by In2Pharma | Jul 2, 2024 | News
The Netherlands In 2021, the EU-regulations for medical devices regarding safety and efficacy have become more strict under the implementation of the MDR. This implies that some CE labels have to be updated and a selection of medical devices now need a CE-label, while...
by In2Pharma | Jun 25, 2024 | News
Europe On the 21st of May, a new revision of the guidance on medical devices for applicants, marketing authorisation holders and notified bodies has been published. This document provides regulatory and procedural guidance on the implementation of the medical devices...
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...
