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…
The European Commission has launched a new Medical Devices website, hosted on the portal of the Directorate-General for Health and Food Safety (DG SANTE). The website contains information and advice for all stakeholders in the medical devices and in vitro medical devices value chain with respect to their roles and responsibilities within the context of…
Five distinct device types will no longer require premarket notification (510(k)s) to the US Food and Drug Administration (FDA) according to a final order issued by the agency. The following five device types were identified in the 22 July 2020 edition of the Federal Register: Assisted reproduction accessories (assisted reproduction laminar flow workstations); Reproductive media…
Following two failed attempts to have its standards mandate for the Medical Devices Regulation (MDR, 2017/745) accepted by the European standards bodies CEN and CENELEC, the European Commission has indicated that a third mandate will be issued during the first quarter of 2021. The new date has been included in the recently updated Joint Implementation…
