Revision of medical devices legislation

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.

EU developments

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 European Council on 7 March 2017 and by the European Parliament on 5 April 2017, and came into force on 26 May 2017. After the various transition periods, comprehensive application will be mandatory. The first elements have been applicable since 26 November 2017 and concern the conformity assessment bodies (Notified Bodies) as well as the establishment of 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 July 2020

Swiss legislation on medical devices is being amended in phases, 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 Notified Bodies according to the new regulations from 26 November 2017. It enables Swissmedic to participate in the EU expert groups that are to be created.

The partial revision of the Therapeutic Products Act (TPA) and the Human Research Act (HRA) establishes the necessary legal basis in order to adapt the implementing legislation – specifically the completely revised MedDO, a new ordinance on clinical trials for medical devices (ClinO-MD) and the implementing provisions for in vitro diagnostics – to the new EU Medical Device Regulation. 

The modifications to the TPA and HRA adopted by the Parliament on 22 March 2019 were originally scheduled to come into force together with the regulations on 26 May 2020. In connection with the COVID-19 pandemic, the European Commission announced on 25 March 2020 that the full implementation of the MDR would be deferred by one year. This proposal was adopted by the EU Parliament on 17 April 2020 and by the EU Council on 24 April 2020.

For reasons of coherence, the new provisions will be implemented in Switzerland in stages. The derogations for the placing on the market and putting into service of medical devices that have not undergone a conformity assessment procedure will come into force on 1 August 2020. This makes it also possible, if in the interest of public health, to allow the placing on the market and putting into service of medical devices without conformity assessment. The main provisions concerning, inter alia, market introduction requirements, market surveillance or new clinical trial requirements will enter into force on 26 May 2021.

The in vitro diagnostic medical devices provisions will be included in a separate regulation. The date of entry into force remains unchanged at 26 May 2022, and consultation on the implementing legislation is planned for summer 2021.

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.

Documents

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):

Legislation

Medicinal products and medical devices legislation

The legislation on therapeutic products comprises the Federal Act on Medicinal Products and Medical Devices (TPA) and the associated ordinances. It is regularly aligned to the state of scientific and technical knowledge.

Further information

New regulations for clinical trials of medical devices

Switzerland is adapting its medical devices regulations to the new EU rules. This will have implications for the legislation on human research.

Last modification 30.06.2020

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Contact

Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003 Berne
Switzerland
Tel. +41 58 463 51 54
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