The Swiss Federal Office of Public Health (FOPH) has announced that their current medical device standard Medical Devices Ordinance (MedDO) will undergo revisions in order to reflect the EU’s adoption of the MDR and IVDR. Although Switzerland isn’t part of the European Union it bases its regulations around the EU rules in order to maintain access to the EU market.
The enforcement of the new EU MDR rules is thought to be a staged approach but ultimately tie in with the EU times lines, therefore this will come into force in Switzerland during 2020.
If you have any concerns regarding managing changing standards on a global scale the Instem team are always here to help. You can call us on +44 1785 825653 or email [email protected].