In the press

2022 was quite the year. While the pandemic slowly fizzled, medical device companies and medical writers enjoyed new guidelines and regulations, first-row seats to the biggest recall in FDA history, and a bunch of odd [...]

The In Vitro Diagnostic Regulation (IVDR; 2017/746) started its staggered implementation in May 2022. Compared to the In Vitro Diagnostic Directive (IVDD; 98/79/EC), post-market surveillance and vigilance have been given their due in the IVDR; [...]