Following a number of incidents, stricter control mechanisms for medical devices are being introduced throughout Europe. Switzerland is also revising its medical devices legislation, closely modelled on the various new EU provisions.
Medical devices regulation in Switzerland
The Medical Devices Ordinance (MedDO) has been in force since 1 January 2002. The European directives on active implants, classical and in vitro diagnostic medical devices were incorporated into Swiss law. Revisions were made on 1 April 2010 as part of the Therapeutic Products Ordinance Package III; they harmonised Swiss law with the EU’s revised medical devices directives, which have been in force since 21 March 2010. Requirements for conformity assessment bodies were brought in line with the EU’s tougher requirements with effect from 15 April 2015.
Additionally, through the agreement between Switzerland and the EU on the mutual recognition of conformity assessments (Mutual Recognition Agreement, MRA, chapter 4), Switzerland is integrated into the European market surveillance system and the European internal market for medical devices. A prerequisite for the MRA is equivalence between the relevant legal requirements in Switzerland and those in the EU.
Various events and scandals involving medical devices (e.g. leaky silicone breast implants, defective hip prostheses) raised doubts about the current surveillance system for medical devices in the EU. Consequently, the European Commission in 2012 introduced drafts for two regulations, for medical devices (Medical Devices Regulation, MDR) and in vitro diagnostics (In vitro Diagnostic Medical Devices Regulation, IVDR), which were intended to replace the previous directives. The more effective provisions at the regulation level were intended to improve the quality and safety of medical devices, harmonise implementation in the EU, and thereby improve patient safety.
Both regulations were adopted by the EU Council on 7 March 2017 and by the European Parliament on 5 April 2017. The regulations were published in the Official Journal of the EU on 5 May 2017 and came into force on the 26 May 2017. After their respective transition periods (up to 3 years for MDR, up to 5 years for IVDR), comprehensive application will be mandatory. The first elements apply from 26 November 2017 and concern the conformity assessment bodies (designated bodies) as well as establishing the Medical Device Coordination Group, MDCG, which will play a central role in the uniform implementation of the regulations.
Focus on patient safety
The aim of the new EU regulations is to improve the quality and safety of medical devices and thereby patient safety. With this in mind, the regulatory requirements for all stakeholders are significantly tightened. Thus, for example, manufacturers have to prove the usefulness and effectiveness of high-risk devices by means of clinical studies much more comprehensively than was previously the case. Stricter criteria for the approval and monitoring of clinical trials and performance testing have been introduced. In addition, the clear identification of all devices should enable their full traceability. Moreover, data should be made available to the public in an understandable form in a centralised European database for medical devices (Eudamed). At the same time, the requirements and responsibilities for the competent authorities and for conformity assessment bodies organised by the private sector will become substantially more far-reaching.
Consequences for Switzerland
Switzerland adapts its legislation on medical devices in line with developments in the EU. By doing so, Switzerland ensures that Swiss patients can also benefit from the planned improvements in patient safety and from the new transparency in information on medical devices. At the same time, Switzerland can continue to participate as an equal partner in the European internal market for medical devices. By collaborating with the competent authorities in the EU Member States, Swissmedic can continue its effective and efficient market supervision of medical devices. Swiss manufacturers continue to have access to the European internal market.
On behalf of the Federal Department of Home Affairs, the FOPH administers the amendments in the Swiss medical devices legislation. This will involve close collaboration with Swissmedic, the State Secretariat for Economic Affairs (SECO) and the Directorate for European Affairs (DEA).
Situation as of May 2019
Swiss legislation on medical devices is being amended gradually, in line with the transitional periods applicable in the EU Member States:
- The revision of the Medical Devices Ordinance (MedDO), which was brought forward to 25 October 2017, allows Swiss conformity assessment bodies to register as designated bodies according to the new regulations from 26 November 2017, and enables Swissmedic to participate in the EU expert groups that are to be created.
- Amendments to the Acts: The partial revision of the Therapeutic Products Act (TPA) and the Human Research Act (HRA) is intended to establish the necessary legal basis in order to be able to amend the implementing legislation (complete revision of the MedDO and implementing provisions for in vitro diagnostics) to new EU regulation on medical devices. On 30 November 2018, the Federal Council submitted the dispatch on amending the Therapeutic Products Act (new medical products regulation) to parliament. The matter came before parliament under a special procedure and was adopted on 22 March 2019. The amendments are scheduled to come into force in the first half of 2020.
- The complete revision of the MedDO and the implementing provisions on in vitro diagnostics take account of all provisions of the EU regulations and are likewise scheduled to come into force in the first half of 2020 and in 2022, respectively. On 15 May 2019 the Federal Council opened the consultation regarding the complete revision of the MedDO and the new ordinance on clinical studies for medical devices. The consultation procedure will last until 5 September 2019.
- Adjustment of the MRA (chapter 4): Alongside the actual legislation projects, updates to the MRA need to be negotiated by the Switzerland‑EU Joint Committee in order to introduce mutual obligations for Switzerland and the EU at international treaty level. Responsibility for this process lies with SECO.
All documents are available only in French, German and Italian
Consultation for the ordinances (May 2019):
Parliamentarian phase (winter 2018/2019)
Consultation for the revision of the Medical Devices Law (March 2018):
Last modification 14.11.2019