A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the safety evaluation of a medical device product. Literature reviews are essential for manufacturers to ensure that the IVDR has been constructed according to current regulatory requirements and that it is based on [...]
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 writers to despair. The updates to the regulation are also causing problems for medical device manufacturers, who can no longer find [...]
Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can be tricky. Regulations and guidelines change, as does the attitude of the notified bodies. A clinical evaluation report (CER) that was compliant ten years ago might not pass conformity assessment today, even though clinical evaluation [...]
The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019 9 update published by the EU comes with some new rules for the manufacturer. Medical manufacturers will now have to submit a summary of safety and clinical performance (SSCP) for their products. This [...]
A year into the EU Medical Device Regulation (MDR 2017/745), it is safe to say the implementation of the MDR has been complicated, for both manufacturers and the notified bodies. Even though the European Parliament voted for a partial delay of the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) in December 2021, the implementation [...]
A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices. The objective of the literature search is to obtain information about the safety and performance attributes of similar products for which [...]
Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The EU MDR (2017/745) requires clinical evaluation and post-market surveillance programs to ensure the safety of medical devices throughout their lifetime. The clinical evaluation report and the periodic safety update report are critical [...]
Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer's job is not only to come up with a device that will be beneficial to the patient population, and hence will have a place in the target market, but also to ensure that the research regarding the [...]
Medical device manufacturers conduct clinical investigations to ensure that products meet the rules. To most, it is simply a necessity in order to get their medical devices approved. However, in some cases, the clinical evaluation plan needs to be more precise than others. The purpose of conducting a clinical study is to ensure [...]
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 conformity assessment procedures. Through the CEAR, the MDCG aims to standardize the documentation of the NBs’ assessment of manufacturers’ clinical [...]
