by In2Pharma | Sep 3, 2021 | News
Europe EMA published a guideline, effective from 1 January 2022, on quality documentation for medicinal products when used with a medical device (first version). The guideline describes the information that should be presented in the Quality part of a MA dossier for a...
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 | Jun 9, 2021 | News
Europe The Unique Device Identification (UDI) System has been introduced under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) which apply respectively as from 26 May 2021 and 26 May 2022. The...
by In2Pharma | Nov 22, 2019 | News
The Netherlands Starting from 26 May 2020 the ‘College ter Beoordeling van Geneesmiddelen (CBG)’ will be giving advice according to the new Medical Device Regulation (MDR, EU 2017/745). Starting from 1 December 2019, the CBG only handles requests for consultation...
