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get_the_date('F j, Y') Notified Body Update

TuV SUD Denmark becomes the 45th Notified Body to be designated under the MDR, and is the first from Denmark. This compares with there now being 12 Notified Bodies designated under the IVDR. The full list of designations under the MDR can be found here, and the IVDR list can be accessed here.

13 April 2024
get_the_date('F j, Y') Phthalates SCHEER guidelines update proposal published

The European Commission has launched a public consultation on an update to its guidelines on benefit-risk assessments for medical devices containing phthalates. This is the first time the Commission has proposed updating the guidelines since they were released in 2019. The proposed update was published on 21 March 2024 by the Commission and its Scientific…

13 April 2024
get_the_date('F j, Y') Maria Donawa interviewed by MEDTECH INSIGHT

Donawa Lifescience President, Maria E. Donawa, M.D., has been interviewed by Amanda Maxwell of MEDTECH INSIGHT on the subject of European medical device guidance document MDCG 2024-3 concerning clinical investigation plans in the journal dated 8 April 2024. The guidance, full title ‘Guidance on the content of the clinical investigation plan for clinical investigations of…

12 April 2024
get_the_date('F j, Y') Maria Donawa posts article on device clinical evaluation plans on LinkedIn

Donawa Lifescience President, Maria E. Donawa, M.D., has authored a ‘Regulatory Recap’ article on LinkedIn titled ‘CEPs: Parameters vs outcome parameters, what’s the difference?’ The topic arises because of confusion among manufacturers, notified bodies, and competent authorities regarding the interpretation of certain requirements of the EU Medical Device Regulation (MDR, 2017/745) for clinical evaluation plans…

3 April 2024
get_the_date('F j, Y') Four opinions issued by expert panels July22-June23

The European Commission has recently published its annual report on devices subject to the clinical evaluation consultation procedure (CECP), available from here. Titled ‘Commission Staff Working Document: Annual overview of devices subject to the clinical evaluation consultation procedure pursuant to Article 54(4) of Regulation (EU) 2017/745 on medical devices (July 2022-June 2023)’, the report identifies…

3 April 2024
get_the_date('F j, Y') Many more MDR/IVDR guidance documents on their way in 2024

MDCG has published its updated schedule for MDR/IVDR guidance documents, revealing that more than 50 are scheduled to be released before the end of 2024. Copies are available from this web address.

28 March 2024