Medical Devices Industry Updates Newsletter September 2024

MHRA Updates Guidance on Assistive Technology: Definition and Safe Use

On September 6th 2024, Medicines & Healthcare products Regulatory Agency updated Guidance on Assistive technology: Definition and Safe Use

The guidance aims to help manufacturers, healthcare professionals, and users understand what constitutes assistive technology and how it differs from medical devices and aids for daily living.

Definition and Scope:

Assistive technology includes products or systems designed to support individuals with disabilities, restricted mobility, or other impairments in performing functions that might otherwise be difficult or impossible.

The document clarifies that not all assistive technologies are medical devices. A product is considered a medical device only if it is intended for a medical purpose as stated by the manufacturer.

Regulatory Framework:

The guidance outlines the regulatory requirements for assistive technology products, including the need for conformity marking and adherence to the UK Medical Devices Regulations 2002 (as amended).

It also highlights the differences in regulations between Great Britain and Northern Ireland.

Examples and Safety:

• The document provides examples of assistive technologies and common safety issues associated with their use.
• It emphasizes the importance of proper labeling, instructions for use, and adherence to safety standards to ensure the safe use of these products.

This guidance is a valuable resource for anyone involved in the development, regulation, or use of assistive technology. It provides clear definitions, regulatory insights, and practical advice to ensure the safe and effective use of these essential products.

MHRA Published a Policy Paper on its Strategy to Improve Safety Communications.

On September 17th 2024, Medicines & Healthcare products Regulatory Agency published Policy paper on MHRA Strategy for Improving Safety Communications.

The MHRA’s strategy for Improving Safety Communications for 2024 to 2027.

Introduction

The strategy aims to transform MHRA’s communication methods to ensure that healthcare professionals and patients receive timely, coordinated, and impactful safety information. This initiative is based on feedback from healthcare professionals and organizations, emphasizing the need for effective communication to support patient safety.

Background

MHRA’s role as the regulator of medicines, medical devices, and blood components for transfusion in the UK is to ensure these products are safe and effective. The agency uses science and data to inform its decisions and supports medical innovation while maintaining high standards of safety, quality, and efficacy.

Safety Communications

The document stresses the importance of transparent and effective communication about the risks and benefits of medical products. Key objectives include:

• Providing timely information about newly identified risks.
• Explaining necessary actions to protect patient safety.
• Supporting healthcare professionals in making informed decisions.
• Maintaining public confidence in medical products and the healthcare system.

Strategic Goals

The strategy outlines several goals to improve safety communications:

• Enhancing Communication Channels: Utilizing various platforms to reach a broader audience, including digital and social media.
• Targeted Messaging: Developing tailored messages for specific audiences, such as healthcare professionals, patients, and the general public.
• Collaboration and Feedback: Engaging with stakeholders to gather feedback and improve communication methods continuously.
• Training and Support: Providing resources and training for healthcare professionals to ensure they can effectively communicate safety information to patients.

Implementation Plan

The strategy includes a detailed implementation plan with specific actions and timelines. This plan focuses on:

• Developing new communication tools and resources.
• Enhancing existing platforms and channels.
• Regularly reviewing and updating communication strategies based on feedback and new data.

Conclusion

The MHRA’s strategy for improving safety communications is a comprehensive plan aimed at ensuring that all stakeholders receive accurate and timely information about the safety of medical products. By leveraging modern communication tools and engaging with healthcare professionals and patients, the MHRA aims to enhance patient safety and maintain public trust in the healthcare system.

This strategy represents a significant step forward in how safety information is communicated, reflecting the MHRA’s commitment to protecting public health through effective and transparent communication.

Swissmedic has Recently Published Information Sheet on Combined Studies.

Identification number: BW600_00_017 Version: 1.0

This information sheet is intended for sponsors, contract research organizations (CROs), and investigators involved in combined studies. It outlines the regulatory requirements and procedures for obtaining authorization from Swissmedic.

Terms and definitions:

The term ‘combined study’ has not yet been formally defined in a Swiss or European regulation. For the purpose of this information sheet, combined studies can be understood as studies that involve: ▪ A clinical trial of an MP / ATMP in parallel with an interventional performance study of an IVD ▪ A clinical trial of an MP / ATMP in parallel with a clinical investigation of a MD

Objective and Introduction:

The document aims to clarify the unique aspects of combined studies, including their submission for authorization and conduct.

It provides a comprehensive introduction to the legal basis, standards, and guidance documents relevant to combined studies.

Authorization Process:

Detailed steps for applying for the authorization of a combined study are provided, including the review and authorization process.

The document explains the procedures for submissions involving multiple sponsors and confidentiality restrictions.

Modifications and Reporting:

Guidance on handling amendments that affect combined studies and the re-categorization of clinical trials is included.

The document also covers reporting duties during combined studies, such as annual safety reports and the handling of serious adverse events.

This guidance is a valuable resource for those involved in combined studies. It offers clear instructions and regulatory insights to ensure compliance with Swissmedic’s requirements. The document is well-structured and provides practical advice for navigating the complexities of combined studies.

Swissmedic Urges Review of Legacy Devices Complying with Old Legislation

Swissmedic To Swiss authorised representatives and importers: Request to review devices that comply with the old legislation / legacy devices. Bern, 18.09.2024.

Reference

Swissmedic addresses the upcoming expiration of important deadlines for legacy medical devices, which are devices that comply with the old legislation. These deadlines are set for September 26, 2024. However, the document clarifies that, under certain conditions, these devices may continue to be marketed until 2027 or 2028.

Applicability

The transitional provisions apply to all devices that comply with the old legislation and for which the manufacturer is seeking certification under the EU Medical Device Regulation (EU-MDR). The document emphasizes that each device must be individually evaluated to ensure compliance with the transitional provisions.

