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 EU provisions.

Medical devices regulation in Switzerland

The Medical Devices Ordinance (MedDO) has been in force since 1 January 2002. The European directives on classical medical devices, active implants 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.

EU developments

Various incidents and scandals involving medical devices (e.g. leaky silicone breast implants, defective hip prostheses) raised doubts about the 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 replace the previous directives. The more effective regulations 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 in the EU. 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.

Amendments in Switzerland

Switzerland is adapting its medical devices legislation to the new EU rules. The aim of the revisions is to improve the quality and safety of medical devices for patients in Switzerland. The adaptation of Switzerland’s medical devices 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 (MedDO). In a second stage, on 22 March 2019, Parliament adopted the partial revision of the Therapeutic Products Act (TPA) and of the Human Research Act (HRA). This was followed by the total revision of the MedDO and a new ordinance on clinical trials for medical devices (ClinO-MD). The transition of the EU MDR into Swiss medical devices legislation is complete when these provi-sions enter into force on 26 May 2021.
In vitro diagnostic medical devices are considered a subgroup of medical devices. They have specific characteristics and are to be regulated in a final step in a separate ordinance on in vitro diagnostics (IvDO).
Alongside these legislative projects, the Agreement between the EU and Switzerland on mutual recognition in relation to conformity assessment (MRA) is also to be updated. This is an instrument to overcome technical barriers to trade for the marketing of numerous industrial goods between Switzerland and the EU. These goods also include medical devices. The Agreement covers over a quarter of all Swiss exports to the EU and over a third of all goods imported from the EU.

Focus on patient safety

The revision introduces significantly tighter requirements for all stakeholders. Thus, for example, manufacturers have to prove the usefulness and effectiveness of high-risk devices by means of clinical trials 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. At the same time, the requirements and responsibilities of the competent authorities and of conformity assessment bodies organised by the private sector will become substantially more far-reaching.

Situation as of May 2021

In the course of aligning Swiss medical devices legislation with the new EU Regulations MDR and IVDR, the MRA also needs to be updated in order to maintain facilitated reciprocal market access between Switzerland and the EU, and to be able to guarantee joint implementation. However, the European Commission is making the full update of the MRA subject to progress on the Institutional Agreement.

In order to mitigate the negative effects of a delayed update, measures have been prepared. At its meeting of 19 May 2021, the Federal Council approved the amending enactment to the fully revised MedDO, which will enter into force on 26 May 2021. These measures take balanced account of the aspects of maintaining the safety and effectiveness of medical devices to protect patients, reduce supply risks, preserve the attractiveness of the Swiss market to foreign manufacturers and ensure enforceability within the framework of market supervision.
Despite the uncertainty around the MRA update, the revision work should continue based on equivalent provisions to EU law. An update of the MRA should thus still be possible within the next 1-2 years. In particular this affects the drafting of the new IvDO and the amendments to the ClinO-MD.

On 14 April 2021, the Federal Council opened a consultation on the new Ordinance on In Vitro Diagnostics (IvDO) and the amendments to the Ordi-nance on Clinical Trials for Medical Devices (ClinO-MD), which will last until 14 September. The Federal Council will decide on the next steps in the area of in vitro diagnostics at a later stage, mindful of the progress made in updating the MRA.

Responsibilities

The FOPH adapts Swiss medical devices legislation on behalf of the Federal Department of Home Affairs. This is done in close collaboration with Swissmedic, the State Secretariat for Economic Affairs (SECO) and the Europe Division at the Federal Department of Foreign Affairs (FDFA).
The office responsible for the update is SECO, which is part of the Federal Department of Economic Affairs, Education and Research.

Documents

All documents are available in French, German and Italian only


Consultation on the new IvDO and amendment of the ClinO-MD (April 2021):

Consultation on the MedDO and ClinO-MD (May 2019):  

Parliamentary 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 14.05.2021

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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
E-mail

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