The Regulatory Newsletter: Edition 4

?? Happy Friday and welcome to the fourth edition of the regulatory newsletter, your trusted source for the latest developments, trends, and analysis in the ever-evolving regulatory landscape!

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Industry Updates

Job cuts at BD

• Following a wave of job cuts in the medtech industry, BD have announced the elimination of 60 jobs at its Drogheda facility, partially as a result of the COVID-19 pandemic and the resulting decrease in demand for devices used in non-critical procedures. The jobs will be cut over the next 15 months.

AI and Cybersecurity News

European parliament release a briefing on the progress of AI legislation, and a report on the use of AI in healthcare; Article published on upcoming British standard on AI.

• The European Parliament has published a briefing on the progress of the new EU legislation on AI. Lawmakers are working to finalise the legislation? which parliament voted on in June 2023. The AI Act, when published, will introduce a risk-based classification approach to AI systems, with varying requirements to be introduced, depending on the level of risk posed by the systems.
• A report has been released by the European Parliament on AI in healthcare. The report examines the areas to which AI can contribute, identifies risks associated with its use, and proposes policy options that would aid in counteracting these risks. There are seven main risks identified in the report:- Patient harm due to AI errors- Misuse of biomedical AI tools

- Risk of bias in medial AI and perpetuation of inequities

- Lack of transparency

- Privacy and security

- Gaps in accountability

- Obstacles to implementation in real-world healthcare

• A communication was published by BMJ on the upcoming British standard on the validation framework for the use of AI within healthcare. This article gives an overview of the standard and the benefits that it will bring to the healthcare industry. The standard is currently at the approval stage, which is the last stage before publication.

Europe Updates

New MDR notified body; Update to the OJEU for MDR and IVDR; BSI publish best practice IVDR submission guidelines; European Commission publish MDR and IVDR factsheet, a Q&A on MDR transition period, and the results of a notified body survey.

• A new notified body has been designated under MDR - Health Technology Certification, Cyprus (#2803)
• An amendment has been published for the standards published in the OJEU in support of MDR and IVDR. EN ISO 25424:2019 (Sterilization of health care products - low temperature steam and formaldehyde - requirements for development, validation and routine control of a sterilization process for medical devices) has been replaced by EN ISO 245:20198/A1:2022.Additionally, a new addition has been made to the MDR list with EN ISO 10993-10:2023 (Biological evaluation of medical devices - Part 10: Tests for skin sensitisation). This brings the current total of harmonised standards to 17 for MDR, and 10 for IVDR.
• BSI have released best practice guidelines on the submission of IVDR documentation. This guidance is intended to speed up the certification process by reducing submission issues and improving review timelines. While these guidelines specifically outline BSI expectations, they will also be helpful for manufacturers with other IVDR designated notified bodies.
• The European Commission has published a factsheet on medical devices and IVD medical devices, for regulatory authorities in non-EU countries. The factsheet gives a high level overview of the timelines and purposes of the new regulations.
• A Q&A document has been released by the European Commission on the extension of the MDR transition period and the removal of the sell off periods for both MDR and IVDR. The document is broken down into 5 parts, covering:- The scope of the transition period and the devices which can benefit;- The evidence required to demonstrate that a legacy device can benefit from the extension;- The conditions that must be fulfilled;- Surveillance to be performed by notified bodies;- The devices that will benefit from the removal of the sell off date

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• The European Commission has released the results of a notified body survey on MDR and IVDR certifications and applications. The survey was carried out in April and included input from 39 notified bodies (38 designated under MDR, and 10 designated under IVDR). Among other topics, the survey provides information on completeness of submissions, time to reach certification, the number of certificates issued, and reasons for refusal.

MHRA Updates?

Indefinite extension of CE mark recognition in the UK; Publication of draft SI on PMS; MHRA release guidance on registration of class I devices, and update guidance documents on software and AI, device registration, borderline products, and IVD regulation.

• The MHRA's draft Statutory Instrument on The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 has been published on the WTO website. Comments are accepted for 60 days from notification. It is proposed that the Statutory Instrument will be adopted in December 2023, before coming into force in June 2024.

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• MHRA has released guidance specific to the registration of reusable class I devices, up-classified class I devices and/or reliant on expired or expiring CE certificates. The guidance presents 6 scenarios, providing step-by-step guides on how to register or declare a device that falls into these categories.

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• An update has been released to the MHRA guidance on software and AI as a medical device. This update includes a reference in the AI section to an MHRA project that ran from October 2021 to March 2022, which focused on significant change in adaptive AI algorithms and in what way such changes should be regulated.

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• MHRA has released updates to their guidance on registering medical devices to place on the UK markets. These updates include reference to an increase in registration fees to ￡240 per application, and a letter template for the MDR Article 120 extension confirmation. The template is in the form of a declaration of compliance to the Article 120 requirements.

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• MHRA guidance on "Borderline products: how to tell if your product is a medical device and which risk class applies" has been updated to include an annex, "MHRA borderline determinations". This addition is intended to assist manufacturers in assigning the correct classification to their device.

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• MHRA guidance on the regulation of IVDs in Great Britain has been updated. This is the first update since December 2020 and includes information on the more recently updated timelines for the application of the UKCA mark.

FDA Updates?

FDA releases draft guidance on orthopedic patient-matched guides, and updated guidance on MDDT qualification; new sterilization standard recognized by CDRH.

• FDA has released a draft guidance document on patient-matched guides to orthopedic implants. The guidance is intended to provide clarity on the expectations for submissions for orthopedic patient-matched guides, as well as the recommended best practices for certain elements of the design process for such devices. Comments are being accepted until late August.
• ?The FDA issued guidance document for the qualification of medical device development tools has been updated. This document, released on 17th July, supersedes the original 2017 version. The purpose of the guidance is to describe the framework for the qualification of an MDDT and is intended to ultimately facilitate more efficient regulatory submissions.

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• The CDRH will now recognise ISO 22441:2022 Sterilisation of healthcare products - low temperature vaporised hydrogen peroxide - requirements for the development, validation and routine control of a sterilisation process for medical devices as a consensus standard. This development by the FDA is in response to the EPA's move to limit the use of ethylene oxide.

Australia Updates

TGA releases update to guidance on CA recertification delays, new guidance on varying ARTG entries, and seeks public feedback on proposed application audit framework.

• TGA has released an update to the guidance on their approach to delays in medical device conformity assessment recertification, due to COVID-19 and the implementation of MDR and IVDR. This guidance applies to Australian and overseas conformity assessment documents, and is intended to inform sponsors and manufacturers about how TGA handle lapsed certification, depending on the specifics of the individual cases.

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• A guidance document has been published by TGA on varying entries in the ARTG for medical devices and IVDs. This guidance is intended for sponsors applying to TGA to change information recorded in the ARTG. The document provides information on scenarios requiring an ARTG entry change along with guidance on how to make these changes.

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• Public feedback is being sought by TGA on their recently released consultation paper on the proposed application audit framework for medical devices in Australia. The paper outlines the current application audit process, and introduces the new application audit framework. Feedback is specifically requested on:- risk factors informing non-mandatory audit selection- criteria for mandatory audits- the evidence to be provided with applications to inform audit selection- limiting the number of substantial assessment rounds- mechanisms to improve visibility of application audit timeframes- cost recovery measures for non-mandatory audits- pathways for Class III 510(k) approved devicesThe consultation window opened on 24th July and will close on 4th September 2023.

Other Updates

WHO has released a draft guidance document on best practices for clinical trials. This guidance has been launched following the adoption of a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination in May 2022. Comments on the content of the guidance are welcomed by WHO until 15th September.

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