EU MDR

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 [...]

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 [...]

Medical writing is hard. It's tricky, technical, and sometimes exceptionally tedious. Suppose you chose literature reviews as your niche or form part of the regulatory staff selected for clinical evaluations. In that case, I'm sure [...]

The clinical evaluation report (CER) is crucial for medical device approval in most countries. It is a comprehensive report summarising the device's safety, performance, and effectiveness based on clinical data. The CER plays a vital [...]

The European Union Medical Device Regulation (EU MDR) has set higher standards for medical device clinical evaluation ERs) standards. With stricter regulations and guidelines, clinical evaluation report writing requires expertise, experience, and knowledge of the [...]

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 [...]

IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the regulatory authority. The PIP breast implant scandal brought to light weaknesses in the overall regulatory [...]

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. [...]