Switzerland: Public Consultation on Draft of New In Vitro Di

Switzerland: Public Consultation on Draft of New In Vitro Diagnostic Ordinance


May 2021
Share
Since 2002, based on a mutual recognition agreement between the European Union (EU) and Switzerland (MRA), Swiss manufacturers of
in vitro diagnostic medical devices (IVD) are able to participate in the European single market for medical devices without having to overcome technical hurdles their EU competitors do not have to face, and vice versa. The basis for this mutual market access is the equivalence of the EU and Swiss regulations in the field of IVDs.
In 2017, the EU put into force its new regulations on medical devices and IVD. This development obligated the Swiss government to adapt the Swiss regulation accordingly in order not to put the MRA in jeopardy. In a first step, the Federal Counsel issued new Ordinances on Medical Devices (MDO) and on Clinical Research with Medical Devices (ClinO-MD) that will become applicable on May 26, 2021.

Related Keywords

Germany , Italy , Switzerland , France , French , Italian , German , Swiss , , European Union , Clinical Research , Federal Counsel , Medical Devices , Swiss Regulation , ஜெர்மனி , இத்தாலி , சுவிட்சர்லாந்து , பிரான்ஸ் , பிரஞ்சு , இத்தாலிய , ஜெர்மன் , சுவிஸ் , ஐரோப்பிய தொழிற்சங்கம் , மருத்துவ ஆராய்ச்சி , கூட்டாட்சியின் ஆலோசனை , மருத்துவ சாதனங்கள் ,

© 2025 Vimarsana