Switzerland is adapting 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. The amended rules will enter into force in May 2020, 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.
Moreover, the EU definitions will now be incorporated in Swiss law, for example the term "clinical investigation" as defined in the MDR, as opposed to a "clinical trial" according to the HRA. A number of individual research projects will also be recategorised. The transparency requirements specified in the MDR go beyond those in Switzerland, particularly as regards the documents of the approval procedure as well as the publication of research results.
Switzerland and the EU intend to exchange data electronically on the review procedures for research with medical devices. This will require investment in the corresponding database systems. These new systems will help simplify the procedures for researchers and authorities and make them more transparent.
New ordinance on clinical trials with medical devices in the consultation process
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)”. Specifically, the definition of clinical investigation stated in the MDR covers both projects according to the Ordinance on Clinical Trials (ClinO) and those according to the Human Research Ordinance (HFV). The ClinO-MD will conveniently list in one legal text all the provisions relating to research with medical devices.
The consultation period for the amended ordinance runs from 15 May to 5 September 2019.
The amended human research regulations are scheduled to enter into force in May 2020.
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’.
Draft ordinance on clinical trials with medical devices (ClinO-MD) (PDF, 362 kB, 14.05.2019)Available in German, French or Italian
Explanatory report to the draft ClinO-MD (PDF, 1 MB, 14.05.2019)Available in German, French and Italian
Last modification 25.02.2020