The European Medical Device Coordination Group (MDCG) has now published a guidance document relating to how Notified Bodies will be allowed to continue conducting audits under the medical device directives during the coronavirus crisis, which has seen many countries restrict travel and issue ‘stay at home’ orders, although the document states that “for Regulations (EU)…
At the same time that the device industry is finalising a paper to send to the European Commission to delay the date of application of the Medical Device Regulation (MDR, 2017/745) until at least six months after the Covid-19 pandemic is over, the Commission itself announced it will be proposing a 12-month delay as a…
The Official Journal (OJ) of the European Communities of 26 March 2020 includes Council Decisions and lists of standards that have now been ratified by the European Commission as ‘harmonised standards’, conferring ‘presumptions of conformity’ with the applicable Essential Requirements of the three device directives, these being: Medical Device Directive (MDD, 93/42/EEC) Active Implantable Medical…
We would like to advise clients that the Donawa team in our Rome office is fully operational. We have implemented a fast smart-work connection that allows employees to work from home, should this be necessary, although the office will remain open as some of us live close. With regard to associates who work on projects…
Donawa Lifescience will again be participating in the 2020 RAPS Euro Convergence Conference, now being held in Brussels from 26-28 October 2020. Donawa Lifescience will be involved in two conference sessions, the first conference session specifically dedicated to In Vitro Diagnostic Devices, in which Donawa’s President, Maria E. Donawa, M.D., will chair the session, titled…
The “European Conference on Clinical Studies with Medical Devices and IVDs” (CSMD2020) will take place on 16-17 November 2020 in Vienna, Austria. The Conference is designed to address the most challenging and perplexing aspects of planning and conducting medical device and IVD clinical studies in accordance with the requirements of the European Medical Device Regulation…
Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a wholly owned company in the US State of Massachusetts, Donawa Lifescience Inc., to promote its Clinical Research Organisation activities to both its existing and potential North American clients. Donawa Lifescience Inc., together with…
