MDR Compliance Timelines In this short blog we explain that MDR for Class I Medical Devices (Self-certified) is mandatory from 26 May 2021. In February 2023, the EU Commission extended the Notified Body (NB) certificates issued under the Medical Device …
What is MDR Clinical Evaluation? Medical Device Regulation (MDR) clinical evaluation is an ongoing procedure to collect, appraise and analyze clinical data on a medical device (or its equivalent) to conclude whether there is sufficient clinical evidence for compliance with …
FDA Form 483 Observations An FDA Form 483 is issued to the company after an inspection. This FDA Form 483 document includes the inspector’s observations and judgment regarding the conditions that may constitute violations of the Food Drug and Cosmetic …
Medical Device Regulation – MDR and PMS Requirements This article clarifies the primary post-market surveillance (PMS) elements and requirements according to Medical Device Regulation (MDR). Post-Market Surveillance: PMS is a collection of processes and activities used to monitor the performance …
New Israel Cosmetic Regulations On 18 October 2021, Israel Economics Committee has held a meeting that discussed and approved a new regulatory and importing policy for cosmetic products. A new cosmetic regulation is part of the government’s overall import reform …
What is a product significant change? The manufacturers should carefully read MDCG 2020-3 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR concerning devices covered by certificates according to MDD or AIMDD. As per Article 120 …
MDR Clinical Evaluation & Clinical Evaluation Report (CER) Clinical Evaluation In this article, we provide helpful advice on performing successful MDR clinical evaluation and writing a Clinical Evaluation Report in compliance with MDR. 1. Read & understand Medical Device Regulation …
Appraising and evaluating the search results In our previous blog, we focused on performing a successful database search and doing the first screening of search results through titles and abstracts. In this final, third part of our three-part series, we …
Performing a database search and an initial analysis of the search results In our previous blog we focused on understanding the goal of our literature search and on writing a good, solid literature search and review protocol. In this second …