Regulatory Affairs

March 2019

IEEE Standards for Medical devices with measuring function

EAMBES Councilor for Regulatory Affairs and Treasurer, Almir Badnjevic, proposed new standards for Medical devices with measuring function. He formed a group of expert who will work in the next few years on new IEEE Standard for medical devices with measuring function. The first drafts are made for P2727: Standard for General Vocabulary for Conformity Assessment of Medical Devices with Measuring Function and P2727.1: Standard for Conformity Assessment Testing of Cardiac Defibrillators for Legal Metrology Purposes.

March 2019

EAMBES part of IV WHO Global Forum on Medical Devices

Members of EAMBES, Almir Badnjevic and Leandro Pecchia, took very active role in organization of Forth WHO Global Forum on Medical Devices which was  held in Visakhapatnam, Andhra Pradesh, India from 13 to 15 December 2018.

Our members organized many sections in the field of Regulation of Medical devices and Health Technology Assessment. Also, they had many invited lectures, workshops and posters.

Some of presented papers and organized sessions are:

Assessment of medical devices: IFMBE HTA methods

Nomenclature and classification of medical devices

Management of medical equipment

Regulation of medical devices

3D printing, AI and design of medical devices for low resource settings

Metrology of medical devices

More about IV WHO Global Forum on Medical Devices can be found at: https://www.who.int/medical_devices/global_forum/4th_gfmd/en/

April 2018

Book - Inspection of Medical Devices - for Regulatory Purposes

EAMBES Councillor for Regulatory Affairds, Almir Badnjevic, together with his team published a unique book titled: Inspection of Medical Devices – for regulatory purposes. The book is published by Springer. 

This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations.

Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.

More about the book: https://www.springer.com/us/book/9789811066498