More safety for medical devices - Consultation
The Confederation wants to increase the safety of medical devices and their subgroup of in vitro diagnostics (IVD) and improve patient safety. To this end, the Therapeutic Products Act is being revised step by step. The consultation on the new In Vitro Diagnostics Ordinance (IVDV) and the amendments to the Ordinance on Clinical Trials for Medical Devices was recently opened.
Around 500,000 different medical devices and in vitro diagnostics (IVDs) are currently in circulation in Switzerland and the European Economic Area. Following various incidents, for example with silicone breast implants or defective hip prostheses, the control mechanisms have been tightened throughout Europe. Switzerland has had regulations equivalent to those of the EU since 2001 and has also adapted its legal provisions in parallel with the EU. The aim is to ensure a regulated supply of safe and efficient medical devices in Switzerland for the better protection of Swiss patients.
In particular, the new regulations tighten the requirements for performance studies for IVDs, both in terms of safety and transparency. In addition, certain products in the highest risk classes will be reviewed by an independent international panel of experts. Manufacturers must continuously review the safety of products after they are launched on the market.
Adaptation of medical devices legislation
The adaptation of Swiss medical device legislation is taking place gradually and in coordination with the transition periods in the EU. The first stage was completed on 25 October 2017 with the adoption of the first revision of the Medical Devices Ordinance (MepV). In the second stage, on 22 March 2019, Parliament adopted the amendments to the Therapeutic Products Act and the Human Research Act. This was followed by the total revision of the MepV and a new Ordinance on Clinical Trials with Medical Devices (KlinV-Mep). With the IvDV, the provisions on in vitro diagnostics are to be adapted to the legal developments in the EU in a final stage. The revision is part of the federal government's master plan to strengthen biomedical research and technology.
Medical Devices
Medical devices cover a wide range of different products that can be used for medical, therapeutic or diagnostic purposes. These include not only implants, but also simple products such as adhesive plasters and spectacles. Also included in the subgroup of medical devices are laboratory tests for medical diagnosis, known as in vitro diagnostics. They have specific characteristics and are regulated in a separate In vitro Diagnostica Regulation (IvDV).
Press release Federal Government
Consultation on the ordinances (April 2021)
Draft of the In-vitro Diagnostics Ordinance (IvDV)
Draft amendments to the Ordinance on Clinical Trials with Medical Devices (KlinV-Mep)
