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COMPANY NEWS

Donawa Lifescience project continuity during Covid-19 Italian restrictions

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 participating in RAPS 2020 Euro Convergence Conference

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…

Maria Donawa to chair Vienna Conference on Clinical Studies with Medical Devices and IVDs

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…

Global News

Commission proposing a 12 month delay to MDR

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…

Commission publishes updated lists of harmonised standards for Directives

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…

MTE calls for Commission to delay MDR due to Covid-19

The European medical technology industry association, MedTech Europe, has issued a press release calling on the European Commission to delay the date of application of the Medical Device Regulation (MDR, 2017/745) until six months after the Covid-19 pandemic is officially over. A copy of the press release can be obtained from here.

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