Regulatory Newsletter (Edition 14)
We're back with the latest issue of Trinzo’s regulatory newsletter – your one-stop shop for the latest developments in the regulatory world! Our team of industry insiders have been busy combing through content around the globe, from emerging trends to in-depth analysis.
So grab a coffee, sit back and read the latest updates in the regulatory landscape. ?? Don't forget to hit the subscribe button to make sure you never miss an edition, and share with a friend who might find it helpful!
FDA
FDA has issued final guidance on Remanufacturing of Medical Devices. This guidance is intended to provide clarity on whether the activities performed on devices should be considered "servicing" or "remanufacturing". The content of the guidance is largely focused on activities that the FDA consider to be "remanufacturing" and aims to promote better understanding of the associated statutory and regulatory requirements of these activities.
There has been an update to the FDA's list of US marketed AI/Machine-Learning enabled medical devices. As of the May 13th update, there are 882 devices on this list.
MDR & IVDR
Four new MDCG documents related to preliminary assessments and re-assessments have been released:
These forms are intended for use by designating authorities assessing and re-assessing notified bodies for designation under MDR and IVDR.
MDCG 2024-1-5 (DSVG 05) has been released providing device specific vigilance guidance on urogynaecological surgical mesh implants used for pelvic organ prolapse repair and stress urinary incontinence. This document outlines the way in which incidents with these devices should be reported to competent authorities.
MDCG 2022-4 on guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD, has been updated to Revision 2. This new revision contains updates throughout the guidance to achieve alignment to Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
Team NB has released a press release outlining the findings of its 2023 medical device survey. The results of the survey include input from 35 notified bodies and provides insight on MDR and IVDR applications and certifications in addition to transition elements related to Articles 16, 17 and 22 for AI, Annex XVI devices, and MDSAP certification.
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The EMA has published a new revision of its questions and answers guidance document for applicants, marketing authorisation holders, and notified bodies regarding the implementation of MDR and IVDR within the context of combination devices. The document specifically provides guidance in relation to:
The 47th, 48th and 49th notified bodies have been designated under MDR - MTIC InterCert S.r.l. (# 0068), Kiwa Belgelendirme Hizmetleri A.S. (# 1984), and QMD Services (# 2962) respectively.
MHRA
A statement of policy intent on the international recognition of medical devices has been released by the MHRA. This statement outlines the policy for recognition of medical device approvals from other countries in Great Britain. The comparable regulator countries (CRCs) referenced are:
There are four access routes outlined in the statement, depending on the device type and classification according the UK MDR. Specified criteria must also be met for eligibility for participation in the framework.
A public consultation has been opened by MHRA on the addition of requirements for Common Specifications for certain high risk IVDs, to allow such devices to be placed on the Great Britain market. The consultation, which is aimed at members of the public, medical device researchers, developers, manufacturers and suppliers, and healthcare professionals, remains open until 14th June 2024 and can be accessed here.
MHRA has issued guidance on software and artificial intelligence as a medical device. This guidance compiles information considered relevant and important to Software Group outputs.
MHRA has launched a new project called AI Airlock to assist with the identification of challenges related to the regulation of standalone AI medical devices. The MHRA initially support 4-6 relevant projects to test for issues that might occur when devices such as these are used for clinical purposes.
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