by In2Pharma | Jul 10, 2024 | News
Europe Extension of the IVD Regulation Transitional Periods Brussels, 30 May 2024 – The EU co-legislators have adopted an amendment to the In Vitro Diagnostics and Medical Devices Regulations (IVDR and MDR), extending the IVDR transitional provisions and adding a...
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 | Jun 11, 2021 | News
Europe The Commission has published a notice to stakeholders informing them that the mutual recognition and related trade facilitating effects for medical devices between the EU and Switzerland ceased to apply on 26 May. This is linked to the...
by In2Pharma | Jun 11, 2021 | News
Europe Regulation (EU) 2017/745 on medical devices is applicable in the European Union as of 26 May 2021. The Medical Device Regulation (MDR), was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and...
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...
