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Maria Donawa to speak at the 8th EAAR Annual Conference on 26-27 February 2024

The 8th EAAR Annual Conference on New Medical Device Regulations (RMD2024) will take place in Brussels, Belgium, on 26-27 February 2024, featuring speakers from across the MedTech industry, including regulators and notified bodies. Organized by the European Association of Authorised Representatives (EAAR), the conference serves as an inclusive platform for all stakeholders across the both medical…

October 20, 2023
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FDA issues guidances on use of eSTAR

The US Food and Drug Administration (FDA) has issued two guidance documents relating to the use of the eSTAR (electronic Submission Template And Resource) submission process, which became the mandatory route for 510(k) submissions on 1 October 2023. The two guidances are: Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and Food…

October 3, 2023
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Donawa Lifescience personnel to speak at CTRMD2023 Conference

Donawa Lifescience VP Operations and Clinical Affairs, Daniela Karrer, and Director, Clinical Affairs, are both scheduled to deliver papers at The American Conference on Clinical Trials and Regulation of Medical Devices, taking place in Orlando, Florida, USA, from 20 to 21 November 2023. The conference is intended to be of special interest to regulatory affairs,…

October 3, 2023
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FDA issues final guidance on obtaining informed consent

The US Food and Drug Administration (FDA) has announced the finalization of guidance to help institutional review boards (IRBs), clinical investigators, and sponsors comply with informed consent regulations for clinical investigations. The 61-page guidance revises a draft guidance issued in July 2014 and supersedes a guidance issued in September 1998. The document provides general guidance…

August 17, 2023
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TEAM-NB issues Position Paper on New MDR Transition Timelines and Notified Body Capacity

The industrry association for medical device notified bodies, TEAM-NB, explains that while extending the deadline for transition to EU Medical Device Regulation (MDR) compliance has been a positive move, there is more regulators and industry can do to ensure manufacturers can recertify their products on time to meet the new deadlines. In its recently issude…

August 16, 2023
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FDA annouces CDRH user fees for Fiscal 2024

The US Food and Drug Administration (FDA) has announced the user fees that will be payable by medical device manufacturers for interactions with the Agency’s Center for Devices and Radiological Health (CDRH) during Fiscal Year 2024, starting on 1 October 2023. The new fees, which include an increase of around 7.6% over the previous year,…

August 14, 2023
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UK announcement on UKCA delay causes confusion for MedTech

The announcement by the UK Government Department for Business and Trade (DBT) on 1 August 2023, that a broad acceptance of CE marks instead of the UKCA mark for the forseeable future, briefly caused confusion among the medical device community, considering that only weeks before had the transition deadlines for legacy medical devices been extended…

August 4, 2023
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EUDAMED update

The latest news from the European Commission is that a fully functional EUDAMED is now not likely to be available until . Originally scheduled to be completed in May 2020, the much delayed roll-out is now taking place in phases, rather than all modules at one time. While some modules are already available, European officials…

August 4, 2023
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FDA updates device consensus standards list

The US Food and Drug Administration (FDA) has updated and expanded its list of premarket medical device consensus standards that include important topics such as medical device cybersecurity, sterilizing products using radiation and using certain materials and alloys. FDA published tables on 1 August listing voluntary consensus standards that are either withdrawn, replaced, corrected or…

August 3, 2023
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Cyprus names first notified body

The 39th notified body for the medical device regulations 2017/745 and 201/746 (MDR and IVDR) has now been named, this being Health Technology Certification (HTC), located in Nicosia, Cyprus. Details of all currently available notified bodies (29 for MDR and 10 for IVDR) are available on the NANDO MDR and IVDR websites.

July 15, 2023
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