Practical 510(k) vs PMA vs De Novo FDA Pathway Guide
Practical 510(k) vs PMA vs De Novo guidance for choosing an FDA device pathway based on classification, predicates, risk, and evidence needs
Build a Defensible Clinical Evidence Strategy Under EU MDR
Build a defensible clinical evidence strategy under MDR Annex XIV, from the clinical evaluation plan to PMCF and notified body review.
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
EMA’s advice on managing the impact of the war in Ukraine
EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war in Ukraine is affecting clinical trials. Sponsors have asked for guidance on how to handle the situation [...]
EMA publishes Updated Version of Good Clinical Practice (GCP) Q&A
The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of questions and answers on GCP, as discussed and agreed by the GCP Inspectors [...]
Spain: AEPD Approves 1st Industry Code of Conduct to Enable Compliance with the GDPR
The Spanish Data Protection Authority (AEPD) has recently approved the first industry code of conduct (CoC) under the General Data Protection Regulation (GDPR). The CoC has been promoted by Farmaindustria (the National Business Association of the Pharmaceutical Industry) and [...]
US: FDA guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes
The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to request additional review of CDRH employees’ decisions or actions. It is intended only to [...]
UK: MHRA published guidance on clinical trial risk assessment, oversight and monitoring activities.
The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published guidance on clinical trial risk assessments, oversight and monitoring activities in two documents. It aims to assist sponsors and those conducting trials on implementing adequate oversight and monitoring [...]
