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),…
As at the end of March 2023, there have been some further additions to the lists of Notified Bodies now designated under the MDR and IVDR. The latest additions are: MDR: 29 November 2022, Institute for Testing and Certification, Czech Republic 8 December 2022, ICIM, Italy 20 January 2023, SLG Pruf und Zertifizierungs, Germany 20…
A new Commission Implementing Regulation will soon be published to align the implementation timescale for the Common Specification (CS) on MDR Annex XVI products with the revised transition timescales for legacy devices covered in Regulation (EU) 2023/706. The full title of the new regulation as currently drafted is: “Regulation amending Commission Implementing Regulation (EU) 2022/2346…
The US Food and Drug Administration has published a final guidance document titled: ‘General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff’, available from here. The introduction to the guidance states: “This guidance document provides the FDA’s recommendations on animal studies intended to evaluate medical…
