An extensive round-up of medical device regulatory news from November 2024 includes new and updated guidance documents, Q&As, and directives from Europe and the US, including the new EU Product Liability Directive for AI and Smart Products.
This is part of the legislative process; the European Parliament approved it on 17 September 2024 and the European Council formally adopted it on 10 October 2024.
The product liability rules are good news for consumers and producers because it will become easier for an injured person to claim damages in court. Manufacturers benefit from clearer rules and legal clarity for producers. It includes specific rules reflecting the increasing digitalisation of the economy and society and intends to integrate smart products and systems with artificial intelligence (AI). It is embedded in a regulatory system, which includes the General Product Safety Regulation, the revised Ecodesign Directive (with the Right to Repair Directive), and the AI Liability Directive.
Under the new EU Product Liability Directive, products that have been modified after being placed on the market will fall under the modifier’s responsibility and liability. Further, economic operators (e.g., importer, distributor) involved in the supply chains will be liable, too.
Many controls and obligations are like obligations defined in the MDR/IVDR. Manufacturers and economic operators of non-medical devices now will need to prepare carefully and check their responsibilities within the supply and distribution chains.
The new EU Product Liability Directive will apply from the fourth quarter of 2026 onward.
On 23 October 2024, the EU published the Cyber Resilience Act, establishing horizontal cybersecurity requirements for products with digital elements. Applicable to all connected products, the regulation enhances security across industries, excluding medical devices and IVDs, as these are already governed by MDR/IVDR and relevant standards like IEC 81001-5-1. This act ensures robust protection for digital ecosystems while maintaining alignment with existing sector-specific regulations.
13 November 2024 – Key discussions at the MDCG In Vitro Diagnostic Medical Devices subgroup meeting included SARS-CoV-2 device classification, performance study Q&A, health institution definitions, and distance sales. A highlight was the COMBINE program, addressing challenges in combined studies to streamline regulatory compliance. The official report remains pending publication.
A new 28-page questionnaire, jointly published by IG-NB and Team NB on 13 November 2024, offers a detailed overview of AI-related regulations in the context of MDR and IVDR. Designed in accordance with MDGG 2022-14, this document cross-references relevant regulations and provides manufacturers with a comprehensive guide to current state-of-the-art standards and guidance for AI-driven medical devices. While it does not yet address the specific AI Regulation 2024/1689, it paves the way for future revisions in this evolving field.
This MDCG document clarifies the general obligations of sponsors to submit final reports to competent authorities in EU Member States when conducting clinical investigations. This is defined under MDR Article 77(5) MDR. Though not new, the guideline clarifies the obligations to submit the required reports irrespective of the outcome of the clinical investigation. It further defines how the report and summary shall be submitted by means of EUDAMED and how they shall become publicly accessible through EUDAMED (publicly available CIRCABC directory).
In November 2024, a new Q&A document was released to guide the gradual roll-out of EUDAMED under the amended MDR and IVDR regulations (EU 2024/1860). This document clarifies the obligations related to six EUDAMED modules, which will be activated six months after the official confirmation of their functionality. It also addresses requirements for notifying interruptions or discontinuations of supply and includes transitional provisions for specific in vitro diagnostic medical devices. The guidance ensures a smoother transition as manufacturers and economic operators prepare for the full implementation of EUDAMED.
In November 2024, the MDCG released an updated version of guidance document MDCG 2023-3 rev.1, clarifying vigilance terms and concepts under the EU Medical Devices Regulations (MDR) and In Vitro Diagnostic Devices Regulations (IVDR). The revised document includes new Q&As, harmonizing with other EU legislation and adding specific examples, flowcharts, and guidance on handling erroneous results for IVDs. This update provides enhanced clarity for manufacturers and regulators on vigilance reporting requirements.
In November 2024, the MDCG released guidance on the implementation of the Master UDI-DI solution for contact lenses, which are classified as highly individualised devices. The document outlines specific interpretations for assigning the Master UDI-DI (MUDI) and Basic UDI-DI (BUDI), addressing the hierarchical structure and unique requirements for these devices under the EU Medical Device Regulation (MDR). This guidance helps ensure proper UDI implementation for contact lenses to maintain regulatory compliance.
Learn more about EU Medical Device Registration.
This open consultation initiated from MHRA is inviting members of the public (patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public) to provide their views on proposals to update the regulatory framework for medical devices. The MHRA is collecting the view of on four areas: International reliance, UKCA marking, in vitro diagnostic devices and assimilated EU law. Feedback can be provided online until 5 January 2025. 2 Documents are attached to this notification, a draft of “Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices (44 pages) and a Consultation survey questions (13 pages).
Learn more about MHRA UK Medical Device Registration & Approval.
The FDA added the following standards to the Recognized Consensus Standards database, which will soon appear in the Federal Register, but manufacturers may cite them now:
New guidance documents (published by CDRH, Office of Product Evaluation and Quality, Office of Health Technology VI - Orthopedic Devices) provide the FDA’s recommendations on information to support premarket submissions for orthopedic non-spinal bone plates, screws, and washers. A significant part of this guidance is for adequate predicate information to be included in a 510(k). The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of orthopedic non-spinal bone plate, screw, and washer submissions. These guidance documents have been included in the federal register.
This guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program (3P510k Review Program) and third-party review of Emergency Use Authorization ((3PEUA Review) requests by describing FDA's expectations for the review of 510(k) submissions and EUA requests by third party review organizations. This guidance provides updated recommendations on the 510(k) Third Party Review Program and supersedes the "510(k) Third Party Review Program" guidance.
Because this guidance clearly describes and distinguishes FDA’s expectations for the 3P510k Review Program and for 3PEUA review, it is recommended to be read by all manufacturers, who intend to use third parties for review. The guidance has been included in the federal register.
In November 2024, FDA published a Notice to provide an enforcement discretion policy to help proactively address manufacturing limitations or supply chain issues due to disruptions caused by closures or potential closures of sterilization facilities that use EtO as a medical device sterilant during the time in which manufacturers are transitioning to compliance with certain new requirements. This guidance provides information regarding FDA recommendations and general principles to be referenced by holders of premarket approval applications (PMAs) and humanitarian device exemptions (HDE) for class III devices sterilized by ethylene oxide (EtO) whose products are affected by the potential, actual, or temporary stop or reduction of operations at a sterilization facility, if they wish to have FDA consider whether the exercise of enforcement discretion relating to the implementation of certain types of sterilization site changes is appropriate.
Learn more about FDA US Medical Device Registration.
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