Regulatory convergence of medical devices: a case study using ISO and IEC standards.

INTRODUCTION

Achieving regulatory convergence is important in providing safe and effective medical devices to patients in a timely manner. The use of standards set by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), may be an important tool for regulatory convergence. The International Medical Device Regulators Forum (IMDRF) published a survey and statements regarding the use of these standards in each IMDRF jurisdiction, which showed that each jurisdiction proactively uses these standards in its regulation.

AREAS COVERED

This review describes the current situation by comparing the ISO and IEC standards with regulations in the European Union, the USA, and Japan on the basis of third-party certification in Japan.

EXPERT COMMENTARY

Our results show that ISO and IEC standards may be important tools for regulatory convergence. However, the corresponding Technical Committees and publication editions vary in each regulation. Furthermore, there are cases in which inconsistencies between the requirements of these standards and regulation may arise. Considering this background, it is important that jurisdictions have common consensus about which Technical Committees are appropriate for the regulation of medical devices and the importance of involving standards development at an early stage to reflect regulatory opinions.