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NEWSLETTER
Your Monthly Regulatory Newsletter
Welcome to the third edition of the regulatory newsletter, your trusted source for the latest developments, trends, and analysis in the ever-evolving regulatory landscape.
Our team of seasoned regulatory professionals and industry experts meticulously curate content to address the most pressing issues faced by professionals. We delve into topics such as regulatory compliance, quality assurance, clinical trials, post-market surveillance, labeling requirements, regulatory submissions, and many others.
Industry Updates
Sale of BD surgical instrumentation platform to STERIS
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BD have announced the $540 million sale of their surgical instrumentation platform to STERIS, as part of plans to simplify their portfolio. The sale will include the transfer of three sites and 360 employees to STERIS, and is expected to be completed by September 30th.
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Europe Updates
Regulation published regarding transitional provisions for devices without a medical purpose; Release of addendum to MDCG 2022-18.
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The European Commission has published Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council. This brief publication amends the timelines for these devices, according to the revised transitional provisions.
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An addendum has been published to accompany MDCG 2022-18, Position Paper on the application of Article 97 MDR to legacy devices which the MDD or AIMDD certificate expires before the issuance of a MDR certificate. The goal of the original position paper was to avoid a shortage in device supply in the EU. However, since the publication of Regulation (EU) 2023/607 and the extension of the MDR transition period, MDCG now consider that MDCG 2022-18 is no longer required, and that Article 97 of MDR should only be applied in very exceptional circumstances.
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FDA Updates
FDA releases an update to their Q-submission guidance, the final guidance on software submissions, and the 2023 Investigations Operations Manual; Publication of FDA DCT webinar slides.
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FDA have released an update to their 2019 guidance on the medical device Q-submission program. Comments are still being accepted on this guidance.
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The final guidance on "Content of Premarket Submissions for Device Software Functions" has been released, superseding the 2021 draft version. This document outlines the FDA's recommendations on the documentation that should be generated during software development, verification and validation to support a successful premarket submission.
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A 2023 version of the FDA Investigations Operations Manual (IOM) has been released. This comprehensive tool is primarily directed towards FDA employees performing investigational activities but its external publication allows for industry professionals to better understand FDA operations, and comply with the associated requirements.
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Following publication of draft guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices, FDA held a webinar on 20th June to support this guidance. The slides from this webinar provide a concise summary and have been made available here.
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Australia Updates
TGA releases new guidance for the transition to new manufacturer evidence for IVDs, and updated guidance on notification process for lapses in device certification.
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As of 26 May 2023, TGA is no longer accepting ISO 13485 certificates as evidence for IVD devices. Existing registrations which utilised ISO 13485 certificates will remain valid until their expiration. New guidance for manufacturers and sponsors of IVDs has been released by TGA to help with the transition to the new manufacturer evidence that is required as a result of both the introduction of IVDR, and the end of the transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence.
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TGA has released an update to their guidance on completing a notification form for lapses in medical device conformity assessment certification. Notification to the TGA of any lapses in certification is a legal requirement for medical device sponsors. The COVID-19 pandemic andthe introduction of the new EU regulations are quoted as potential sources of difficulty for the maintenance of certification. This guidance provides an overview of each section of the form with instructions for successful completion.
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AI & Cybersecurity News
Release of cybersecurity position paper by MedTech Europe; AI Cybersecurity research report released by ENISA; Amendments to the AI Act; How do the think tanks feel about AI?
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MedTech Europe has published a position paper on their vision for cybersecurity in medical technology. The paper examines three key areas - firstly that cybersecurity should continue to be regulated in the EU under MDR and IVDR, secondly MedTech Europe's commitment against ransomware, and finally their support for measures aimed at improving digital literacy and cybersecurity skills in particular.
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ENISA (The European Union Agency for Cybersecurity) has released a report on artificial intelligence and cybersecurity research. The report is an output of ENISA's work in fulfilling its mandate under Article 11 of the Cybersecurity Act.
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Detail on the amendments to the AI Act that have been adopted by the European Parliament have been released. This is a comprehensive document which contains detail on 771 amendments to the text proposed by the Commission. Details of the amendments can be found here.
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The European Parliament has released a briefing on "What the Think Tanks are Thinking". This document contains links to a variety publications on the topic of AI, from March - June of this year.
MHRA Updates
Information released on the future of medical device registration in the UK.
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Statutory Instrument 2023 No. 627 has been approved and released by the UK government to officially amend the Medical Devices Regulation (2002). This comes into force on 30th June 2023 for Regulations 1 to 4, and 1st July 2023 for Regulations 5 - 10. The accompanying explanatory note states that the purpose of the regulations is to extend the periods for which EU compliant devices may be placed on the Great Britain market.
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MHRA has updated their guidance on the "Implementation of medical devices future regime" to include a useful infographic on the timelines for placing both IVDs and medical devices on the Great Britain market, according to device classifications. The guidance also indicates that it is intended for core aspects of the future regime to apply from 1st July 2025.
Standards Updates
Publication of 2023 revision of ISO 10993-17 expected soon; New sterilization standard ISO 11737-3:2023 published related BET methods.
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A 2023 revision of ISO 10993-17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents is currently under publication. Proof of the updated standard was returned by the secretariat at the start of June, and the updated standard is expected to be published soon.
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A new sterilisation standard, ISO 117373-3, entitled Sterilisation of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing has been published, and is related to bacterial endotoxin test (BET) methods for healthcare products, using amebocyte lysate reagents.
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