This week in global medical device news: Brazil's ANVISA goes 100% digital, more Approved Bodies in the UK, revised guidance on HIV self-test kits in Malaysia, and more.
On 7 February 2025, the MDCG 2019-6 Rev. 5 update introduced a new Question IV.13, addressing the concept of "leveraging evidence." This addition clarifies how notified bodies can avoid unnecessary duplication in conformity assessments and outlines the necessary documentation manufacturers must maintain to ensure traceability and compliance. Understanding these updates is crucial for streamlining regulatory processes and demonstrating prior assessment evidence effectively.
On 6 February 2025, the EU launched a pilot coordinated assessment for clinical investigations and performance studies under MDR Article 78 and IVDR Article 74. This initiative aims to streamline submissions, allowing sponsors to apply through a single process across multiple Member States, enhancing harmonization in regulatory approvals. Currently, separate applications are required for each Member State, involving both Ethics Committees and competent authorities. Manufacturers and sponsors planning multinational studies in at least two participating countries are invited to apply for this pilot program.
Learn more about EU Medical Device Registration.
The UK government has updated its list of approved bodies for medical device certification as of 19 February 2025. This guidance provides details on organizations authorized to issue UKCA certifications under the UK MDR 2002 for medical devices, in-vitro diagnostic devices, and active implantable medical devices. Manufacturers can find key contacts, designated scopes, and certification expiry dates for each approved body. Stay informed to ensure compliance with UK regulatory requirements.
Learn more about MHRA UK Medical Device Registration & Approval.
On 17 February 2025, Swissmedic evaluated post-market surveillance compliance for 30 legacy medical devices in risk classes IIa and higher. The assessment revealed non-conformities in 20 out of 30 cases, with a total of 85 issues identified under MedDO Articles 56, 58, 60, and 61. Given that these requirements have been in force since 26 May 2021, Swissmedic is expected to follow up on corrective actions and enforce additional measures to ensure regulatory compliance for devices on the Swiss market. Manufacturers must remain vigilant in meeting post-market surveillance obligations.
Learn more about Switzerland Medical Device Registration.
The Medical Device Authority (MDA) has released the second edition of Guidance Document MDA/GD/0065 to assist industry stakeholders and healthcare professionals in complying with Malaysia’s Medical Device Act (Act 737). This document outlines requirements for the registration, licensing, labeling, sales, distribution, and post-market surveillance of HIV self-test kits (HIVST). It must be read alongside relevant Malaysian medical device laws and regulations, including Act 737 and Circular Letter No. 2/2023. Access the full guidance document for detailed compliance requirements.
Learn more about MDA Malaysia Medical Device Registration.
Starting March 13, 2025, ANVISA will fully transition to a digital document protocol under RDC 947/2024. Paper documents will no longer be accepted, submissions must be made electronically through systems like Solicita and SEI. This change aims to streamline processes, reduce costs, and enhance document security through electronic signatures, in compliance with Law 14,063/2020. Accepted signatures include qualified digital certificates (ICP-Brazil) and advanced digital signatures via Gov.Br. Stay prepared for the transition by reviewing the full resolution.
Learn more about ANVISA Brazil Medical Device Labeling Requirements.
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Your IVD's intended purpose determines its classification, clinical evidence requirements, and clinical applications under the IVDR. Device companies will need a more robust intended purpose to fulfill IVDR criteria. In this article, Dr. Oliver Eikenberg explains the role of the intended purpose in IVDR compliance.
Pure Global participated in IMDEC 2024 in Kuala Lumpur to discuss the latest advancements in medical technology, regulatory efficiency, and the role of AI in transforming the industry. Highlights included updates from the Malaysian Medical Device Authority (MDA) that showcased their commitment to driving regional leadership in medical device regulation and innovation.
