post-market and market surveillance guidance -link with
TRANSCRIPT
www.who.int
Workshop on Post-market surveillance and market surveillance for regulators of medical devices including in vitro diagnostics
15 November 2021
Post-market and market surveillance guidance - Link with other WHO tools
WHO Global Model Regulatory Framework for medical devices including IVDs
Guidance for Post market and market surveillance of medical devices including in vitro diagnostics
GBT Plus Medical devices
Linkage between the tools
Outline
The WHO Global Model Regulatory Framework for Medical Devices including IVDs…. Introduction
ü Published by WHO in 2017; on going review
• Intended for National Regulatory Authorities (NRAs)
• Scope: Medical devices including in vitro diagnostics
• Revision: August 2021 to February 2022
• Revision involves WG members: WHO (SG and Secretariat), Medical devices and IVDs regulators and other experts who are non regulators.
• Status: Discussions of the WG-On going followed by Regional Workshops and public consultation (s) in Q2 of 2022.
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ü WHO GMRF was developed in 2015-2016 and published in 2017 (5th year)
ü Rapidly changing field (technology, update of guidance documents such as PMS & MS, GRP, GRelP, discussions during integration of MDs indicators into the GBT, regulator`s experience during implementation and COVID-19 pandemic.
ü Member States will benefit from an update
The WHO Global Model Regulatory Framework for Medical Devices including IVDs…. rationale for the revision
ü Good Regulatory Practice;
ü Reliance and recognition, including exchange of information amongst NRAs;
ü Nomenclature system and UDI;
ü Regulatory pathways for medical devices according to their risk class;
ü Regulatory pathways for exemptions and emergency authorization;
ü Regulatory pathways for borderline products;
ü Regulatory pathways for donated medical devices;
ü Policy and implementation of testing medical devices;
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The WHO Global Model Regulatory Framework for Medical Devices including IVDs…. topics to expand
Ø On risk assessment in priority-setting of the current situation regarding regulation of medical devices;
Ø Steps for implementation: e.g., how to prioritize;
Ø Start implementing regulatory controls;
Ø Guidance on developing a road map;
Ø New technologies such as software as a medical device (including cybersecurity);
Ø How to involve stakeholder i.e., industry and civil society
Ø Regulatory capacity building
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The WHO Global Model Regulatory Framework for Medical Devices including IVDs…. Guidance
§ All medical devices, including IVDs
§ Without prejudice to national legislation
§ Describes
§ Post-market surveillance activities for manufacturers
§ Feedback procedure for users
§ Market surveillance activities for regulators
§ Specific considerations for WHO-recommended IVDs (PQ, EUL, etc.)
§ Language? English but expected to be translated to at least 6 UN languages.
What does the guidance cover?
https://www.who.int/health-topics/substandard-and-falsified-medical-products#tab=tab_1
What new elements have been introduced
§ Reflects new international standards/guidance
§ Medical devices – post-market surveillance for manufacturers, ISO/TR 20416:2020
§ IMDRF terminologies for categorized adverse event reporting (AER); terms, terminology structure and codes, IMDR/AE WG/N43
§ Revised criteria and timelines for manufacturers to report to NRAs, without prejudice to national legislation
§ Terminology clarity/shifts
§ “Post-market surveillance” for manufacturers
§ “Market surveillance” for NRAs
§ “User feedback” rather than “complaint”
The WHO Global Model Regulatory Framework for Medical Devices including IVDs…. key points related to PMS/MS
Basic Level: (supported by law, regulations and guidance documents)
o System for receiving feedback (complaints ) from the market (who, where and when).
o FSCA: Mandatory reporting of FSCA by the manufacturer.
o Enforcement of regulations through FSCA and withdraw unsafe medical devices (safety of the public comes first), quarantine, warning letters suspension/revocation of establishment of product certificate.
o Issuance of safety alerts to users or the public esp. serious adverse events e.g.
o Market surveillance: targeted activities to monitor safety and performance based on risk assessment of the distribution chain.
Market Surveillance (2019/2020 WHO survey)
Out of the 26 NRAs, 6 (23%) have reported not having market surveillance requirements .
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SAD ReportingQD
Recalls Withdraw FSCA Safety Alerts None All elements
Market Surveillance
WHA Resolution 67.20 on strengthening regulatory systems for medical products, endorsed in May 2014.
WHO global benchmarking tool (GBT):ümeans by which WHO evaluates regulatory system; responsible for the regulationof medical products;
üenable the WHO and regulatory authorities to identify strengths and areas forimprovement;
üfacilitate the formulation of an institutional development plan (IDP) to build uponstrengths and address identified gaps;
üprioritization of investments in IDP implementation; and
ühelp monitor progress.
WHO GBT Plus medical devices
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WHO GBT Plus medical devices…………….
• The current GBT Rev VI covers only medicines, vaccines and blood and blood products
• Revision of the tool to integrate medical devices and IVDs indicators into the GBT was initiated end of last year. The work involved WG members: WHO, Medical devices and IVDs regulators and laboratory experts and other MDs experts who are non regulators.
• Discussion : 1 September 2020 to June 2021.
• Status: Editorial work and publishing in Q4.
• Pilot: Q1 of 2022
WHO GBT Plus medical devices
Medicines indicators
2013
Blood and Blood
Products indicators
2019
GBT Plus
Medical devices
indicators2020
Vaccines indicators1997
§ 1997 = Vaccines assessment tool. § 2013 = Unified WHO Global Benchmarking
Tool (GBT) for the evaluation of medicine and vaccine
• 2019 = Blood and blood products• 2020 = Medical devices and in vitro
diagnostics (ongoing……….)These developments now provide for a single consolidated tool with flexibility to assess different product related regulatory systems.
Agreed amendments and finalization of the tool (editorial and publishing of the tool)
Working Group discussions
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Integration of medical devices into WHO GBT………… 2020Mar
2020
Revised Matching Exercise (WHO)
Apr 20
20
May to
Aug
202
0
Working group remote meetings (WHO and NRA experts) (ToRsincluding timelines)
Working group discussion postponed
GBT+MD piloting
Sept
2020
to J
an
2021
Q4 20
21
Q1 202
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Post market & market surveillance guidance role in the GBT Plus medical devices
GBT+Medical devices
Post market & market surveillance guidance role in the GBT Plus medical devices
GBT+Medical devices
Basic and Expanded levels of control for medical devices has three broad groups:- those applied before a medical device is placed onthe market;
- those applied when placing the device on themarket,
- those applied after the device has been placed onthe market. Market surveillance
NRAs
GBT functions:- 27 sub indicators under
Market Control &Surveillance;
- 26 sub indicators underthe Vigilance
Adoption or utilization of the guidance document:
- effective mechanism to monitor safety and performance of medical devicespost registration
- Identification and action against SF devices
- align procedures based on internationally accepted standards and
guidelines.
- Implementation of GBT indicators
