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…
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…
One month after members of the European Council expressed support for delaying the Medical Device Regulation (MDR, 2017/745) transition period in a meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), the European Commission on 6 January 2023 adopted a proposal to allow medical device manufacturers more time to complete certification of…
The European Commission issued new guidance documents in December 2022 relating to both the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostic Regulation (IVDR, 2017/746), as follows: MDCG 2022-19: Performance study application/notification documents under Regulation (EU) 2017/746 MDCG 2022-20: Substantial modification of performance study under Regulation (EU) 2017/746 MDCG 2022-4 rev.1: Guidance on…
Maggie Fick, a reporter with Reuters.com, published an article titled ‘Medical device makers drop products as EU law sows chaos’ on 19 December 2022, commenting, quite accurately “A law created to stop one criminal company’s actions 10 years ago now endangers patients’ lives, including children, and European manufacturing sites. Is that what the EU wants…
