2 ms·
I still wonder who enforces the MDR if a company from outside the EU offers their app/software to EU citizens without any certification. There are quite a few
by WA 3y ago
I still wonder who enforces the MDR if a company from outside the EU offers their app/software to EU citizens without any certification.
There are quite a few health apps that are considered medical devices under MDR, but not in other countries. The EU companies must comply with the regulations, but nobody seems to be responsible for removing non-certified apps made by non-EU companies. That is a huge competitive disadvantage for EU companies.