Closing out 2024, we bring you substantial medical device updates from Europe, Brazil, and beyond, including the launch of public consultation on EU device regulations, an updated roadmap for regulatory implementations in the UK, and several new and updated resolutions in Brazil.
EU Member States have endorsed the new COMBINE programme, a cross-sector initiative designed to streamline combined studies of medicines, medical devices, and diagnostics. The programme will unfold over several years through seven key projects aimed at enhancing collaboration between national authorities, the European Medicines Agency, ethics committees, and stakeholders. Key goals include piloting a unified assessment process for multi-country studies, harmonizing serious adverse event reporting, and clarifying the intersection of clinical trial and medical device regulations. This strategy is part of the EU’s broader efforts to bolster competitiveness in clinical research.
The European Commission has launched a public consultation and call for evidence as part of the targeted evaluation of EU legislation on medical devices and in vitro diagnostic devices. This consultation invites stakeholders to share their views on the effectiveness of current regulations, highlight potential shortcomings, and evaluate the impact on costs, administrative burdens (especially for SMEs), and innovation in the industry. The evaluation will also examine how the rules affect device availability, including orphan devices, and benefits for patients. The consultation is open until March 21, 2025.
The European Commission has released an updated Q&A on manufacturers' obligations under Regulation (EU) 2024/1860, aimed at managing risks from supply interruptions or discontinuations of medical devices and in vitro diagnostic medical devices (IVDs). Key highlights include:
This amendment aims to enhance transparency and patient safety. Read the full Q&A for details on compliance and timelines.
Learn more about EU Medical Device Registration.
The MHRA has issued updated guidance (16 December 2024) for healthcare institutions in England, Wales, and Scotland on the in-house manufacture of medical devices. Key points include:
This guidance does not apply to independent dental practices or in vitro diagnostic devices (IVDs), which have separate regulations. The guidance remains under review, with further updates expected.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released an updated roadmap detailing its timeline for implementing new medical device regulations. This December 2024 revision outlines progress in post-market surveillance legislation, ongoing consultations on pre-market requirements, and the development of four key policy areas, including Exceptional Use Authorization and health institution exemptions. Additionally, four new software guidance documents focusing on AI, cybersecurity, and digital mental health are expected in 2025. The revised roadmap reflects the UK's commitment to refining its regulatory framework to ensure innovation and safety in the medical device sector.
Learn more about MHRA UK Medical Device Registration & Approval.
ANVISA has clarified import procedures for medical device components, following RDCs 860/2024 and 939/2024. Key updates include exemptions from Operating Authorization for importers of parts and accessories linked to regulated equipment, and new terms for imports aimed at manufacturing, repairs, or replacements. Bonded warehouses under special customs regimes are also exempt from authorization for component storage. Importers with rejected processes before December 4, 2024, must reapply for updated evaluation. These changes aim to streamline compliance and improve regulatory clarity.
ANVISA has revised its procedures for filing classification requests for borderline health products. The updates outline the minimum required information for the Product Classification Form and encourage prior consultation through ANVISA’s online service channels.
Included in the 2024-2025 Regulatory Agenda, this initiative (Theme 1.25) aims to streamline classification processes, enhance efficiency, and foster access to innovative health technologies. Borderline products, which may span categories like medical devices, medicines, or cosmetics, often require tailored regulatory paths due to unique characteristics.
ANVISA (National Health Surveillance Agency) has issued RDC Resolution No. 947/2024, establishing new procedures for document submission within its scope. Key updates include mandatory electronic filing for all documents, with paper submissions accepted only in specific cases as outlined by law. Email submissions are prohibited unless explicitly authorized. The resolution also introduces a 24/7 accessible electronic petitioning system, electronic signature requirements (ICP-Brasil or Gov.Br), and automatic protocol receipts for tracking. The new guidelines come into effect in 90 days, replacing previous resolutions, and provide clarity on document formats and user registration for external parties. Full details can be accessed here.
ANVISA has published RDC No. 949/2024, amending RDC No. 907/2024 and internalizing MERCOSUR Resolution No. 18/2023, bringing Brazilian regulations for personal hygiene products, cosmetics, and perfumes in line with MERCOSUR technical standards. Key updates include the introduction of two product categories (Grade 1 and Grade 2) with varying health surveillance requirements, new product definitions (e.g., dermal patches, self-tanning products, hair dyes), and alignment of labeling, technical, and microbiological requirements. Companies with registered products must comply with the new rules by January 2, 2030. The resolution will come into effect on March 3, 2025. For more information, access the publication here.
Learn more about ANVISA Brazil Medical Device Registration.
Good Manufacturing Practice (GMP) clearances issued via the Mutual Recognition Agreement (MRA) pathway, set to expire on 31 December 2024, will be automatically extended until 31 December 2025. This measure addresses ongoing delays in inspection frequencies with MRA partners. Sponsors do not need to apply for these extensions, and any submitted applications will be removed from the system.
Sponsors should continue monitoring inspections for overseas facilities and submit renewal applications if recent inspection evidence is available. For questions or specific situations, contact GMPclearance@health.gov.au.
Learn more about TGA Australia Medical Device Registration.
The Health Sciences Authority (HSA) has introduced a pilot Change Management Program (CMP) for Software as a Medical Device (SaMD), machine learning-enabled SaMD, to streamline regulatory processes. This optional pathway integrates with HSA's Premarket Product Registration and Change Notification (CN) processes and introduces "Pre-specified Changes."
Effective 4 December 2024, stakeholders can enroll in CMP by submitting required documents via MEDICS and notifying HSA by email. Updated guidance based on stakeholder feedback is now available. Access the final document, GN-37-R1 Guidance on CMP for SaMD.
For details, email HSA_MD_Info@hsa.gov.sg with the subject "CMP enrollment."
Learn more about HSA Singapore Medical Device Registration.
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