Donawa Lifescience President, Maria E. Donawa M.D., is scheduled to speak at the 2nd Conference on Clinical Studies with Medical Devices and IVDs, taking place in Vienna, Austria, on 30-31 March 2023. This year’s conference is designed to provide a wealth of information for both medical device and in vitro diagnostic clinical investigations, with a…
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),…
Following last week’s formal approval of the European Commission’s proposal to extend the transition timelines for certain ‘legacy devices’ and eliminate the ‘sell-off period’ from the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostics Regulation (IVDR, 2017/746), Amending Regulation (EU) 2023/607 has now been published. The Preamble to the Regulation states, as industry…
In the UK Chancellor of the Exchequer’s budget statement on Wednesday 15 Marcy 2023, the potential future of medical device regulation was included. Based on an interim report from Sir Patrick Vallance, UK Government Chief Scientific Adviser, dated 8 March 2023, the Chancellor announced a commitment to some of the early outcomes of the ‘Regulatory…
Commission Delegated Regulation (EU) 2023/502 of 1 December 2022, which took on 11 March 2023, reduces the frequency of complete re-assessments of notified bodies from three years (1st complete re-assessment) and four years (following the 1st) to every 5 years in both cases; however, the competent authorities have the liberty to decide if complete re-assessment…
