EU MDR

Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is essential to the clinical evaluation process for medical devices. The clinical evaluation [...]

Are you shopping for CER writers? Or perhaps trying to evaluate if this is the type of document you can make work yourself? Then this article is for you. With the transition to [...]

The medical device industry has been changing bit by bit every day, and one of the significant changes is the addition of technology to medical devices. While medical testing devices, scans, and robotic surgical [...]

Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market surveillance and vigilance system requirements for medical device manufacturers compared to previous regulations. [...]

UK MDR is the primary standard that mandates requirements for anyone selling medical products in the UK, as it is a vast market that often goes unexplored. After the UK left European Union, there [...]

2022 was quite the year. While the pandemic slowly fizzled, medical device companies and medical writers enjoyed new guidelines and regulations, first-row seats to the biggest recall in FDA history, and a bunch of odd [...]

A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the safety evaluation of a medical device product.   Literature reviews are essential [...]

Writing a clinical evaluation report compliant with the European Medical Device Regulation (MDR; 2017/745) can be challenging.   Ever stricter requirements for clinical evidence, data appraisal, and literature search processes have caused many medical [...]

The In Vitro Diagnostic Regulation (IVDR; 2017/746) started its staggered implementation in May 2022. Compared to the In Vitro Diagnostic Directive (IVDD; 98/79/EC), post-market surveillance and vigilance have been given their due in the IVDR; [...]

The purpose of vigilance is to protect the health and safety of patients, healthcare professionals, and other users by reducing the probability of reoccurring serious incidents related to in vitro diagnostic medical devices. For that [...]

The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed on the market. In these activities, the national regulatory authorities put measures [...]

It's not enough to make a device and put it on the market—you must know how people use your product. Therefore, the post-market surveillance must cover all devices that have been placed on the market, [...]