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COMPANY NEWS

Donawa Lifescience opens GB company to provide UKRP services

Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a company in Great Britain (GB), Donawa Lifescience Ltd., to provide non-UK companies with ‘United Kingdom Responsible Person’ (UKRP) services as an easy initial pathway to the post-Brexit medical device market in Great Britain. Following the publication of the UK Medicines and…

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…

Global News

Guidance on when EU importers and distributors become manufacturers published

The EC Medical Device Coordination Group (MDCG) has published a new guidance clarifying the requirements of Article 16 of the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746) relating to the circumstances under which EU importers and distributors of medical devices may be regulated as manufacturers. The guidance, MDCG 2021-26, ‘Questions…

Ad hoc task-force report on legacy device transition endorsed by MDCG

An ad hoc task force of the EC Medical Device Coordination Group (MDCG) recently issued a report to the group clarifying many aspects of which transitional provisions in Article 120 of the Medical Device Regulation (MDR, 2017/745) would apply to so-called ‘legacy devices’. The report recommended that the MDCG accept the report as written and…

Italy now has six notified bodies

Italy has added another notified body (NB) to those now designated to operate under the EU Medical Devices Regulation (MDR, 2017/745), making a total of 24 available for use by device manufacturers, according to the NANDO website. Milan-based Certiquality, NB reference number 0546, is the latest to be added to the list of NBs designated…

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