The requirements for demonstration of safety and efficacy/performance by providing clinical evidence have increased in recent years. With the application of Regulations (EU) 2017/745 and 2017/746, manufacturers are expected not just to prepare a report but to implement a full process for the assessment of clinical data. Read our latest article by Magdalena Brendel Rizzo and Kivia Pontes de Oliveira published in the Journal of Medical Device Regulation.
Make sure your IVD complies with the IVDR requirements so it can remain on the market after the transition period ends on May 26, 2022.Learn more
Learn more about two of the most common challenges for IVD manufacturers in meeting IVDR compliance: performance evaluation and post-market requirements.Learn more
Before placing in vitro diagnostic (IVD) devices on the market, most manufacturers will need their technical documentation assessed by a notified body.Learn more