Important contents of the Contingency MedDO
The Contingency MedDO provides transitional periods for the appointment of a Swiss representative!
Here is the source Brancheninformation_MDR_eMepV_EN.pdf.
MDSS is actively monitoring the situation in order to adapt quickly and provide a solution for our customers. We will let our customers know as soon as we have more information.
Previous News & Views - 2021.03.15
The Swiss situation is now being called "Swixit". It refers to the possibility of Switzerland not being able to join the single Market of the EU with medical devices.
We would like to conduct a survey to understand which of our clients would need a Swiss Representative. Help us serve you better by filling out the form MDSS survey.
The reason is that a higher level agreement with the EU is not being ratified by the Swiss Parliament. As long as this agreement is not in place, no Mutual Recognition Agreement (MRA) is going to be updated. Every time an EU law is being updated, Switzerland may be left out. The medical device industry is the first one to suffer from this due to the MDR. The MRA for medical devices refers only to the MDD and in order to cover the MDR it must be updated.
The EU is very clear! The EU will not update any MRAs as long as this higher level agreement is not in place. A good source of information on this topic can be found with the Swiss industry association. Here is a link to a webinar, which outlines the difficulties in detail.
MDSS will apply its best efforts to implement a Swiss Representative. Preparation work has started but the path to follow will depend on the update of the law in April.
We know that this is coming on a short notice, just like Brexit did. However, also there, we have proven we can handle this type of events successfully!