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COMPANY NEWS

Donawa Lifescience Consulting announces opening of CRO office in United States

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…

Avoiding delays when conducting medical device clinical or IVD performance evaluation studies in Germany

Germany is a sought-after location for conducting medical device clinical studies and in vitro diagnostic (IVD) performance evaluation studies. This article discusses certain aspects of conducting such studies in Germany, which if not clearly understood, can lead to unnecessary and costly delays.

Updated regulations on FDA acceptance of medical device clinical data in effect soon

On February 2018, FDA published a final rule updating its regulations on the acceptance of clinical data generated outside or inside the US, which are intended to support any type of medical device FDA application or submission. A previous article discussed the proposed rule. This article will provide an overview of the updated regulations…

Global News

MedTech Europe updates MDR symbols guidance

The pan-European industry association MedTech Europe has updated guidance first published in May 2019 relating to the requirements in the Medical Devices Regulation (MDR, 2017/745) for new symbols to indicate specific characteristics of the devices concerned. The guidance was initially issued to provide advice while the applicable international standard, ISO 15223-1, went through the revision…

MDCG adopts IMDRF guidance on device cybersecurity

The EU Medical Device Coordination Group (MDCG) has issued new guidance to help manufacturers fulfill the cybersecurity requirements in Annex I of the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746). The 47-page guidance, which aligns with the cybersecurity guidance published by the International Medical Device Regulators Forum (IMDRF), explains both…

Brexit: progress being made

Following the General Election the UK Government is moving forward to implement the Withdrawal Agreement and the Northern Ireland Protocol, and negotiate on the future partnership with the EU. In light of the successful vote at Second Reading of the Withdrawal Agreement Bill (WAB), the Prime Minister has now confirmed the Government’s intention to stand…

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