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…
Notified bodies use a clinical evaluation assessment report (CEAR) to clearly document the conclusions of its assessment of the clinical evidence presented by medical device manufacturers in clinical evaluation reports (CERs) and associated documentation. The assessment of clinical evidence is a core requirement of the Medical Device Regulation (MDR, 2017/745). Use of a harmonised CEAR…
Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a wholly owned company in the US State of Massachusetts, Donawa Lifescience Inc., to promote its Clinical Research Organisation activities to both its existing and potential North American clients. Donawa Lifescience Inc., together with…
