EU MDR

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 [...]

When one tries to publish in an international journal these days, they inevitably encounter an obstacle: researchers around the world have more than likely published thousands of papers on a similar topic, which could need [...]

A year into the EU Medical Device Regulation (MDR 2017/745), it is safe to say the implementation of the MDR has been complicated, for both manufacturers and the notified bodies. Even though the European Parliament [...]

A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices.   The [...]

Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The EU MDR (2017/745) requires clinical evaluation and post-market surveillance programs to ensure [...]