December 6, 2022
The In Vitro Diagnostic Regulation (IVDR; 2017/746) started its staggered implementation in May 2022. Compared to the In Vitro Diagnostic Directive (IVDD; 98/79/EC), post-market surveillance and vigilance have been given their due in the IVDR; [...]
July 5, 2022
Post-market surveillance is a significant part of any medical device manufacturer's responsibilities, especially since the European Medical Device Regulation (MDR, 2017/745) implementation put an extra [...]
June 28, 2022
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 [...]
April 18, 2023
Move over, Dr House, there's a new diagnostician in town, and it's not human! Thanks to the power of AI, medical devices are becoming smarter than ever, analyzing data faster than ever and creating regulatory [...]
April 11, 2023
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 [...]
April 4, 2023
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 [...]
March 28, 2023
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 [...]
March 21, 2023
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 [...]
February 28, 2023
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 [...]
February 22, 2023
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 [...]
February 21, 2023
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 [...]
February 18, 2023
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 [...]