The new rules on in vitro diagnostic medical devices bring EU legislation in line with technological progress and advances in medical science. At the same time, by harmonising the conditions for access to EU markets, fair market access for all manufacturers is ensured.
"Today we are taking a big step forward for patients and the EU diagnostics industry" said Health Commissioner Stella Kyriakidou.
"The coronavirus pandemic has highlighted the importance of accurate and safe diagnosis and setting stricter rules is crucial to ensure that such diagnostic tools are made available to EU patients," she added.
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