Software classification in the sense of Medical Device Regulation (MDR)
Software for the prediction or prognosis of diseases continues to count as a medical product in the sense of MDR.
If software is used for the prediction or prognosis of diseases, it continues to count as a medical device in the sense of the MDR. In many cases, however, and depending on the purpose of the software, a higher classification is very likely, even for apps.
The MDR Rule 11
Software that controls a product or influences its application is assigned to the same class as the product. If the software is independent of other products, it is classified separately:
- Software used to control physiological processes (=class IIa), except:
- it is intended for the control of vital physiological parameters, the nature of which could lead to an immediate danger for the patient (=class IIb)
- Software that is intended to provide information for decision-making for diagnostic or therapeutic purposes (=class IIa), unless such decisions have following implications:
- may cause a serious deterioration in a person's state of health or surgical intervention (= Class IIb)
- may cause death or irreversible deterioration in a person's state of health (= Class III)
- any other software is assigned to Class I
Note on Class I software
Almost any software is designed to provide information that in any sense serves to make decisions for diagnostic or therapeutic purposes.
While stand-alone software still frequently fell into Class I when classified according to the Medical Devices Directive (MDD), this is changing with MDR. Software is usually defined here as Class IIa or higher.
This means that a considerable proportion of software will be upgraded. Manufacturers are faced with major challenges in this regard: It is not only necessary to set up a QMS and implement the requirements of the MDR - e.g. for technical documentation and clinical evaluation - but also to find a notified body that has the necessary resources for timely certification.
We therefore recommend all manufacturers to at least begin certification according to DIN EN ISO 13485:2016 as soon as possible in order to have at least demonstrably implemented the requirements of the QMS. Ideally, you as the manufacturer should cooperate with a certification body that is also the notified body for the Scope MD 1111 (software). The Berlin Cert is the notified body for this scope and will be happy to assist you with any questions you may have. If you would like an individual offer, simply fill out the offer form on our website, send us an e-mail or give us a call.