Check Out Our Latest Interview!
Our head of Regulatory Ed Drower was just recently interviewed on the Easy Medical Device Podcast to discuss MDR Literature Search best practices and other research topics.
Latest Publications
Look here for Industry updates and technical tutorials written by the CiteMed staff. All things Medical Device Regulation are covered in our publications.
6 Clinical Evaluation Report Mistakes and How to Avoid Them
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 [...]
CER Checklist: 12 Attributes of an Excellent CER Writer to meet the Clinical Evaluation Requirements
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 [...]
IVDR: State-of-the-Art for In Vitro Diagnostic Medical Devices
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 [...]
Your Medical Device Got CE Marked – Now What?
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 [...]
EU IVDR Regulation: A Brief
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 [...]
EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions
The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for the in vitro diagnostic regulation. While the medical device regulation did not [...]