Following an increasing number of devastating incidents involving defective medical devices in the past - such as leaking silicone breast implants or faulty hip prostheses - the control mechanisms for such medical devices have recently been tightened across Europe. Switzerland, too, has revised its national medical device regulations in close alignment with the EU provisions. This article provides an overview of the general changes to be considered by all actors in the medical device value chain.
I. Reasons for the Revision
The revision of medical device law aims to improve the quality and safety of medical devices and thus patient safety. To this end, the regulatory requirements for the players involved are being tightened considerably.
At the same time, Switzerland should continue to be able to participate as an equal partner in the European internal market for medical devices in view of the subsequent revision. As the competent authority at national level, Swissmedic ensures effective and efficient market surveillance of medical devices in conjunction with the competent authorities of the EU member states. For Swiss manufacturers, access to the European internal market thus remains guaranteed.
The corresponding adjustments to Swiss medical device legislation are being carried out by the Federal Office of Public Health (FOPH) on behalf of the Federal Department of Home Affairs (FDHA). This is done in close cooperation with Swissmedic, the State Secretariat for Economic Affairs (SECO) and the Directorate for European Affairs (DEA).
Gleichzeitig soll die Schweiz angesichts der nachgeführten Revision weiterhin als gleichberechtigter Partner am europäischen Binnenmarkt für Medizinprodukte teilnehmen können. Swissmedic stellt dabei als zuständige Behörde auf nationaler Ebene im Verbund mit den zuständigen Behörden der Mitgliedstaaten der EU eine effektive und effiziente Marktüberwachung von Medizinprodukten sicher. Für Schweizer Hersteller bleibt der Zugang zum europäischen Binnenmarkt damit weiterhin gewährleistet.
Die entsprechenden Anpassungen im Schweizer Medizinprodukterecht werden durch das Bundesamt für Gesundheit (BAG) im Auftrag des Eidgenössischen Departements des Innern (EDI) wahrgenommen. Dies erfolgt in enger Zusammenarbeit mit Swissmedic, dem Staatssekretariat für Wirtschaft (SECO) und der Direktion für europäische Angelegenheiten (DEA).
II. General Changes
The revision of the medical device law is in part very extensive and entails profound changes with regard to the reporting, control, conformity and documentation obligations of the various actors:
- In a tightening of regulation, the scope of medical device law has been expanded to include products without a medical purpose - such as contact lenses without correction - if they are similar to medical devices in terms of their functionality and associated risk.
- The distributors are now subdivided into manufacturers, importers and dealers and are subject to graduated liability - depending on the intensity of the impact possibilities.
- All market players will have more obligations and will be more closely involved in monitoring. Manufacturers must also regularly prepare a safety report on their products.
- The personnel of the inspection bodies are confronted with higher requirements regarding their qualification.
- Higher requirements are also being placed on conformity, product monitoring and proof of the clinical effectiveness of medical devices. For clinical trials, manufacturers must conduct more detailed clinical evaluations for all products than before, often with their own clinical trials. A broader range of products must be tested by a conformity assessment body in order to enter the market. For certain high-risk products, an additional review of the conformity assessment by independent experts is prescribed.
- All medical products will now be registered in a central database (EUDAMED 3) and made publicly accessible. Registration by means of a Unique Device Identification (UDI) number will ensure unambiguous product information and traceability. Patients will now receive an implantation ID card.
- The requirements for market surveillance will be tightened. Cooperation between the monitoring authorities will be expanded and institutionalized.
- A comprehensive obligation for stakeholders to cooperate and provide information to the authorities is now introduced.
- The (risk) classification of medical devices is being revised. As a result, numerous medical devices are classified higher and are subject to stricter requirements.
- The term Medical Device Software ("MDSW") is clearly defined. This means that medical apps are considered medical devices under certain circumstances.
- The prohibition on benefits in the medical sector will now also apply to all medical devices from 2022. According to the so-called "integrity requirement", pecuniary advantages may not currently influence the prescription, use or dispensing of prescription medicines. The corresponding legal bases are found in the revised Therapeutic Products Act (TPA; SR 812.21) and in the newly introduced Ordinance on Integrity and Transparency in the Therapeutic Products Sector ("VITH"; SR 812.214.31), both of which entered into force on January 1, 2020.
In addition to the Therapeutic Products Act, the Human Research Act (HRA; SR 810.30) and the Medical Devices Ordinance (MedDO; SR SR 812.213) were also revised. In addition, a new ordinance on Clinical Trials with Medical Devices (KlinV-Mep; SR 810.306) was drafted. The entry into force of the new Ordinance for In-vitro Diagnostics (IVD) will finally follow in 2022.
III. Enactment
For reasons of coherence, the new provisions of medical device law in Switzerland will be brought into force gradually. The exemptions for the placing on the market and putting into service of medical devices that have not undergone a conformity assessment procedure already came into force on August 1, 2020.
However, the most important provisions, which concern, among other things, the requirements for market launch, market surveillance or the new requirements for clinical trials, did not enter into force until May 26, 2021.
Our specialized team will be happy to assist you in all legal matters relating to medical devices and is committed to supporting you in clarifying open questions in connection with the regulation of medical devices.
See also the update on the urgent need to update the Mutual Recognition Agreement (MRA) with the EU.
