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 [...]
July 13, 2023
Getting the long-awaited CE mark is certainly something to celebrate, so if you got it, congratulations! Now you just have to make sure to keep it! While the preparation for the device launch (which [...]
July 4, 2023
Requirements for post-market surveillance (among a host of other requirements for everything from classification to clinical follow-up) were never that elaborate in the In Vitro Diagnostics Directive (IVDD; 98/79/EC). However, with the introduction of [...]
June 27, 2023
A systematic literature review is one of the most important stages of the CER process, but it's also time-consuming and labor-intensive. Literature review software tools make the process a little easier by streamlining the [...]
June 20, 2023
The literature review is a critical part of any clinical evaluation. It's where you collect all of your clinical data, analyze it, weigh it, and use it to evaluate the acceptability of your device's risk-benefit [...]
June 13, 2023
The European Union Medical Device Regulation (EU MDR) is easily one of the major changes in the last decade that altered the medical device sector in the European Union. The goal was to improve [...]
May 23, 2023
Audits are not fun. That's general knowledge. Ask anyone, and they will tell you. But they will also tell you that being audited is a normal part of being in the industry. There are [...]
May 16, 2023
The European Medical Device Regulation (EU MDR, 2017/745) has been called many things since it was first drafted, some of which cannot be repeated here. One thing it has probably never been called is [...]
May 2, 2023
The clinical evaluation reports are the final transcript for medical devices. Allow us to explain. So, you know how in high school, you had to earn good grades and maintain a solid record to impress [...]
April 25, 2023
You want to sell your device in the European Union and start the CE marking process. But after reviewing the MDR and the guidance documentation, you begin to doubt the CE mark process. Are [...]