The EU currently leads the way in regulatory standards, with the UK and Switzerland following suit. This is being done for valid reasons, as medical devices may not be available in these markets due to the same reasons. Overall, these are excellent news for the medical devices industry.
However, these countries may not want to rely heavily on the EU approval process. This situation could rapidly change in the future, particularly, as the UK will transition to its own law (with a transition period for CE marking) and with the UKRP in place, while Switzerland will accept FDA with the CH-REP in place. Once this happens, both countries will no longer depend on the EU for their supply of compliant medical devices.
While some may see this as a positive development, historically, different regulatory markets have been used to protect domestic industries, which has not been conducive to the overall prosperity of a region. It remains to be seen how this will play out in the medical device industry. Are we going to see protectionist measures in the future? Only time will tell.
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