Software Regulated as a Medical Device in the EU and the US
04 Apr 2011
Software also may be regulated as a medical device in the European Union (EU). The definition of a medical device in the latest version of the Medical Device Directive now specifically lists software as a medical device if it is intended by the manufacturer to be used for one or more of the medical purposes set out in the definition. Apparently, a MEDDEV guidance document is under development to help determine classification in the EU, which in turn drives conformity assessment options. The "Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices" version 1.8 includes a section on Picture Archiving and Communication Systems (PACS). According to this, a PACS may fall under class I, class IIa or Class IIb, depending on its intended use. The EU also agrees with Canada in that PACS that are only intended for archiving or storage of data do not fall within the definition of a medical device provided that data is not manipulated.
Some type of software also is regulated as a medical device by the FDA in the US and classification may vary from Class 1 to Class 3.
The IEC 62304 standard "Medical device software – Software life cycle processes" was developed for the benefit of software developers who are producing software that is considered a medical device in major markets such as Canada, the US and the EU and who must demonstrate the safety and effectiveness of their software.
Regardless of the classification, a key element that software developers must implement is a risk management system. One framework many device manufacturers have used to manage risk, which software developers are now discovering, is to establish a documented risk management system according to the ISO 14971 standard. In our April 18 blog, we'll talk more about ISO 14971 and how it can be used to evaluate and control potential risks.
To speak with an Intertek expert on this subject matter, please send an e-mail to us at askmedical@intertek.com.