To kick off 2025, we bring you a round up of medical device regulatory updates from across Europe and the US, including a new position paper from TEAM-NB on MDR certification processes and numerous guidance updates from the US FDA.
The Team-NB members adopted a paper describing in detail the pre-application, application, and post-application phases through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). Appendix A includes a List of data/documents to be submitted by the manufacturer at various phases of the process.
Though the requirements are not new, this position paper is the first combined document that summarizes and illustrates certification activities that are undertaken by NBs for the application process. It describes the different “Stages of the Certification Process,” as well as the associated controls (documents) to be checked for each application stage by NBs. The stages are:
Though this position paper refers to MDR only, the same approach might be taken for IVDR as well.
After a period of five years, the MDCG 2019-13 “Guidance on sampling of MDR Class IIa /Class IIb and IVDR Class B / Class C devices for the assessment of the Technical Documentation“ was slightly revised to MDCG 2019-13 Rev.1. Only a minor formal update was made to footnote 10 relating to the sampling plan for Notified Bodies (number of devices sampled). Numbers are not affected.
Various sections of MDCG 2022-3 guidance “Verification of manufactured Class D IVDs by Notified Bodies” has been revised to add clarification on timelines and information in testing plans for product batches (batch testing). The clarifications on batch testing specifically express that “the concept of batches is not applicable for medical device software.” For calibrators and controls, the testing frequency should follow the testing plan of the corresponding device(s)/reagent(s).
The Member States endorsed the strategy for the second phase of the EU COMBINE Programme, which is a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics. The published ‘COMBINE’ programme strategy describes the next phase. With the analysis phase completed in May 2024, the project is moving into its second phase – the development and implementation of solutions. The vision statement for the COMBINE programme is as follows:
The COMBINE programme seeks to make the European Union an attractive region to conduct combined studies, envisioning a clear and smoothly functioning regulatory environment for combined studies through broad involvement of regulators, ethics committees and all impacted stakeholders, with the goal to support availability of innovative treatments for patients.
This press release summarizes the status and progress to the full implementation of performance and batch verification of class D devices EURL testing activities. The progress is specifically related to the standardization of documents used for both batch release and performance verification, including contract templates, test requests and reports. It further summarizes how the formal agreement and workflow between the Notified Bodies and the EURLs for Class D devices can be managed to finalize a quick and compliant implementation of the requirements for Performance Verification and Batch testing activities as been mentioned in article 100 of the IVDR, e.g., with the MSA template.
Learn more about EU Medical Device Registration.
With the entry into force of the amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO), Switzerland is implementing extended transitional periods in line with the EU Regulation and delays from various amendments made; this specifically refers to extended transition timelines (e.g., extension of the validity of certificates issued under the old legislation in the EU to 2027, 2028, or 2029, or obligations for healthcare institutions using in-house devices) and gradual roll-out of EUDAMED. This restores regulatory equivalence with the EU.
The amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO) enters into force on 1 January 2025. Registration of devices will be mandatory from 1. July 2026.
Learn more about Switzerland Medical Device Registration.
These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) to insert clearer and risk-proportionate new post-market surveillance requirements that improve the safety of medical devices across Great Britain. This statutory instrument was necessary to improve the ability of both manufacturers and the MHRA to identify issues with medical devices and take timely action. The requirements in the new PMS regulations closely resemble those already established in the EU MDR and the EU IVDR. However, they are not identical. The requirement to maintain a PMS system, based on the PMS plan for each device placed on the market, is the same. However, MHRA has chosen to use divergent definitions from the EU for clarity or global alignment with IMDRF and other guidelines. Therefore, manufacturers marketing in UK and EU should align their quality procedure for PMS and related PMS activities against the UK legislation.
Following a six-month implementation period, this legislation will come into force in summer 2025.
The AI Airlock Pilot Program was launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products. The pilot scheme, AI Airlock, is designed to help test and improve the rules for AI-powered medical devices to ensure they reach patients quickly, safely, and effectively. The update for the pilot program adds “five innovative AI technologies as part of pilot scheme to change regulatory approach" and enhance the understanding of and accelerate solutions to novel regulatory challenges for AIaMD:
Learn more about MHRA UK Medical Device Registration & Approval.
FDA published a final rule establishing a unique device identification system (UDI Rule) on September 24, 2013; it required that specified product information be submitted to FDA’s Global Unique Device Identification Database (GUDID). This guidance document provides the FDA's recommendations on the information necessary for labelers submitting data to GUDID. FDA has updated this document to reflect changes to the Global Medical Device Nomenclature (GMDN) field in GUDID. The option to use FDA Preferred Terms (FDA PT) Codes are removed because FDA PT codes are no longer necessary since GMDN Terms are now available without a paid membership.
This guidance serves as the baseline for information about notifications under section 506J during or in advance of any public health emergency (PHE). This guidance includes a list of devices by FDA product code for which a manufacturer of such devices is required to notify FDA in accordance with section 506J of the FD&C Act. Additionally, FDA has clarified that manufacturers may submit, and FDA may receive, voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency.
This draft guidance document provides the FDA’s recommendations regarding non-clinical and clinical performance testing to support premarket submissions for pulse oximeters for medical purposes, including devices with a pulse oximeter function that estimates the amount of oxygen in arterial blood and pulse rate. The recommendations are being provided to inform the performance evaluation for these devices, to support premarket submissions, regardless of submission type, and to promote consistency and facilitate efficient review of these submissions.
This draft guidance describes general recommendations for the validation of IVDs for emerging pathogens during an applicable declaration under section 564 of the FD&C Act. These recommendations apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered under an applicable enforcement discretion policy. A generic template is also being made available through download from FDA’s website, which reflects FDA’s current thinking on validation study recommendations.
This draft guidance document provides recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA’s evaluation of safety and effectiveness. The recommendations reflect a comprehensive approach to the management of risk throughout the total product life cycle (TPLC).
This draft guidance provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to determine the safety or effectiveness of a device. The purpose of this guidance is to encourage science-driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the device, when designing medical device clinical studies and reporting data from such studies in accordance with legal requirements.
Learn more about FDA US Medical Device Registration.
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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.
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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.
