GOOD REGULATORY REVIEW PRACTICES WORKING GROUP UPDATE. Working Group Chair: Melissa Torres US Food and Drug Administration
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1 GOOD REGULATORY REVIEW PRACTICES WORKING GROUP UPDATE Working Group Chair: Melissa Torres US Food and Drug Administration
2 GOALS The Good Regulatory Review Practices working group has focused efforts on harmonizing premarket requirements in alignment with the IMDRF strategic priority to improve the effectiveness and efficiency of premarket review. IMDRF/GRRP WG/N40FINAL:2017 Competence, Training, and Conduct Requirements IMDRF/GRRP WG (PD1)/N47 Essential Principles of Safety and Performance Labeling and Instructions for Use Requirements 2
3 CURRENT WORK ITEMS New Work Item Proposals March 2017: Approved to revise GHTF/SG1/N68:2012 Essential Principles of Safety and Performance of Medical Devices to create a new/updated IMDRF document outlining essential principles that can be used as a foundation for creating a more harmonized premarket review process. September 2017: Approved to revise GHTF Label and Instructions for Use for Medical Devices (GHTF/SG1/N70:2011) in conjunction with the Essential Principles document to update to reflect current labeling and instructions for use requirements. 3
4 CURRENT STATUS IMDRF GRRP WG(PD1)/N47 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices Face to face working group meeting in Silver Spring, MD in December 2017 Document approved during the January IMDRF MC teleconference for public consultation for a period of 90 days GHTF Label and Instructions for Use for Medical Devices (GHTF/SG1/N70:2011) Draft document created Working through teleconferences 4
5 ESSENTIAL PRINCIPLES: KEY CHANGES Updated based on EU MDR, ISO 16142, and other jurisdictional requirements. Streamlined medical device and IVD medical device requirements. Updated requirements in areas such as SaMD, cybersecurity, performance characteristics of IVDs, etc. Removal of the majority of labeling principles and ensure coverage in label and instructions for use document. Addition of an Annex outlining the importance in the use of standards to assist in meeting EPs. Linkage of EPs to relevant guidances and standards to assist in meeting particular EPs. 5
6 Essential Principles of Safety and Performance Medical Devices and IVD Medical Devices General Clinical Evaluation Chemical, Physical, and Biological Properties Sterility, Packaging, and Microbial Contamination Considerations of Environment and Conditions of Use Protection against Electrical, Mechanical, and Thermal Risks Active Devices and Devices Connected to Them Software or SaMD Diagnostic or Measuring Function Labeling and Instructions for Use Protection against Radiation Protection against Risks posed by Devices for Use by Lay Persons Devices Incorporating Materials of Biological Origin Devices Incorporating a Substance Considered to be a Medicinal Product/Drug Medical Devices Chemical, Physical, and Biological Properties Protection against Radiation Requirements for Implantable Medical Devices Protection against the Risks Posed to the Patient or User by Medical Devices Supplying Energy or Substances IVD Medical Devices Performance Characteristics Chemical, Physical, and Biological Properties 6
7 RELATIONSHIP WITH STANDARDS AND GUIDANCES 7
8 LABEL AND INSTRUCTIONS FOR USE DOCUMENT Updating based on EU MDR, IMDRF GRRP WG(PD1)/N47, ISO CD 20417, and jurisdictional requirements. For example: Streamlining medical device and IVD medical device requirements Updating requirements in areas such as SaMD, UDI, etc. Inclusion of labeling concepts from EP document 8
9 GRRP AND STANDARDS IMDRF Good Regulatory Review Practices working group continues to coordinate work with: IMDRF Standards working group ISO TC210 WG 2 General aspects stemming from the application of quality principles to medical devices CD Medical Devices Information to be provided by the manufacturer ISO (Part 1 and Part 2) Medical Devices Recognized essential principles of safety and performance of medical devices Proposal to have a joint meeting between ISO TC210 WG 2 and IMDRF GRRP in May 2018 to work on finalizing EP and draft Label and Instructions for Use documents 9
10 TIMELINE April Public consultation period for EPs closes Teleconferences May June July/ August Face to face working group meeting to address EP public comments and finalize draft Label and Instructions for Use document Submit Label and Instructions for Use document to MC Draft Label and Instructions for Use document to be considered for a 60 day consultation period during MC teleconference Submit EP and Label and Instructions for Use document to MC Sept. Final EP and Label and Instructions for Use documents to be considered during MC meeting 10
11 THANK YOU
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