Medical device manufacturers are constantly navigating the regulatory world. And like most other industries in 2022 and beyond, that world looks to be more complex and dynamic than ever. Particularly in the EU, UK, and US, change is unfolding at an unprecedented pace and with greater stakes as governing bodies envision and adjust to the … Continued
The United Kingdom (UK) officially left the European Union (EU) on 31 January 2020. According to the withdrawal agreement, it is now officially a third country to the EU and no longer participates in EU decision making. The agreement established a transition period that ended on 31 December 2020.1 As a result, the Medicines and … Continued
The European Commission (EC) officially published the EU In Vitro Diagnostic Regulation (IVDR) 2017/746 in the Official Journal of the European Union (OJEU) 05 May of 2017, which came into force on 25 May 2017. The deadline for compliance is 26 May 2022, and there has been no indication that it will be extended. Manufacturers … Continued
