Our MedTech news for November 2024 covers MedTech Europe’s recommendations for EU Green Deal implementation, MDCG guidance on the regulatory status of EtO, Q&As on gradual EUDAMED roll-out and medical device supply interruption & discontinuation, and a questionnaire from Team NB on AI in medical devices.
Guidance from Swissmedic on clinical investigations, performance studies, and combined studies also features, as well as MedTech updates from the US spanning EtO sterilization facility changes for Class III devices, final guidance for orthopaedic non-spinal bone plates, screws, and washers, and a whitepaper on SBOM from MITRE.
For all this and more, read on.
MedTech news from the EU
MedTech Europe issues recommendations for patient-centric EU Green Deal implementation
On 11 November, following the EU Commission’s announced Sustainable Prosperity and Competitiveness Plan, MedTech Europe issued 10 recommendations for a patient-centric Green Deal implementation, and the building of more sustainable, equitable, and climate-resilient healthcare systems in Europe. You can read the recommendations here.
Guidance shared on regulatory status of Ethylene Oxide (EtO) intended for medical device sterilization
Ethylene Oxide (EtO) is used to sterilise a wide range of medical devices and in vitro diagnostic medical devices (IVDs), as well as combined products. The MDCG has shared guidance that aims to ensure that the use of EtO in sterilization processes aligns with the appropriate regulatory frameworks, to maintain the safety and efficacy of medical devices and IVDs on the EU market.
You can read MDCG 2024-13 here.
COCIR & MedTech Europe share vision for strengthening healthcare cybersecurity
Earlier this month, the COCIR (the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries) and MedTech Europe released a joint paper communicating their shared vision for enhancing the resilience of healthcare infrastructures through comprehensive cybersecurity measures.
The joint paper includes recommendations regarding increasing capacity and expertise in healthcare, raising awareness amongst stakeholders, developing guidelines for the use of the NIS-2 Directive in healthcare, focusing on a supportive cloud ecosystem, and embedding cybersecurity in healthcare procurement. Find out more here.
MDCG shares updated Q&A on vigilance terms outlined in MDR & IVDR
This month the MDCG published an updated Q&A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Read MDCG 2023-3 rev.1 here.
EU Commission publishes Q&As on gradual EUDAMED roll-out and medical device supply interruption & discontinuation
This month the EU Commission published Q&As on practical aspects related to the implementation of the gradual roll-out of EUDAMED, and the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices, in line with MDR and IVDR as amended by Regulation (EU) 2024/1860.
Team NB issues questionnaire on AI in medical devices
Prepared in accordance with a request made in MDCG 2022-14, Team NB has issued a questionnaire to help with the development of common guidance for manufacturers to assist during the application phase.
The questionnaire is to be understood in the context of MDR and IVDR, as well as MDCG guidance (MDSW). Whilst specific requirements of the AI Regulation 2024/1689 have not been considered, they will be part of a comprehensive revision which will follow. There is however, a considerable overlap of requirements stated in the AI Regulation and the existing regulatory and standards framework for software and AI. You can read the questionnaire here.
MedTech guidance from Switzerland
Swissmedic advises on clinical investigations & performance studies
Swissmedic has released two information sheets regarding clinical investigations and performance studies that provide guidance on the approval process, reporting requirements of sponsors, and the surveillance by Swissmedic.
BW600_00_015e_MB Clinical investigations with medical devices is intended for sponsors of clinical investigations of medical devices, contract research organisations (CROs), and investigators, and BW600_00_016e_MB Performance studies with IVD is intended for sponsors of performance studies of IVDs, CROs, and investigators.
Swissmedic shares information on combined studies
Swissmedic has issued an information sheet that covers topics unique to combined studies in terms of their submission for approval to Swissmedic, and study conduct. Intended for sponsors of combined studies, CROs, and investigators, BW600_00_017e_MB Combined studies is now available to read.
MedTech updates from the US
FDA issues Transitional Enforcement Policy for EtO sterilization facility changes for Class III devices
This week the FDA issued guidance to communicate its policy regarding sterilization site changes for Ethylene Oxide (EtO) sterilized PMA and HDE devices in situations where those devices are affected by the potential, actual, or temporary operation reductions at sterilization facilities that may affect the availability of those sterile medical devices.
The guidance describes information that medical device manufacturers may provide when notifying the FDA of a sterilization facility site change that will be conducted according to the policy in the guidance.
You can read the final guidance here.
FDA publishes final guidance for orthopaedic non-spinal bone plates, screws, and washers
This month the FDA has published final guidance documents relating to orthopaedic non-spinal bone plates, screws, and washers.
This guidance document provides the FDA’s recommendations on information to support premarket 510(k) submissions for the medical products, and this guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of the Safety and Performance Based Pathway. Under the latter framework, those planning to submit a 510(k) using the Safety and Performance Based Pathway for non-spinal metallic bone screws and washers will have the option to use the performance criteria proposed in the guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
MITRE publishes Data Normalization Challenges & Mitigations in SBOM whitepaper
Published by MITRE this month, the whitepaper is intended for medical device sector stakeholders and discusses data normalization challenges and recommended mitigations for producing software bills of materials (SBOMs), ingesting SBOMs at scale, and related issues. Access the resource here.
MedTech news from China
China’s NMPA proposes clinical trial exemption for 387 IVD reagents
On 5 November, the NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents (Draft)” which newly includes 387 IVDs. Implementing risk-based clinical evaluation, the catalogue is intended to improve consistency between clinical exemptions and internationally accepted standards. Find out more on this here.
NMPA releases “Made in China” guideline
On 4 November, the NMPA released its “Announcement on Further Clarifying Matters Related to the Domestic Production of Imported Medical Devices in China (Draft)” to boost domestic production of imported medical devices.
The draft guideline updates the initial regulation released in 2020 (Decree 104) and introduces changes to the rules governing foreign-invested enterprises (FIEs) involved in producing imported medical devices domestically in China. The updates span an expanded scope of application, enhanced requirements for registration, registration system verification requirements, and special considerations for innovative devices.
Read more on the guideline here.
That concludes our November 2024 MedTech news roundup, the last roundup for this year! We’ll be back at the end of January with more medical device news and updates.
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