Keep up to date on the most recent developments in the EU regulatory landscape for the medical device sector. Explore our thorough overview of recent updates, encompassing fresh standards, legislative measures, and advisory materials. Delve into the details now to ensure compliance.
The UK has recently introduced a new set of guidelines detailing an innovation framework specifically designed for the medical technology industry. These guidelines are structured around four primary goals:
- To develop a unified language to facilitate discussions about innovation within the medical technology sector.
- To establish definitive criteria that categorize a medical device as innovative, acknowledging various forms of innovation.
- To articulate the differences and advantages of the innovative device relative to existing market options, emphasizing patient and system benefits.
- To assist in the prioritization and adoption of innovations that have the most significant impact.
This guidance document outlines specific criteria for defining innovation in medical technology, including incremental, transformative, and disruptive innovations, supported by relevant case studies. Additionally, a classification flow chart is provided in the appendix to aid in understanding and applying these criteria.
The framework is designed to serve multiple purposes, such as evaluating suitability for funding and other support mechanisms aimed at fostering various types of innovation. It also plays a crucial role in the assessment of cost-effectiveness and qualification for national framework agreements, which facilitate market access.
Moving forward, the next six months will involve collaborative efforts with key partners such as the MHRA, NHS England, NHS Supply Chain, and NICE. These partnerships aim to test the framework’s implementation and effectiveness across different stages of the innovation pathway. After this period, feedback will be solicited to assess the relevance and practicality of the framework, ensuring it meets the needs of stakeholders and contributes to the advancement of medical technology.
The Swiss Medic information sheet, now in its third version, provides updated guidance on the regulatory framework for medical device software (MDSW) in Switzerland, emphasizing its classification and oversight under the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). This third version outlines the EU and Swiss legal frameworks, including necessary MDCG guidelines and technical standards like EN 62304 andEN ISO 14971. Highlighting new amendments, the document details enhanced responsibilities for economic operators and specifies stricter protocols for product identification, including compliance with labeling and the Unique Device Identification (UDI) system. The updates also address the evolving landscape of distance sales and the usage of medical software within healthcare institutions, ensuring compliance with both Swiss and EU regulatory framework throughout the distribution chain and within healthcare institutions.
A recent study has been conducted to assess the implementation of Article 17 under the Medical Device Regulation (MDR), focusing on how its provisions are being applied across various European countries and their operational effectiveness. The study started in December 2022 and was performed over 14 months. In support of this study, a specialized dashboard has been created. This dashboard serves two primary purposes:
- Providing a Comprehensive Overview: It displays a detailed mapping of the study’s activities, offering insights into the various aspects being examined and the methodologies used. This feature allows stakeholders to grasp the scope and depth of the investigation, ensuring transparency and a clear understanding of the study's framework.
- Displaying Study Results: The dashboard systematically presents the findings of the study, highlighting key data points and trends observed during the analysis. This visualization aids in the interpretation of complex data, making it accessible and understandable for all stakeholders involved. The results are laid out in a manner that facilitates quick assimilation of how Article 17 provisions are functioning in real-world settings across Europe.
This interactive tool is essential for monitoring the effectiveness of MDR implementation and provides valuable insights that can guide future regulatory decisions and amendments. It also serves as a resource for regulatory bodies, medical device manufacturers, and healthcare providers, offering them a detailed view of the current regulatory landscape and its impact on medical device governance. Through this dashboard, users can easily navigate through the data, enhancing their understanding and ability to make informed decisions based on the study’s outcomes.
The update of MDCG 2022-9 Rev.1 document provides detailed guidelines for the Summary of Safety and Performance (SSP) that medical device manufacturers must adhere to under Regulation (EU) 2017/745 and Regulation (EU) 2017/746. These regulations ensure that comprehensive safety and performance summaries are publicly accessible via the European database on medical devices (Eudamed). The SSP is crucial for bothclass C and D devices, excluding those for performance studies, and must be validated by a notified body.
Key updates in MDCG 2022-9 Rev.1:
- Clarity on availability: the revision clarifies when the SSP should be made available to patients, particularly emphasizing its necessity for self-testing devices and when considered relevant by the manufacturer.
- Content reorganization: information that was previously under specific sections has been restructured to improve coherence. For instance, details regarding devices for near-patient testing and companion diagnostics have been moved to enhance logical flow and accessibility.
- Terminology modifications: the term "Intended use of the device" has been expanded to "Intended purpose and other indications," allowing for a more extensive description that accommodates a broader range of device functionalities and uses.
- Regular updates: the revision emphasizes the need for periodic evaluations to determine if updates to the SSP are necessary based on insights gained from the Post-Market Performance Follow-Up (PMPF) and the Periodic Safety Update Report (PSUR). This ensures that the SSP remains current and reflective of ongoing safety and performance assessments.
