Look here for Industry updates and technical tutorials written by the CiteMed staff. All things Medical Device Regulation are covered in our publications.
The Delay of EU MDR - What It Means For Your Medical Devices With the global COVID-19 pandemic disrupting industries, stakeholders in the medical devices industry have rapidly diverted efforts from the short-term urgency [...]
EU MDR Clinical Evaluation Requirements - Understanding the CER A critical component of the Technical File Submission for the CE Marking /conformity assessment process, Clinical Evaluation Reports are essential to sell or distribute medical devices in [...]
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its [...]