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UK government publishes further draft of the post 2020 device law

The UK government has published a further set of draft amendments to the Medical Devices Regulations 2002 (as previously amended), for which a draft amendment was published in late 2019 (the ‘Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019’), but which has now been further amended in ‘The Medical Devices (Amendment etc.)…

October 22, 2020
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Multiple guidance documents issued for Eudamed ‘Actor Registration’

The European Commission has published a number of guidance documents related to how manufacturers, authorised representatives and importers (‘economic operators’) will be able to access and register with the ‘actor registration’ module of Eudamed from 1 December 2020. A new webpage has been set up within the Eudamed website, relating only to the actor registration…

October 21, 2020
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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…

October 25, 2019
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