Miscellaneous

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 [...]

Adverse Events in Europe The landscape of medical device safety in Europe is significantly influenced by the occurrence and management of adverse events. An adverse event in this context refers to any untoward medical [...]

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, [...]

Obtaining the CE mark is one of the most significant milestones in the life of most medical devices. Unfortunately, it typically takes years and can exhaust even the most determined regulatory personnel. Nevertheless, getting [...]

The medical device development process is not a one-step operation. Instead, it is a multi-phase process requiring meticulous planning and implementation so that you get a safe and effective device at the end of [...]

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 [...]

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 [...]

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 [...]

EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the Technical File Submission for the CE Marking /conformity assessment process is that clinical evaluation reports are essential to selling or [...]

Clinical trials are important. The discovery of any new medical treatments is a standard step for testing the device on human subjects in a safe, controlled environment where the results and process can be [...]

Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness of your product is the first step of proving its quality attributes. [...]

With the updates to the European Medical Device and In Vitro Diagnostic Device Regulations (MDR 2017/745 and IVDR 2017/746, respectively), the requirements for clinical evidence were increased by the regulatory authorities. 1 Part of [...]