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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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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 The 61-page guidance revises a draft guidance issued in July 2014 and supersedes a guidance issued in September 1998.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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MedTech Europe makes transition extension manufacturer’s declaration template available

MedTech Europe has made a template Manufacturer’s Declaration available to facilitate the declaration of manufacturers with respect to compliance with Regulation (EU) 2023/607, allowingmanufacturers to take advantage of the recently announced transition extension timescale for legacy devices. Any manufacturer may freely use the template to make their own declaration, or it may also be completed…

July 4, 2023
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MDR/IVDR Notified Body updates

As at the end of March 2023, there have been some further additions to the lists of Notified Bodies now designated under the MDR and IVDR. The latest additions are: MDR: 29 November 2022, Institute for Testing and Certification, Czech Republic 8 December 2022, ICIM, Italy 20 January 2023, SLG Pruf und Zertifizierungs, Germany 20…

March 29, 2023
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