There is continuing doubt about the outcome of the Institutional Agreement (InstA) Switzerland negotiated with the EU. Hence, the advice from Switzerland’s Medtech industry association is to begin considering preparing… Read More
Month: April 2019
Draft Policy on Remaining Shelf-Life for Medical Products
The World Health Organisation (WHO) was looking for feedback from stakeholders on a draft policy which gives details of how medical devices, diagnostics and other medical products should be managed… Read More
Updated Clinical Evaluation Guidance on Comparability
In an effort to bring its guidance documents on clinical evaluation up to date, the International Medical Device Regulators Forum (IMDRF) has asked for feedback on proposed revisions to three… Read More
Device Registration and Legacy Devices
The European Commission’s Medical Devices Coordination Group (MDCG) recently published two guidance documents on timelines for device registration and on registration expectations for manufacturers of legacy devices. Legacy devices in… Read More