Period: Feb – May 2019
Client: Web-Based Application Software
Subject: Class IIa Medical Software
The software is intended to support efficient clinical decision making by providing the healthcare professional with clinically relevant information, clinical decision-support and embedded analytics.
Our Task Was
As per Medical Device Regulation (EU) 2017/745, Annex VIII, Chapter III, Classification Rules, Clause 6, Active Devices, Sub-clause 6.3, Rule 11, Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa.
- Evaluation based on Scientific Literature Currently Available
- Demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate (if yes, then considerations as per Medical Device Regulation (EU) 2017/745, Article 61, Clause 10 should be included)
- As per Medical Device Regulation (EU) 2017/745, Annex I, Clause 8, “All known and foreseeable risks, and any undesirable side-effects shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use”
- Since the device has low risk and does not come in direct contact with the patient, clinical side-effects are not applicable to this device and clinical data cannot be obtained through PMCF. Hence PMCF is not important to demonstrate the conformity of the device to general safety and performance requirements.
- Therefore under Article 61, Clause 10 of MDR, we are claiming exemption from PMCF and demonstrating the acceptability of undesirable side-effects.
As this is medical software application, biocompatibility testing and electrical safety testing is not required. The number of adverse events and side-effects reported are very less and rare when compared to the number of patients who benefit from the device use. The device helps the healthcare providers to give effective diagnosis, treatment and care for patients, thereby improving their performance and the patient outcome. The various literatures selected also show that the benefits of device outweigh any risks posed by it.
Hence it can be concluded that clinical information system web-based application software support is beneficial to healthcare professionals and patients, and that it is conforming to the requirements on safety, benefit/ risk profile, performance and acceptability of side-effects.