December 13, 2022
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 [...]
July 19, 2022
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 [...]
July 12, 2022
The MDR is a sweeping reform of medical device regulation in Europe that aims to strengthen safety and quality. Recently, the provisions of Regulation [...]
December 14, 2022
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 [...]
December 13, 2022
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 [...]
December 6, 2022
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; [...]
November 15, 2022
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 [...]
November 8, 2022
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 [...]
November 1, 2022
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, [...]
October 25, 2022
In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by the European Parliament and Council, came into force. The regulation forms the core of European market surveillance law and will [...]
October 18, 2022
CE marking indicates compliance with an EU directive so that you can market your products in the EU. It's that simple. CE marking is a voluntary conformity assessment procedure, but it is a [...]
October 11, 2022
Even though every medical device manufacturer does their utmost to ensure their medical devices are safe and efficient, adverse events still happen. Off-label use, installation/service issues, lack of training, and many other causes can lead [...]