What is it all about?
Generally, state-of-the-art (SOTA) means the most recent, advanced, sophisticated, and innovative version of technological developments. However, for medical devices, given the myriad of Regulatory documents and definitions, SOTA meaning changes. As per the MDCG, SOTA represents what is currently and generally accepted as good practice in technology and medicine. It is sometimes referred to as the ‘generally acknowledged state-of-the-art’. The IMDRF defines SOTA as a developed stage of current technical capability and/or accepted clinical practice in regard to products, processes, and patient management, based on the relevant consolidated findings of science, technology, and experience. The EU MDR 2017/745 refers SOTA to technology, characteristics, performance, transport, storage, risk management, safety and performance, and PMS activities.
The main aim of all the MDRs is to bring the safest and most performing devices to the market. But, with many SOTA explanations, the medical device manufacturers, and Notified Bodies (NBs) are confused on what exactly SOTA refers to. Is it the medical device, or the techniques used to build them, or the analytical methods and clinical trials conducted to test them? Are you a medical device manufacturer longing to access the EU market? Have you evaluated your device’s SOTA for the EU MDR compliance? Do you know the importance of SOTA in the EU?
To assist you in better understanding the importance of SOTA for medical devices in the EU MDR, we are presenting you with an exclusive webinar on:
Compliance and Beyond: Your State-of-the-art Guide in EU MDR
Kristen Laudicina is the Vice President of Strategic Account for Freyr’s Medical Devices Center of Excellence (CoE). She currently oversees the North and South American Regions and supports Freyr’s Medical Device CoE team. Kristen has 12+ years of experience within Life Sciences, from Preclinical through Commercial Manufacturing, and understands the client’s needs from both a sponsor and service provider perspective.
As a subject matter expert in medical writing and with more than eight (08) years of experience in Medical Devices, Priya Ray Chaudhuri has successfully spearheaded project deliveries for a range of clients, including prominent global IVDR and MDV market leaders. She is passionate about leveraging her expertise in delivering tailored solutions that exceed expectations.
Kristen Laudicina -
Vice President of Strategic Account, Medical Devices, Freyr
Priya Ray Chaudhuri -
Subject Matter Expert, MDV Medical Writing, Freyr