Latest Publications

While post-market clinical follow-up (PMCF) played a part in the MDD (Directive 93/42/EEC), the updated Medical Device Regulation (MDR, 2017/745) introduced stricter rules for post-market surveillance, including post-market clinical follow-up. The increase in clinical [...]

Until January 2021, medical devices in the UK were regulated under the European regulatory framework. After Brexit and the withdrawal of the UK from the EU, the UK government has had to put a full [...]

The MDR is a sweeping reform of medical device regulation in Europe that aims to strengthen safety and quality. Recently, the provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVD) have [...]

Post-market surveillance is a significant part of any medical device manufacturer's responsibilities, especially since the European Medical Device Regulation (MDR, 2017/745) implementation put an extra focus on post-market surveillance and vigilance activities. Today we are [...]

The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019 9 update published by the EU comes with some new rules for the [...]

The Medical Device Regulation (MDR) has been a regulatory framework since 2017. The MDR is designed to ensure that medical devices are safe, effective, and high-quality.   While the EU had given time for [...]

  We've explored post-market surveillance (PMS) for medical device manufacturers many times, for example, in our articles on post-market surveillance under the MDR, MDR post-market surveillance compared to the IVDR, and the relationships between [...]

May 26, 2022, marks the start of the 5-year staggered implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746). Unlike the In Vitro Diagnostic Directive (98/79/EC), the IVDR emphasizes continuous lifecycle management of [...]

A literature search is a systematic search through existing data in an organized way to determine an extensive range of quality references to a specific subject.   Literature searches serve many functions for a medical [...]

The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for medical device manufacturers commercializing their devices in the European Union. For manufacturers of higher-risk devices (Class IIa, Class IIb, and [...]

The short answer is, yes, it can be. MDR compliance may not have been expensive in the past, but as the regulations are changing, so is the cost to follow them. The new rules [...]

The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are two sides of the same regulatory coin in almost all aspects: both regulations seek to set up a regulatory system [...]