To allow consultation among competent authorities (CAs) on borderline and classification issues concerning medical devices, and to ensure that appropriate guidance is published in the Manual on Borderline & Classification for Medical Devices (the Manual), the Borderline & Classification Working Group (BCWG) of the Medical Devices Coordination Group (MDCG) has updated the ‘Helsinki Procedure’ first…
The European Commission has published the September 2021 copy of its Newsletter for Medical Devices, copy obtainable from here. The Newsletter covers, among other topics: A webinar for patients Launch of a UDI Helpdesk Transitional provisions for IVD certification Q&A for specific combinations of medicinal products and medical devices Rules for Eudamed registration Identification numbers…
The UK government, via the Medicines and Healthcare products Regulatory Agency (MHRA) has now published its consultation on the future regulation of medical devices in the UK. The MHRA webpage introducing the consultation is available from here, and the consultation questionnaire itself is accessible here. As background, the current 2021 version of the 2002 device…
Donawa Lifescience President, Maria E. Donawa M.D., has authored a new White Paper for inclusion in BSI’s Compliance Navigator series, titled ‘Medical device clinical investigations – What’s new under the MDR?’ The 30 page document discusses the important new requirements for pre-market and post-market clinical investigations included in the European Medical Device Regulation (MDR, 2017/745),…
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…
