BioStock’s article series on MDR and IVDR: Notified Bodies – potential bottleneck 19 mars, 2021 With the introduction of MDR and IVDR, the regulatory landscape in the EU for medical devices is undergoing tremendous change. The new regulations are not only causing challenges for manufacturers of medical de... LÄS MER!
BioStock’s article series on MDR and IVDR: Key changes in IVDR 5 mars, 2021 The in vitro diagnostics industry is facing significant changes since a new regulatory framework, IVDR, is replacing the old directive, IVDD. The anticipated changes in the new regulation are likely to create a... LÄS MER!
BioStock’s article series on MDR and IVDR: Key changes in MDR 22 februari, 2021 This year, medical device manufacturers will be confronted with major changes since a new regulation for medical devices, MDR, will take effect in May 2021. The new regulation is an improved version of the old ... LÄS MER!