- User-specific information: the SSP template differentiates the information for professional users and laypersons/patients to ensure that all user groups receive appropriately tailored information. For devices not intended for self-testing, the SSP focuses on professional users, while a separate section is dedicated to laypersons when relevant.
- Inclusion of comprehensive details: the document includes extensive details about the device such as identification, risk class, descriptions, any accompanying devices or accessories, and regulatory statuses that ensure a thorough understanding of the device’s use and safety.
- Performance and safety summaries: sections are dedicated to summarizing the scientific validity, performance data, any field safety corrective actions, and ongoing post-market surveillance that are vital for ensuring the device’s continued efficacy and safety post-market.
The MDCG 2024-4 document outlines comprehensive safety reporting requirements for in vitro diagnostic (IVD) medical devices under the IVDR (In Vitro Diagnostic Medical Device Regulation) during performance studies. This guidance is crucial for ensuring that safety data from performance studies are systematically reported to regulatory bodies across Member States.
Key elements of MDCG 2024-4:
- Clarifications and definitions: the document clarifies 23 definitions crucial for reporting, such as Adverse Device Effect (ADE), Anticipated Serious Adverse Device Effect (ASADE), and more, ensuring that all stakeholders have a uniform understanding of terms.
- Reporting procedures: detailed processes for reporting adverse events during pre-market performance studies are outlined. This includes transitioning to the electronic system EUDAMED, which, while not yet fully functional, will ultimately streamline reporting processes.
- Reportable events and exceptions: the guidance specifies which events need reporting and the exceptions, particularly noting the conditions under PMPF (post-market performance follow-up) studies falling under IVDR Article 70(1).
- Roles and responsibilities: it delineates responsibilities for various stakeholders, including sponsors and investigators, ensuring that reports are timely and accurately submitted to the appropriate national competent authorities (NCAs).
- Timelines and formats: specific timelines for reporting serious adverse events and device deficiencies are set. The document emphasizes the use of a standardized reporting form (found in the appendix), which facilitates consistency across reports.
- Causality assessment: guidelines for assessing the causality of reported events are provided to help determine if an event is directly related to the device, comparator, or study procedures.
- Transitional provisions: the guidance accommodates the current transition phase towards full EUDAMED functionality, detailing interim procedures for reporting in the absence of the Eudamed module.
As mandated by Article 70(1) of the MDR, this updated guidance document on Investigator's Brochure (IB) accompanies clinical investigation applications to ensure full disclosure of technical and clinical device data. This document aids sponsors in preparing the IB to fulfill the detailed requirements of Chapter II, Annex XV of the MDR, aligned with ISO 14155:2020 standards for clinical practice.
The key information contained in IB is:
- Device information: the IB should detail the device’s identification, intended purpose, risk classification, design, and manufacturing. Information on previous and similar device generations should be included to illustrate the evolution and rationale behind the current design.
- Labeling and documentation: it must encompass instructions for use (IFU), labels, training materials, and an implant card where applicable. These components should ensure the device's safe and effective use, presented in a clear and non-promotional manner.
- Pre-clinical and clinical data: the brochure should summarize the pre-clinical evaluations and existing clinical data demonstrating the device’s safety and effectiveness. It must also include detailed descriptions of the methodologies used and the results of these evaluations.
- Risk management: a comprehensive strategy for managing identified risks, potential adverse effects, and device-specific considerations should be discussed. This section should detail the anticipated serious adverse events and device effects, supported by a robust risk-benefit analysis.
- Regulatory compliance: emphasize compliance with the General Safety and Performance Requirements (GSPR) to align with EU MDR. The brochure should clearly outline the fulfillment of these requirements, referencing any standards or specifications applied.
The European Commission has welcomed the adoption by the European Parliament of new measures to enhance the availability of in vitro diagnostic (IVDs) devices for patients and healthcare providers. These measures, proposed in January 2024, aim to ease the transition to the new EU rules on IVDs by allowing additional time based on the device's risk level. For instance, high-risk devices like HIV tests have until December 2027, moderate-risk devices like cancer tests have until December 2028, while lower-risk devices like pregnancy tests have until December 2029.
In addition, the measures introduce a mandate for manufacturers to notify national authorities and the healthcare sector (e.g.,distributors, healthcare professionals) six months in advance if they anticipate any supply disruptions. This is intended to mitigate risks of shortages and ensure continuity in patient care.
Finally, the gradual implementation of the European Database on Medical Devices (Eudamed) starting from 2026 will enhance transparency and provide a comprehensive view of medical devices available in the EU market.
The European Parliament’s approval of these measures clears the path for the Council to officially implement the regulation, creating a stronger and more transparent regulatory framework for medical devices and IVDs within the EU.
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