This week in medical device regulatory news, EU parliament moves toward a revision of the EU MDR, the UK enhances post-market surveillance requirements, US FDA prioritizes guidance revisions for 2025, and more.
The EU Commission has revised its list of harmonized standards, including new updates relevant to aseptic processing and clinical study practices. Significant updates in this revision include:
These changes were published under Commission Implementing Decision (EU) 2024/2631 on October 8, 2024, as an amendment to Implementing Decision (EU) 2021/1182. For more details, visit Commission Decision 2024/2631 and Commission Decision 2024/2625.
The European Parliament has issued a Joint Motion for a Resolution calling for an urgent revision of the Medical Devices Regulation (MDR), following a formal re-evaluation of EU regulations. This non-binding motion, supported by several parliamentary groups (EPP, S&D, ECR, Renew Europe, Verts/ALE), stems from discussions within the Medical Devices Coordination Working Group (MDCG), where the EU Commission outlined its strategy for the further evaluation of the MDR and IVDR.
The motion serves as a call to action for specific categories of medical devices and encourages the EU Commission to reconsider its priorities for regulatory improvements. However, the resolution is broad and general, without specifying concrete actions or solutions, and does not signal a major overhaul of the current framework. It is important to note that while the motion highlights areas of concern, it should not be viewed as a call for delay or as a sign of significant unresolved issues within the EU’s current regulations.
For more information on the resolution, visit European Parliament Motion and Parliament Procedure.
The updated ISO/IEC 16022:2024 and ISO/IEC 15415:2024 standards, released in 2024, focus on improving barcode identification techniques for Unique Device Identification (UDI). ISO/IEC 16022:2024 details the Data Matrix barcode symbology, while ISO/IEC 15415:2024 specifies print quality testing for 2D barcodes. Key updates include the introduction of a new print quality parameter, "print growth," and a seamless link between both standards, aligning continuous grading with all quality measurements. These revisions ensure better barcode readability and verification, crucial for UDI compliance in the medical device industry.
For more details, visit:
The EU is introducing a new initiative to streamline the Unique Device Identification (UDI) system for certain medical devices. To reduce the complexity of assigning multiple identifiers to similar products, such as spectacle frames, lenses, and ready-made reading glasses, these devices will now fall under a single identifier, the "Master UDI-DI." This approach aims to improve regulatory efficiency while maintaining the ability to trace devices when needed, enhancing safety without unnecessary duplication of identifiers.
The EU Commission has published a new Q&A document outlining the obligation for Medical Device and IVD manufacturers to inform about supply interruptions or discontinuations. This requirement, introduced by Regulation (EU) 2024/1860 under MDR/IVDR Article 10(a), mandates manufacturers to notify economic operators, competent authorities, and/or EU Authorized Representatives within specified timelines. The new obligation, effective from January 10, 2025, emphasizes the need for manufacturers to update their internal QMS processes to ensure compliance in case of supply disruptions.
Learn more about EU Medical Device Registration.
Swissmedic is reminding all economic operators registered with a CHRN to validate their migrated data on Swissdamed by 13 November 2024. Operators are encouraged to take just ten minutes to verify their company details and the data of each individual registered actor to ensure accuracy. This validation is a critical step for compliance, and all remaining operators must complete this task by the deadline.
Swissmedic's annual report, published on October 7, 2024, reveals concerning findings from inspections of 25 hospitals in 2023. The report emphasizes the need for improvements in quality management, maintenance, staff training, and infrastructure within reprocessing departments. Despite previous warnings in 2021/2022, no significant improvements were observed. Swissmedic concluded that the identified deficiencies pose risks to device safety and patient health. Moving forward, Swissmedic will intensify monitoring and collaborate with experts to develop binding guidelines for improving quality assurance in hospitals.
On October 3, 2024, Swissmedic issued a corrigendum for the "Good Practice for the Reprocessing of Medical Devices" (GPA), developed in collaboration with the Swiss Society for Sterile Materials Provision (SGSV) and the Swiss Society for Hospital Hygiene (SGSH). The updated guidelines clarify regulatory requirements for medical device manufacturers and healthcare institutions involved in reprocessing medical devices, including compliance with Article 71 of the MedDO. The corrigendum extends these requirements beyond central sterilization departments to include surgical areas, endoscopy departments, and nursing services, potentially signaling increased scrutiny for hospitals, in light of findings from Swissmedic's recent inspection report.
Learn more about Switzerland Medical Device Registration.
On October 22, 2024, the MHRA laid a Statutory Instrument (SI) in Parliament, marking the first step in Great Britain’s medical device regulatory reform. This SI focuses on strengthening post-market surveillance (PMS) requirements, enhancing patient and public safety in alignment with international standards. This update follows MHRA’s 2021 consultations on the future of UK medical device regulation. While closely aligned with EU MDR/IVDR PMS requirements, the SI will primarily impact manufacturers applying for UKCA marking directly, who must adapt their Quality Management Systems accordingly. Full legislative changes are expected to take effect in 2025.
Learn more about MHRA UK Medical Device Registration & Approval.
The FDA’s Center for Devices and Radiological Health (CDRH) has published its proposed guidance list for fiscal year 2025, outlining planned updates and inviting feedback on potential revisions. This list is organized as follows:
This list is valuable for medical device manufacturers to anticipate regulatory changes and prepare for future requirements.
On September 30, 2024, the FDA published new guidance on performance criteria for dental cements under the Safety and Performance Based Pathway. This guidance allows manufacturers to demonstrate substantial equivalence through FDA-recommended performance criteria rather than direct comparisons with predicate devices. Aimed at promoting consistency, this approach streamlines the review process for dental cements, ensuring a more efficient pathway for premarket submissions.
Learn more about FDA US Medical Device Registration.
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On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.
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