International – 2019 in Review: All Eyes on MDR/IVDR, PRV Records and What’s Coming in 2020

As 2019 comes to a close, Focus takes a look back at what articles received the most attention as well as what to expect for the coming year.

MDR/IVDR

Six of the top 10 most-read articles this year were devoted to the incoming Medical Devices Regulation (MDR) in the EU, which has a deadline of 26 May 2020, and the In Vitro Diagnostic Regulation (IVDR), which is coming two years after MDR.

Last summer, the US urged the EU to push back the MDR deadline by three years, although the EU commissioner for health has since said the deadline is not going to change (beyond the four-year pushback for some Class I devices in the second corrigenda).

With the May deadline in mind, the designation of notified bodies (NBs) has also been of paramount concern for Focus readers, as the rollout of the designations has been slower than planned and as some NBs have decided to not pursue designation under MDR.

RAPS/KPMG survey unveiled in September also shows how device companies may not be ready for MDR, especially as the launch of the device database under MDR, known as Eudamed, was delayed by two years.

Meanwhile, the European Commission and Medical Device Coordination Group released several MDR guidance documents in 2019 on persons responsible for regulatory compliance and implant cardsClass I devicessampling and MDR codesclassifying softwaresafety and clinical performance summariestransitional provisionsunique device identifiers and more on what’s coming