by In2Pharma | Mar 29, 2023 | News
Europe Due to lack of Notified Body (NB) capacity, lack of access to NB for SMEs, supply chain disruptions (Covid-19, Ukraine war,…),…the MDR implementation is creating bottlenecks in product certification. A new regulation ((EU) 2023/607) has been published, amending...
by In2Pharma | Feb 5, 2018 | News
The Netherlands The European Regulation for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) will fully apply in 2020 and 2022, respectively. This new regulation will have consequences for the marketing authorization of medical devices. The...
by In2Pharma | Apr 14, 2017 | News
EU Finally some progress! The final versions of the European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR, resp.) have finally been approved by the European Parliament on April 5th 2017. Formal publication of the MDR and IVDR in the Official...