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COMPANY NEWS

Maria Donawa authors new White Paper for BSI Compliance Navigator

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 using remote monitoring during coronavirus pandemic

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 helping clients gain approval for COVID-19 diagnostic studies

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…

Global News

Multiple guidance documents issued for Eudamed ‘Actor Registration’

The European Commission has published a number of guidance documents related to how manufacturers, authorised representatives and importers (‘economic operators’) will be able to access and register with the ‘actor registration’ module of Eudamed from 1 December 2020. A new webpage has been set up within the Eudamed website, relating only to the actor registration…

MDR update

Progress has been made on several fronts in relation to the roll-out of regulations and guidance for the Medical Device Regulation (MDR, 2017/745) in recent weeks. Firstly, the 16th and 17th MDR Notified Bodies have been named on the NANDO database, these being DQS Medizinprodukte GmbH, Germany, making it the sixth Notified Body to be…

MHRA publishes information on UK post-Brexit device regs

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published in its website an overview of the post-Brexit regulations that will apply to medical devices in the event of a ‘no deal’ or ‘hard’ Brexit. It confirms that the UK will leave the European Union (EU) on 31 December 2020, and so the new…

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