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EU Guide: Medical Device Accessories under the MDR/IVDR
14 May 2024The International Medical Device Regulators Forum (IMDRF) released eight new guidance documents:
- Principles of Labelling for Medical Devices and IVD Medical Devices
- Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
- Medical Device Regulatory Review Report: Guidance Regarding Information to be Included
- Competence, Training, and Conduct Requirements for Regulatory Reviewers
- Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
- Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
- Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Review
- Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews
Overview
These documents are intended:
- To improve the efficiency and effectiveness of the regulatory review process.
- Encourage and support global convergence of regulatory systems.
- To identify the type of information a Conformity Assessment Body (e.g., Notified Body) would be expected to review.
- To establish, in a consistent way, an economic and effective approach to the control of medical devices.
- To strike a balance between the Regulatory Authorities’ responsibilities to safeguard the health of their citizens, while avoiding placing unnecessary burdens upon the industry.
They were drafted to be consistent with the other product submission guidance, e.g., regulatory submission Table of Contents (ToCs), Assembly and Technical Guide for ToCs, and Common Data Elements for Medical Device Identification.
This is part of the IMDRF’s focus on international reliance to streamline the premarket process for both regulators and manufacturers.
The full list of IMDRF members, official observers, and affiliate members can be found: HERE
Principles of Labelling
Guidance ‘IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)’ provides an overview of labelling requirements. It includes some practical guidance, such as:
- Examples of when the label information can be provided on the packaging of each unit versus on the device itself.
- As best practice, only one machine-readable format should be on the label; however, if there are multiple, it should be clear which to scan when and for what purpose.
- The manufacturer’s address should contain the physical location and include the country.
- Imported devices should contain the name and physical address of the importer (if required by that IMDRF jurisdiction); this information may be added by the importer within the country of import, rather than be provided by the manufacturer prior to shipment.
- How the expiration date should be identified, e.g., ideally as the full year, month and day as it provides the least ambiguity.
- The Instructions for Use should include the manufacturer’s contact information to obtain technical assistance, e.g., telephone number, website, or email address (if required by that IMDRF jurisdiction).
- The Instructions for Use should state the date of issue or latest revision, and where appropriate, an identification number.
- As best practice, Instructions for Use for lay users should include pictorial representations of all possible test results, including when a device has failed to provide a valid result, where the device gives a visual readout.
The guidance is broken down between general medical devices, IVDs, and short sections on software, devices intended for lay users, and information intended for the patient, e.g., implant cards and brochures.
Principles of Safety & Performance
Guidance ‘IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2)’ discusses the general principles of Safety & Performance. This includes:
- Establishing a risk management system that is ongoing and continually updated, and
- Other considerations, such as related to chemical, physical, and biological properties, or sterilization and microbial contamination.
The reviewer will assess if the device was designed and manufactured in a way to reduce risks in all of the applicable areas. For example, to reduce the risk of user error, or ensure they are packaged in a way to minimize the risk of microbial contamination.
Medical Device Regulatory Review Reports
Guidance ‘IMDRF/GRRP WG/N71 FINAL:2024’ discusses contents of the Regulatory Review Report. This document is the written record of the Conformity Assessment Body’s decision, e.g., recommendation for certification.
It includes information such as:
- The use of “N/A” should not be used without an accompanying rationale, e.g., the device does not contain software, or detailed quality management procedure may not be required for US 510(k) submissions.
- The report does not have to include a detailed listing of the history of interactions with the manufacturer; this can be in an appendix or maintained as a separate resource available to support the conclusions of the review.
- The report should pay special attention to whether all product labeling (packaging, IFU, promotional materials, etc.) is consistent with the information in the regulatory submission.
Remaining Guidance Documents
The other guidance documents cover:
- Qualification and training criteria for both Conformity Assessment Body reviewers (e.g., Notified Bodies) and the Regulatory Authority personnel responsible for assessing the Conformity Assessment Bodies.
- The minimum requirements for Conformity Assessment Bodies, including legal, liability insurance, structural/organizational, resource and process requirements.
- Methodology to screen and qualify Conformity Assessment Bodies, including grading of non-conformities.
- The Regulatory Authority’s process and scope, for conducting assessments of Conformity Assessment Bodies.
Further Reading
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