Switzerland has adapted its medical devices regulations to the new EU rules in the interests of patient safety and EU market access for the Swiss medical devices industry. The changes will also have implications for human research legislation.
What are medical devices?
Items as varied as plasters, hospital beds, cardiac pacemakers, disinfectants and x-ray equipment, have one thing in common: They are all medical devices. In other words, they are products “which are intended to have, or are presented as having, a medical use and whose principal effect is not obtained with a medicinal product” (Therapeutic Products Act, TPA, Art. 4 let. b).
As a result of the new EU rulings, products that are used without a medical purpose will be considered to be medical devices if they are used as such or are associated with similar risks, for example coloured contact lenses that do not correct vision.
New EU Regulation on Medical Devices
In 2012 the EU Commission presented for discussion a draft for new, stricter rules for medical devices. This had been prompted by various serious incidents – for example flawed silicone breast implants or defective hip implants.
In 2017 the EU finally approved two new regulations, one on medical devices (MDR) and one on in vitro diagnostic devices (IVDR). These have been coming into force in stages since 26 November 2017.
You can find more information about these regulations and the changes to Swiss law on the website on the Therapeutic Products Act (TPA). This is the law mainly affected by these changes.
Better quality assurance for medical devices
The new rules are primarily designed to better protect patients from defective medical devices. Consequently, manufacturers will, in future, have to submit stronger scientific evidence to substantiate the safety and quality of their devices before being allowed to place them on the market. They will also have to continue recording data after market launch. This explains why Switzerland is also adapting the laws and ordinances relating to human research as part of the revision of the TPA. Due to the Covid-19 pandemic, the amended rules will enter into force in May 2021, one year later than planned, at the same time as the MDR.
EU rules affect the law on human research and its implementation
Switzerland and the EU pursue the same objectives when it comes to regulating research:
- Protect affected persons
- Quality and transparency of research
- A regulatory environment that is as favourable to research as possible
The EU embodies these objectives in the context of market access to medical devices, whereas the HRA regulates the research independently of market access. There is a need for action at implementation level: the cantonal ethics committees and Swissmedic implement the procedures for approving and reviewing research projects with medical devices. They will now have to adapt and, in some cases, reorganise these procedures.
Certain EU definitions are now incorporated into Swiss law. For example, the definition of a "clinical trial" with a medical device now corresponds to the definition of a "clinical investigation" in the MDR. The categorization of individual research projects also changes. The transparency requirements of the MDR go further than in Switzerland, especially with regard to the documents of the approval procedure and the publication of the research results.
New ordinance on clinical trials with medical devices
The new definitions in the EU rules has prompted the Federal Council to propose a new “Ordinance on clinical trials with medical devices (ClinO-MD)”. The ClinO-MD will conveniently list in one legal text all the provisions relating to research with medical devices.
The consultation for the amended ordinance took place from 15 May to 5 September 2019.
The amended human research regulations were scheduled to enter into force in May 2020, but have been postponed to May 26, 2021 as a result of the Covid 19 pandemic.
Consultation on the inclusion of clinical trials with in vitro diagnostics (IVDs) in the ClinO-MD
For the time being, research with IVDs is still regulated in the ClinO. It is to be moved to the ClinO-MD at the same time as the planned start of validity of the IVDR on 26 May, 2022.
The public consultation on the amending decree of the ClinO-MD, with which research with IVDs is to be aligned with the rules of the IVDR, was opened on 14 April 2021 and lasted until 14 July 2021. You can find more information on this on the website on the Therapeutic Products Act (TPA).
Implementation of the regulations in the European Union
The FOPH is actively monitoring developments in the European Union regarding the EU regulations on medical devices. Starting in August 2019, the FOPH will publish regular updates on the implementation of the regulations in the EU and its member states. The reports will appear in English and can be found under the heading ‘Documents’.
Further information on the implementation of ClinO-MD
On the website of the Coordination Office for Research on Human Beings, you will find further up-to-date information on the new ordinance ClinO-MD and the current status of its implementation in Switzerland. The websites of Swissmedic and swissethics provide up-to-date practical information on applications for clinical trials with medical devices.
Draft Ordinance on Clinical Trials with Medical Devices (ClinO-MD) - not legally valid (PDF, 362 kB, 28.06.2021)Available in German, French or Italian
Explanatory report to the draft ClinO-MD (PDF, 1 MB, 14.05.2021)Available in German, French and Italian
Last modification 15.09.2021