Health Technology & CE-HTM Regulation

P. Grainger & F. Martinez

Li Bin (China)
Ajai Basil & Mohammad Ameel (India)
Nicolas Pallikarakis (Greece)
Adriana Velazquez-AV (WHO, Switzerland)
Antonio Hernandez & Tobey Clark (USA)
Nancy Pressly (USA FDA)
Ashenafi Hussein (Africa)

Project Summary

Network with existing global & national HT Regulation stakeholders to influence CE-HTM role inclusion in HTR.

Key Objectives

1. Survey global/national HT Regulation stakeholders in 2019 re CE-HTM role inclusion;

2. Participate with WHO influence in global IMDRF http://www.imdrf.org/;

3. Create a global HTR White Paper by 2021 recommending strategic harmonized CE-HTM role in various global HT Regulations

Completed Milestones

1. Initial White Paper outlining scope of project created 2018 (PG) – copy available;

2. Created experienced Project team to address Survey (2019), Analysis (2020), and future global CED White Paper to influence CE-HTM role inclusion in global HTR (2021);

3. CED began IMDRF official observer role (PG) with WHO assistance (AV) at March IMDRF 2019 meeting to begin to give ‘voice of CE-HTM in global HT Regulator discussions’.

4. HT Regulation project in 2019:

- Identify CED project collaboration areas; plan HTR global Questionnaire, to send in 2nd half of 2019
- Identify existing relevant bodies of regulation where possible, and develop CED network and linkages
- 3 working groups of IMDRF where CED could best contribute/collaborate, eg, to be the 'voice of CE': (1) Adverse Events; (2) Linkage of Standards & Regulations; and (3) Cybersecurity.

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