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News about GMP/cGMP

2017-11-29

Switzerland Revises Medical Devices Legislation

According to the Swiss Federal Office of Public Health FOPH, Switzerland is revising its medical devices legislation, closely modelled on the various new EU requirements aiming at an improvement on the safety and quality of medical devices.

 

The medical devices regulation in Switzerland goes back to January 2002. Since then it has been continuously adapted to the European standards. As of 15 April 2015, the requirements for the conformity assessment bodies have been increased along with the EU’s (“small MedDO revision”).

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 and the European internal market for medical devices. A prerequisite for the MRA is the equivalent nature of the relevant legal requirements in Switzerland and in the EU.

Current EU Status

On 5 April 2017, the two new EU Regulations on medical devices were adopted by the European Parliament:

  • Regulation (EU) 2017/745 on medical devices (MDR)
  • Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR).

These regulations replace the existing Medical Device Directives:

  • Directive on active implantable medical devices 90/385/EEC (AIMD)
  • Directive concerning medical devices 93/42/EEC (MDD)
  • Directive on in-vitro diagnostic medical devices 98/79/EEC (IVDD)

The new Regulations entered into force on 26 May 2017 and shall apply after graduated transitional periods, ranging from 6 months to 5 years, in Spring 2020 (MDR) or Spring 2022 (IVDR), respectively.

Current Swiss Status

The early revision of the Medical Devices Ordinance (MedDO) was adopted by the Swiss Federal Council on 25 October 2017 and covers all points arising from the new EU regulations that apply as of 26 November 2017. Taking these steps, Switzerland can continue to participate as an equal partner in the European internal market for medical devices. Swissmedic, by collaborating with the competent authorities of the EU Member States, can continue its effective and efficient market supervision of medical devices. For Swiss manufacturers, the access to the European internal market remains ensured. The complete revision of the MedDO and the new Ordinance for in vitro diagnostics takes account of all provisions of the EU regulations and is likewise scheduled to enter into force in the first half of 2020. Along with the actual legislation projects, updates to the MRA need to be negotiated by the Switzerland–EU Joint Committee in order to record mutual obligations between Switzerland and the EU at the international treaty level. Responsibility for this process lies with SECO.
Source:
Swiss Federal Office of Public Health
Medizinprodukteverordnung (MepV), Änderung vom 25.10.2017
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