The IVDR in-house exemption and what it costs to rely on
How Article 5(5) of the IVDR allows a health institution to make and use its own in vitro diagnostic, and the nine conditions attached.
Tag: pathway
3 posts
EU routes to market for medical devices
How device class under Regulation (EU) 2017/745 sets the conformity assessment route, with the Annex IX, X and XI procedures and transitional deadlines.
Which FDA route a device qualifies for, 510(k), De Novo or PMA
How FDA premarket routes divide between 510(k), De Novo and PMA, with the criteria, contents and review timeframes set by 21 CFR parts 807 and 814.