European Commission - Draft of Implementing Regulation open for comments
The European Commission's 'Have your say' portal has opened on its website the document „ Common specifications for in vitro diagnostic...
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Regulatory House
Feb 261 min read
EU rules for medical devices and in vitro diagnostics - public consultation
The European Commission is preparing a public consultation document for Q3 2024. This initiative aims to help the Commission assess...
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Regulatory House
Feb 221 min read
Recommendations of SÚKL for submitters of bioequivalence (BE) studies
Applicants for BE studies often do not include some of the required documents when submitting their application for accelerated study...
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