The European Medical Devices Coordination Group (MDCG) has just published a new guidance document titled ‘Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal…
The NANDO website for the In Vitro Diagnostics Regulation (IVDR, 2017/746) has at long last reported an increase in the number of notified bodies designated to act under this regulation, from three to four. The latest addition is TÜV SÜD Product Service GmbH Zertifizierstellen, Germany, notified body reference number 0123. Although the date of application…
The European Commission website page devoted to EUDAMED has now been updated to provide information on when the first modules of the system needed to support the new device regulations will be available for the various actors to use on a voluntary basis. The webpage explains that: The development and implementation of EUDAMED is a…
The pan-European industry association MedTech Europe has published four documents in recent days to assist device manufacturers navigate the coronavirus pandemic and the transition to compliance with the new regulations (MDR, 2017/745 and IVDR, 2017/746). The statement relates to the potential for clinical investigations, including post-market clinical follow-up (PMCF) studies needed for recertification purposes, to…
On 18 May 2020, the European Commission published in the Official Journal of the European Communities ‘Implementing Regulation (EU) 2020/666 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies’. The 920/2013 regulation detailed “a common interpretation of the main elements of the criteria for…
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…
