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

Regulatory convergence of medical devices: a case study using ISO and IEC standards. Expert Rev Med Devices. 2018 Jun 23;: Authors: Imagawa K, Mizukami Y, Miyazaki S Abstract 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 United States 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 regul...
Source: Expert Review of Medical Devices - Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research