demonstrate compliance with the applicable regulatory requirements, the notified body will issue the respective EU certificate.
In summary, the present document provides an overview of existing regulations on medical devices, as well as the recent changes thereto. The document highlights the most important aspects to be considered concerning medical devices intended to be marketed and used in Switzerland.
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