MDR Rule 11 – influencing software
identified as medical devices with full force
MDR Rule 11 – influencing software identified as medical devices with full force
In 2015, 58% of all smartphone users according to a survey of the NYU Langone Medical Center have downloaded a health app, this trend was increasing over the years. The market is booming but the quality and regulation is yet not quite understood by manufacturers, authorities, and customers. With the new Medical Device Regulation coming into effect in May 2020, a high standard and more actions as well as accountabilities from the software developers are required than ever before. But when exactly is a software identified as a medical device? What are the impacts this new regulation will have on such software which are classified as medical devices?
According to MDR the intended use given by the software manufacturer is pivotal to identify if the software is a medical device or not. For example, when the manufacturer claims, that a greater wellbeing or an improvement of the fitness can be achieved by using that software, it is not a medical device. However, when the manufacturer claims, that a disease will be opposed, then it is a medical device. These identifications via intended use were also applicable prior to the MDR. Though, as soon as a software is identified as a medical device, new and stronger regulations will now come into effect (=> MDR Compliance). Software as medical devices are furthermore classified into four classes to identify their immediate danger potential, ranging from class I with no danger to patient’s safety, about class IIa and IIb, and ending into class III for potential deadly harm. Due to Rule 11 of the MDR software is a medical device as soon as they provide information for decision making with diagnosis and/or therapeutic purposes and/or to monitor physiological processes. Per default, each software will then be classified as class IIa, unless it may cause serious injury (IIb) and/or death (III) resulting in a higher classification. Interestingly, that rule strengthens the word «may» which opens up leeway to interpretation about what causes harm to patient safety. Although the legal text further reveals, that there is a class I for software, until now no identification of such software is even possible. With this loosely interpreted rule, each software, which is a medical device, can be classified at least as class IIa implying stronger regulations such as a certified quality management system (EN ISO 13485), the need of clinical trials, a technical documentation, and a post-market surveillance. The risks for software manufacturer here are on the one hand the uncertainty of software classification and on the other hand the upgrade from class I to class IIa.
As seen in the results section, MDR has a strong influence on software identified as medical devices not only the software itself but also on the manufacturer by stronger requirements for compliance.
Friday, 22 November 2019, 10:30-11:15 a.m.
No time on this appointment? Then register anyway and secure your access data for the free podcast! You will receive it automatically shortly after the webinar.
This webinar is aimed at specialists and executives from the fields of quality management / assurance and IT for companies in the regulated environment (pharmaceuticals and medical technology).
CONTENT OF THE WEBINAR
- Regulations regarding software classified as medical devices
- Classification of software as medical devices
- MDR Rule 11
- Challenges for companies regarding the new rule
- Strong know-how in classification of software as medical devices
- Over 15 years of industry know-how in the validation of computerized systems
- Over 15 years of consulting know-how in risk management
- Lessons learned from many successful validation projects in the GxP environment
- Interactive exchange with our experienced consultant and other webinar participants
The webinars are online seminars. All you need to participate is a PC with an Internet connection and speakers. Alternatively, the sound can also be transmitted via telephone, while you can follow the image presentation via your browser. The webinars are interactive, i.e. you can ask questions at any time.
PARTICIPATION AND REGISTRATION
The webinar will be held in English language (without translation).
Our webinars are a free service for DHC customers and prospects.
IT service providers and consultants are excluded from participation.
The number of participants is limited. Please reserve your webinar seat below:
After registration you will receive a confirmation email with all information about the participation in our webinar.