Action point 17 - Strategy to support capacity building to regulate medical devices, including IVDs

One of the main objectives of SEARN is dedicated to ‘facilitate and support regulatory capacity development to enhance regulatory skills and competencies and strengthen regulatory systems in the region’. Capacity building was also one of the most common demands from the working groups during their meetings in January 2022 and from the Steering group in its March 2022 meeting.

To address this need, the Assembly adopted on 27 July 2023 a Strategy to support capacity building. However, this strategy does not address medical devices, and these products are not included in the scope of the WHO Global Competency Framework for Regulators of Medicines.

Further, a Review of the gaps in Medical Devices regulation was conducted during the 2022-2023 work plan, which highlighted specific challenges and needs.

Considering the specificities of medical devices regulation, the Assembly created in 2023 a dedicated action point (AP17) in the SEARN workplan, led by Working Group 5 (WG5) Medical devices.

Draft a strategy to support capacity building to regulate medical devices, including IVDs, and achieve their objectives of Maturity Level.

As per the Strategy to support capacity building, the key principles guiding the development of this strategy are the following:

• The outcome of the capacity building strategy should benefit all Members of SEARN
• The strategy should rely on existing resources and only develop a new capacity building offer in areas where there are unmet needs
• The capacity building offer should be sustainable and predictable so NRAs can consider it in their training strategies
• The capacity building outcomes should be documented

The following paragraphs were developed based on the work conducted during the 2022-2023 work plan as part of the development of the Strategy to support capacity building.

While the concept of capacity building (later replaced by capacity development) has often been used synonymously with training and technical assistance, these are only some of several approaches to developing capacity (1).

The United Nations Sustainable Development Group (UNDG) defines capacity as ‘the ability of people, organizations and society as a whole to manage their affairs successfully’ and the United Nations Development Programme (UNDP) has defined capacity development as ‘the process through which individuals, organizations and societies obtain, strengthen and maintain the capabilities to set and achieve their own development objectives over time’ (2,3).

The UNDP identifies 3 inter-related levels to capacity development (2):

• Individual—improving individual skills, knowledge and performance through training, experiences, motivation and incentives;
• Organizational—improving organizational performance through strategies, plans, rules and regulations, partnerships, leadership, organizational politics and power structures, and strengthening organizational systems, processes, and roles and responsibilities
• Enabling environment—improving policy framework to address economic, political, environmental and social factors including economic growth, financing, labour markets, political context, policy and legislative environment, class structures, and cultural aspects in a coherent and mutually reinforcing fashion.

Specifically, the World Health Organization (WHO) has established a Regulatory System Strengthening (RSS) programme which uses the Global Benchmarking Tool (GBT) to identify strengths as well as areas for improvement, and develop Institutional Development Plan (IDP). In this context, this strategy generally encourages the Members of SEARN to use the GBT to strengthen their regulatory systems for all medical products. Of interest, the GBT defines competency as follows: ‘Competency combines knowledge, skills and attitude. Competencies describe how the work is to be carried out while objectives indicate what must be accomplished. They also provide a sound basis for consistent and objective performance standards by creating a shared language for what is needed and expected by the organization’.

This strategy focuses on:

• Individual capacity development
• Organizational capacity development, in complement to the WHO Regulatory System Strengthening (RSS) programme.

The initial identification of the needs of the SEARN members, to support the further discussions, was based on:

• A review of the needs identified in 2019 for medical devices
• The results specific to medical devices which were collected as part of the survey on capacity building needs of SEARN members conducted during the 2022-2023 work plan
• The review of the gaps in Medical Devices regulation was conducted during the 2022-2023 work plan, which highlighted specific challenges and needs.

Please also refer to the frameworks identified in the Strategy to support capacity building.

In addition, the following frameworks were deemed relevant to this strategy:

Global Competency Framework for regulators of medicines

The WHO Global Competency Framework for Regulators of medicines outlines competence criteria for pharmaceutical regulators and investigators.

While the scope does not include medical devices regulation, it was one of the main references of the work conducted during the 2022-2023 work plan as part of the development of the Strategy to support capacity building. It may also be helpful to refer to the initial concept note published in 2019: ‘Towards a global competency framework for regulators of medical products, WHO Drug Information Vol 33, No. 1, 2019.

