Donawa Lifescience is pleased to inform its clients that in relation to travel restrictions during the coronavirus pandemic, our Clinical Department has implemented an efficient procedure for remote monitoring visits. European harmonized standards for clinical studies with medical devices or in vitro diagnostics, as well as the US Food and Drug Administration allow and, in…
Donawa Lifescience is actively working with in vitro diagnostic (IVD) medical device companies seeking to achieve the CE mark for COVID-19 diagnostic kits. We have most recently assisted a company in obtaining ethics committee approval for a clinical study of a new IVD to detect SARs Cov-2. The study will take place in the north…
We would like to advise clients that the Donawa team in our Rome office is fully operational. We have implemented a fast smart-work connection that allows employees to work from home, should this be necessary, although the office will remain open as some of us live close. With regard to associates who work on projects…
On February 2018, FDA published a final rule updating its regulations on the acceptance of clinical data generated outside or inside the US, which are intended to support any type of medical device FDA application or submission. A previous article discussed the proposed rule. This article will provide an overview of the updated regulations…
The NANDO website for the In Vitro Diagnostics Regulation (IVDR, 2017/746) has at long last reported an increase in the number of notified bodies designated to act under this regulation, from three to four. The latest addition is TÜV SÜD Product Service GmbH Zertifizierstellen, Germany, notified body reference number 0123. Although the date of application…
The European Commission website page devoted to EUDAMED has now been updated to provide information on when the first modules of the system needed to support the new device regulations will be available for the various actors to use on a voluntary basis. The webpage explains that: The development and implementation of EUDAMED is a…
