End of September 2024 brought updates from major markets: EU IVDR transition guidance for Class D IVDs, biocompatibility guidance from the US FDA, IVD family grouping regulations from Brazil, and more.
This updated document provides indications for how to apply the IVDR provisions related to expert panels and EURLs before the IVDR application date. In addition to minor revisions and updates, a new question (7) is included: “What does the date of application of the designation of EURLs (1 October 2024) mean in practical terms for EURL tasks, and in particular for sample or batch testing according to Article 100(2)(b) IVDR and performance verification according to Article 100(2)(a)?” As of 1 October 2024, notified bodies are obliged to contact an appropriate EURL and engage in the activities described in Articles 10, 11, and 13 of Commission Implementing Regulation (EU) 2022/944 for batch testing of all class D devices for which notified bodies have issued a certificate under the IVDR and that fall within a scope of a designated EURL.
Learn more about EU Medical Device Registration.
Swissmedic published on 18.09.2024 a Request to review devices that comply with the old legislation, intending to draw Swiss Authorized Representatives' and Regulatory Importers’ attention to the facts concerning the transitional provisions for legacy devices and check of products. Swissmedic also highlights the deadline approaching on September 26, 2024. Swiss Authorized Representatives and importers must verify and document the conformity of devices before they are placed on the market (e.g., through a manufacturer's self-declaration and/or the confirmation letter from the notified body).
Swissmedic published several very important information sheets. These sheets give an excellent overview of requirements and expected documents (e.g., for export Certificates and Clinical Investigations with medical devices or Performance studies with IVD and for combined studies). A specific focus is made to the submission and authorization, which later are highly relevant to acceptance by notified bodies and for CE marking.
Learn more about Switzerland Medical Device Registration.
Update on the status of the UK legislation and progress in the proposed revision of the UK MDR 2002 was given by Robert Reid, Ph.D., Deputy Director, Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA), during RAPS Conference, September 18.
The roadmap for 2024-2025, published in January by MHRA, was presented as “a refreshed roadmap” with three core statutory instruments (SI), PMS, Pre-market, and future enhancement. In summary, the PMS is expected to be more stringent and harmonize with other legislation (EU), and the essential changes to the core legislation are expected to be released in 2025 with a focus on international recognition and reliance.
In line with this presentation from RAPS, the MHRA officially provided a short status update of their MHRA activities for Med Tech regulatory change in their “MedRegs Blog.”
Learn more about MHRA UK Medical Device Registration & Approval.
UNITED STATES
With the objective to better identify design changes and their significance, as well as reduce the work associated with such changes for manufacturers, the FDA introduced this concept for “Predetermined Changes.” With this approach, manufacturers can proactively communicate their planned design changes in advance in a submission; the respective document to be delivered by the manufacturer is the Predetermined Change Control Plan (PCCP). This can be a significant effort towards a "least burdensome approach."
This draft provides the FDA’s recommendations on analytical chemistry testing to assess the biocompatibility of medical devices. It needs to be noted that chemical characterization is just one of many approaches that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. It can also support specific biocompatibility data from other biocompatibility testing and, combined, might reduce the need for animal testing. This draft guidance is intended to update the methods for distinct types of devices and give recommendations on how manufacturers can apply analytical chemistry testing for a particular medical device. Manufacturers of medical devices that require biocompatibility testing should read this document about the latest FDA views on analytical chemistry testing and update their biocompatibility plan, as needed.
Learn more about FDA US Medical Device Registration.
Family Grouping for In Vitro Diagnostic Medical Devices
I. Key Points:
II. Gap Analysis Between IN 320/2024 and IN 03/2015:
Conclusion:
IN 320/2024 enhances the regulation of family groupings for in vitro diagnostic devices, providing a detailed, structured approach that meets current regulatory needs while preserving key prohibitions.
Learn more about ANVISA Brazil Medical Device Registration.
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As 2024 comes to a close, Pure Global proudly reflects on a transformative year marked by substantial growth, cutting-edge innovation, and impactful collaborations.
IVD manufacturers cite the new classification system, detailed definitions for intended purposes, and the need for verification of clinical evidence as key challenges under the IVDR.
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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.
Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.