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 …
MDD & MDR Dates Let’s start with a quick summary of important MDD and MDR dates & timelines. As you surely already know, after being postponed for a year due to the Covid pandemic, the MDR is applicable from 26 …
1. Read & understand Medical Device Regulation (MDR) – This is the most critical advice we can give. You should read MDR to know what clinical evaluation is and what is required from you. There are no shortcuts on this …
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 …
FROM SETTING THE GOAL TO THE LITERATURE SEARCH AND REVIEW PROTOCOL In the forthcoming three part blog series, we would like to shed more light on the Literature Review process in accordance with the Medical Device Regulation (MDR). In today’s …
We are delighted to welcome Jelena, our new full-time employee. Jelena has unique expertise combining extensive working experience as a Legal Analyst and a Scientific Literature Librarian. Jelena will work on writing literature protocols and reports for the MDR Clinical …
AUTHOR Daniel Albahari, CEO & Principal Regulatory Consultant, BioReg Services, Israel. KEYWORDS EU Medical Device Regulation; MDR; MedTech; Non-medical devices; Annex XVI; Clinical evaluation; Post-market surveillance; Risk management. ABSTRACT In this article, we explore a newly introduced product category described …
As manufacturers of medical devices and sponsors struggle to meet MDR conformity, a second MDR amendment published at the end of 2019 may benefit some EU device manufacturers. In this blog we want to summarize what the MDR grace period …
We think it could. Final guidance for FDA “Breakthrough Devices Program” was published in December 2018. As this could be potentially relevant for many medical devices in development, we thought it would be worthwhile bringing it to your attention. Ultimately, …