Clinical Evaluations and the EU Market
Clinical evaluation is arguably one of the most important topics in the international medical device arena and the EU is no exception. As the EU regulations continue to be rolled out, albeit with a sliding timeline, industry and notified bodies are focusing on the interpretation and implementation of clinical information as it supports the end goal […]
FDA Third Party Review Programs
In August 1996, the FDA launched what was known as the Voluntary Third Party 510(k) Review Pilot Program. The program’s aim was to test out the usage of third parties for performing primary reviews of some medical devices under the 510(k) process in order to improve speed and efficiency. The limitation of the device eligibility was […]
The MHRA Roadmap: Navigating the UK Market
While the European Union (EU) remains hard at work in developing its new regulatory framework for medical devices under the MDR and IVDR, the UK has extended deadlines for the use of currently CE-marked medical devices to be sold in Great Britain (GB) and provided information on transition timelines. Under this transition: Additionally, self-declared CE-marked […]