Verification and Due Diligence

Swissmedic outlines the responsibilities of authorized representatives and importers in verifying and documenting the conformity of legacy devices. This includes:

• Self-declaration by the manufacturer: Confirming that the conditions for placing devices on the market are met.
• Confirmation letter from the designated/notified body: Stating that a written agreement has been signed before the deadline.

Actions for Non-compliance

If the conditions for the transitional provisions are not met, the devices cannot be placed on the market. Importers and authorized representatives must ensure conformity before marketing the devices. This may involve changing or terminating mandates with manufacturers or preventing the placement of non-compliant devices on the market.

Feedback to Swissmedic

The document states that there is no need to provide feedback to Swissmedic regarding the review of legacy devices. However, it is the responsibility of economic operators to ensure compliance. Swissmedic retains the authority to inspect devices on the market at any time.

Additional Information

Swissmedic provides references to further information, including detailed obligations for economic operators and European Commission guidelines. This ensures that stakeholders have access to comprehensive resources to understand and comply with the transitional provisions.

The document emphasizes the importance of due diligence, individual evaluation of devices, and adherence to regulatory requirements to ensure that only compliant devices are placed on the market. This proactive approach by Swissmedic aims to maintain a safe and effective medical device market in Switzerland.

USFDA Releases Guidance on Study Data Technical Conformance – Technical Specifications Document

On September 16th 2024, USFDA published a Guidance Document on Study Data Technical Conformance Guide - Technical Specifications Document

The “Study Data Technical Conformance Guide” is a comprehensive resource designed to help sponsors and applicants prepare and submit study data that meets FDA standards. By following the guidelines, stakeholders can ensure that their data submissions are accurate, consistent, and ready for regulatory review.
Reference

The guide outlines the FDA’s current thinking on the technical specifications for study data submissions. It aims to facilitate the submission of standardized data to support regulatory review and decision-making processes.

Contents

• Data Standards: Emphasizes the use of standardized data formats and terminologies to ensure consistency and facilitate data integration and analysis.
• Submission Requirements: Provides detailed instructions on the required formats, structures, and content for study data submissions, including specifications for datasets, variables, and controlled terminologies.
• Validation and Quality Control: Outlines procedures for validating study data to ensure accuracy, completeness, and compliance with FDA standards. Includes recommendations for quality control checks and validation rules.
• Technical Specifications: Details specific technical requirements for electronic data submissions, including file formats, naming conventions, and metadata requirements.
• Data Integration and Analysis: Offers guidance on preparing data for integration and analysis by the FDA, including the use of standardized datasets and variables.

Implementation

The guide encourages sponsors and applicants to follow these specifications to streamline the submission process and improve the efficiency of regulatory reviews. It highlights the importance of early planning and coordination with the FDA to address any technical issues that may arise during the submission process.

Contact Information

For questions or alternative approaches, the guide provides contact information for the FDA staff responsible for implementing the guidance.

CDSCO Seeks Stakeholder Feedback on Draft GCP Guidelines

CDSCO invites stakeholders comments on the draft GCP guidelines. September 12th 2024.

GCP compliance is mandatory as per the New Drugs & Clinical Trials Rules, 2019 in the clinical studies of new drugs. Reference

The said draft guidelines has been published on CDSCO website for your comments/suggestions within period of 30 days by email to dci.nic.in.

An expert committee constituted under the Chairmanship of Prof Bikash Medhi, PGIMER has prepared this draft in consultation with the stakeholders. The primary objective of the GCP is to protect the rights, safety and wellbeing of the Clinical Trial participants.

Introduction

The guidelines emphasize the ethical and scientific standards required for conducting clinical research, ensuring the safety, rights, and well-being of participants.

Definitions

This section provides definitions for various terms used in clinical research, such as adverse events, bioavailability, bioequivalence, and investigational products.

Prerequisites for the Study

• Investigational Pharmaceutical Product: Documentation of the product’s properties and formulation.
• Pre-clinical Supporting Data: Adequate data to support the proposed study.
• Protocol: Detailed protocol including objectives, ethical considerations, study design, and safety assessments.

Responsibilities

• Sponsor: Ensures the study is conducted according to GCP, manages data, and provides necessary resources.
• Investigator: Conducts the study, ensures participant safety, and maintains accurate records.
• Ethics Committee: Reviews and approves study protocols, monitors ongoing studies, and ensures ethical standards are maintained.

Record Keeping and Data Handling

• Documentation: All steps in data management should be documented.
• Corrections: Proper procedures for correcting data.
• Electronic Data Processing: Ensuring data integrity and security in electronic systems.

Quality Assurance

• Quality Control: Ensuring data reliability through monitoring and audits.
• Risk Management: Identifying and managing risks throughout the study.

Statistics

• Study Design: Importance of randomization and blinding.
• Statistical Analysis: Methods for analyzing data and reporting results.

Special Concerns

• Clinical Study of Vaccines: Phases of vaccine studies and specific guidelines.
• Clinical Study of Contraceptives: Ethical considerations and follow-up.
• Clinical Study with Medical Devices: Regulatory requirements and safety assessments.

Disclosure of Site-Specific Safety/Efficacy Data

Guidelines for reporting safety and efficacy data to regulatory authorities and ethics committees.

Appendices

• Appendix I: Declaration of Helsinki.
• Appendix II: New Drugs and Clinical Trials Rules, 2019.
• Appendix III: Animal Toxicology Studies.
• Appendix IV: Conduct of Clinical Study/Research.
• Appendix V: Information to be Submitted by an Applicant.
• Appendix VI: Format for Submission of Preclinical and Clinical Data.
• Appendix VII: Essential documents for the conduct of a clinical study/research