Swiss Medical Devices Regulation Revision
A revision of the Medical Devices Ordinance (MedDO) has been approved by the Swiss Federal Council. This revision will take effect on 26th May 2021, along with a new Ordinance on Clinical Trials for Medical Devices (ClinO-MED). The aim of this revision is to align and harmonize it with the European Union Medical Devices Regulation (MDR) and consequently simplify market trading and maintain Switzerland’s market participation.
Liliana Teles

Liliana Teles

Regulatory Affairs Manager

Switzerland approves MedDO revision and moves toward MDR harmonization

Since 1st January 2002, the Medical Devices Ordinance (MedDO) has been in force in Switzerland. This Ordinance includes the Medical Devices Directive (93/42/EEC – MDD), the Active Implantable Medical Devices Directive (90/385/EEC – AIMDD) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC – IVDD). In this way, the European Directives on active implants, classical and in vitro diagnostic medical devices were incorporated into Swiss law.

Switzerland is integrated into the European market surveillance system and the European internal market for medical devices. A prerequisite for the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) is the equivalence of relevant legal requirements.

The new EU regulations on medical devices seek to improve the quality and safety of medical devices and consequently patient safety. For example, these regulations set up stricter criteria for the companies and defend that data should be made available to the public (in an understandable form) in a centralized European database for medical devices (EUDAMED).

The Swiss Federal Council has approved revision to MedDO in order to adapt its legislation on medical devices in line with developments in the EU. Switzerland wants to ensure that Swiss patients can also benefit from the planned improvements in patient safety and from the new transparency on the sector of medical devices. In sum, Switzerland wants to align and harmonize its legislation with the EU Medical Devices Regulation (MDR) and ensure its continuous participation as an equal partner in the European internal market for medical devices.

Originally, this revision would take effect on 26th May 2020, along with a new Ordinance on Clinical Trials for Medical Devices (ClinO-MED). The European Commission has announced that the full implementation of the MDR would be deferred by one year and as a result Switzerland has also set a new date (26th May 2021).

Switzerland has also approved an amendment to MedDO, which establishes derogation for the placing on the market and putting into service of medical devices that have not undergone a conformity assessment procedure. This amendment will come into force on 1st August 2020.

The harmonisation of the Regulation concerning in vitro medical devices with the EU In-Vitro Diagnostics Medical Device Regulation (IVDR) is yet to be approved and it will be included in a separate Regulation. The date of entry in force remains unchanged at 26th May 2022 and consultation on the legislation is planned for summer 2021.

References:

  1. Swiss Federal Council – 812.213 Medical Devices Ordinance of 17 October 2001 (MedDO). Available at: https://www.admin.ch/opc/en/classified-compilation/19995459/index.html
  2. Swiss Federal Council – Federal Office of Public Health FOPH – ‘Revision of medical devices legislation’ – Available at: https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html

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