Update on Medical Device Regulations in Switzerland
The European Economic Area (EEA) is formed by the 27 member states of the European Union as well as the 3 EFTA countries, Iceland, Norway & Lichtenstein (view map of the EEA ) – as such, one can wonder, what is the status of Switzerland within this league of nations and how medical devices are regulated in this market?
Switzerland, while being the 4th member of EFTA is not part of the EEA. It has decided not to sign the EEA Agreement or the succeeding secondary legislation (“acquis communautaire”) and as such, excluded itself from being part of the EEA. However, Switzerland benefits from an active observer status in the EEA structures through its administration of the bilateral Swiss-EU agreements.
How to place Medical Devices on the Swiss market?
Specifically on medical devices medical devices, Switzerland concluded treaties (bilateral agreements or mutual recognition agreements – MRAs) with EU Member States, EFTA States and Turkey with regard to the mutual recognitions of conformity assessments as well as mandatory reporting requirements and direct distribution between Switzerland, the EEA and Turkey. Meaning, companies with registered offices in the said countries may freely distribute compliant medical devices directly to each other, without the need of having registered offices in the individual territories. The same applies for Non-EU manufacturers, designating an European Authorized Representative (EAR) within the EU – they will not be required to designate another authorized representative in Switzerland or vice versa.
None the less, country-specific requirements relating to medical devices remain valid (e.g. mandatory notifications, languages requirements, distribution channels, advertising and more). As such, Switzerland is free to introduce independent requirements under its national legislations for medical devices sold within its borders.
In Switzerland, enforcement on medical devices is conducted by the Swiss Agency for Therapeutic Products, Swissmedic, (in some cases, also by the Cantonal Authorities), primarily on the basis of:
- The Federal law on medicinal products and medical devices (Law on Therapeutic Products, Heilmittelgesetz HMG);
- The Medical devices ordinance (Medizinprodukteverordnung MepV);
- The Ordinance on clinical trials of therapeutic products (Verordnung über klinische Versuche mit Heilmitteln VKlin);
These legal texts transpose requirements of the European medical device legislations, such as the (MDD 93/42/EEC, IVD 98/79/EC, AIMDD 90/385/EEC.into Swiss law and specify additional national requirements in addition to the relevant EC Directives & CE markingrequirements.
Do Medical Devices require a Pre-Market Registration in Switzerland?
Companies and individuals must notify the placement in the Swiss market of any of the below product types (or changes to such information) towards the SATPs Swissmedic under the following conditions:
- Medical devices in Class I – however, the Notification of a Class I medical device to an EU Authority (e.g. by an Authorized Representative) does not need to be repeated towards the SATPs Swissmedic.
- In vitro diagnostic medical devices – however, by Decision 2010/227/EU, the Notification of an In-Vitro medical device to an EU Authority (e.g. by an Authorized Representative) does not need to be repeated towards the SATPs Swissmedic.
- Custom made devices – however, the Notification of a custom made medical device to an EU Authority (e.g. by an Authorized Representative) does not need to be repeated towards the SATPs Swissmedic.
- Systems or procedure packs – however, the Notification of a custom made medical device to an EU Authority (e.g. by an Authorized Representative) does not need to be repeated towards the SATPs Swissmedic.
- Classical and active implantable medical devices which are derived from human tissue which has been rendered non-viable.
- Classes IIa, IIb and III, and active implantable medical devices – while a conformity assessment by a Notified Body is required to be carried out for such devices, they do not require the completion of a National Device Registration (as implemented by Italy, Portugal, France, Greece or Latvia) in reference to the first placing on the Swiss market.
The Labeling & Instructions for Use (IFU) sent to any EU states, EFTA state or Switzerland must at the very least be in the official language(s) of the country they are to be sold in (additional languages may appear), in accordance to the language requirements under the national laws – The use of the device needs to be able to know what he bought and how to use it.
Need more information? Contact us now!Get in touch