The global competency framework is designed to identify critical gaps in the professional development and capacity of regulatory personnel. The framework provides performance indicators across a variety of national regulatory functions, including the regulatory governance framework, marketing authorisation/ reviewers, regulatory inspection, vigilance and surveillance, and laboratory analysis.

It is described in more details in the original document and summarised in the Strategy to support capacity building.

The Global Model Regulatory Framework (GMRF) for Medical Devices

The WHO has developed the Global Model Regulatory Framework (GMRF) for Medical Devices including in vitro diagnostic medical devices (IVDs) to provide guidance and support to WHO Member States that have yet to develop and implement regulatory controls relating to medical devices, as well as to jurisdictions that are continuing to improve their regulatory frameworks as they take steps to ensure the quality and safety of medical devices available in their countries.

Especially, the model has proposed a step-wise approach to regulating medical devices, which differentiates:

• Basic level controls and their enforcement (legal basis, premarket, placing on the market, postmarket), for which general technical expertise on medical devices is recommended;
• Expanded-level controls (premarket, placing on the market, postmarket), for which some regulatory staff would also need to have more specific technical expertise.

Overall, the model identifies that ‘general competencies for regulatory professionals include an understanding of public health principles, analytical and communication skills, information handling and skills in effective intervention and crisis management. (…) Additional specific competencies include essential knowledge of the regulatory system for medical devices, the responsibilities of the regulator, the concepts of international standards and harmonization, and an understanding of a range of different device technologies and their application. (…) As the regulatory system and its implementation become more comprehensive, additional resources will be required. In view of the importance of the manufacturer’s QMS, the authority should recruit and train staff members with experience in that field’.

Guidance for post-market surveillance and market surveillance of medical devices

The Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics (3) recommends a regulatory model which put more emphasis on the role of manufacturers than in the traditional notification/reporting system which was established for medicines and vaccines.

Considering that many countries heavily rely on importations to access medical devices, it may also be important to keep in mind the particular role of other economic operators such as importers, distributors and authorized representatives, who play an important supportive role to ensure feedback from users reaches the manufacturer, including overcoming language barriers in this model.

Depending on the type of use, the pathway may involve a direct report from the user (e.g. laboratory technician) or pass by a healthcare professional (e.g. experience from a patient).

While the focus of this strategy is National Regulatory Authorities, taking actions to build and maintain awareness and capacity of other stakeholders, such as through engagement with associations, is critical to the effectiveness of the regulatory system.

Identified countries’ tailored goals

Based on the results from the Review of the gaps in Medical Devices regulation conducted during the 2022-2023 work plan, three groups of countries with specific goals were identified. These goals were further discussed in the drafting group and working group to ensure consensus:

• Adequate legal framework
• Reliance only
• Maturity Level 3 against the Global Benchmarking Tool.

Individual level

Derived from the global competency framework for regulators of medicines, a competency framework has been developed in the prioritized area of pre-marketing activities, focusing on:

• Role-specific activities for Reviewers:
  • Data review on quality, safety, effectiveness/performance
  • Product labelling, including information for use
  • Reliance and regulatory decision-making
• Role-specific competencies for reviewers
  • Data review on quality, safety, effectiveness/performance
  • Product labelling, including information for use

SEARN Competency framework for medical devices (premarketing)

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The framework will serve as a basis for identifying pre-existing offers covering the needs, as well as unmet needs, (please refer to Action point 1 Capacity building) and should be published on the website of SEARN. Medical devices should be further considered as part of the overall capacity building strategy (e.g. the development of an online interface, the mapping of existing training resources or the identification of Regional Centres of Excellence.

Organizational level

To support capacity building at the organizational level, the following actions are recommended:

• To facilitate information sharing of sharing of SOPs, guidelines, legal provisions between SEARN Members (please refer to action point 3 Information Sharing)
• To support efforts of regulatory convergence for medical devices

1. Conduct a regional workshop on strengthening medical devices regulation
2. To expand the competency framework
3. To support the implementation of the capacity building strategy
4. To support regulatory convergence and explore participation in international networks and organizations