1-2. Purpose and Scope
Source: MDCG 2020-1 (March 2020), pages 3-4
1. Purpose
The purpose of this guidance is to provide a framework for the determination of the appropriate level of CLINICAL EVIDENCE required for MEDICAL DEVICE SOFTWARE (MDSW) to fulfil the requirements set out in Regulation (EU) 2017/745 – Medical Devices Regulation (MDR) and Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Devices Regulation (IVDR).1
In order to promote global convergence, this document takes into account certain concepts outlined in International Medical Device Regulators Forum (IMDRF) guidance documents (such as N41).2
2. Scope
This guidance should be applied to MDSW. For the purpose of this guidance, MDSW is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a "medical device" in the medical devices regulation or in vitro diagnostic medical devices regulation.
It should be noted that software can be associated3 with another medical device, by driving or influencing its use. The guideline MDCG 2019-11 clarifies that software which is driving or influencing is covered by the medical devices regulations4 either as a part/component of a device or as an accessory for a medical device.
Software developers should refer to MDCG 2019-11 for guidance on the appropriate qualification and classification of software prior to such software being introduced into the market. The same principles of CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) apply to all MDSW. Conceptually, the following models of software can be understood (whereas combinations may be possible, refer to Table 1):
a) Software for which the manufacturer claims a specific medical intended purpose. Such software has a CLINICAL BENEFIT and requires CLINICAL EVIDENCE within its own conformity assessment.
b) Software for which the manufacturer does not claim any medical intended purpose. Such software is intended to drive or influence a medical device. The CLINICAL EVIDENCE is provided within the context of the driven or influenced device and is therefore out of the scope of this document.
It should be recognised that the concept of a CLINICAL BENEFIT for MDSW may deviate from that which applies in the case of pharmaceuticals or other medical devices, since the benefit of MDSW may lie in providing accurate medical information on patients, where appropriate, assessed against medical information obtained through the use of other diagnostic options and technologies, whereas the final clinical outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be available.
| Model of Software | CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) - scope |
|---|---|
| MDSW (with independent intended purpose and claimed CLINICAL BENEFIT) | MDSW only |
| MDSW (with intended purpose and claimed CLINICAL BENEFIT related to driving or influencing a medical device for a medical purpose) | MDSW and the driven or influenced medical device Notes 1,2 |
| Software driving or influencing the use of a medical device (with no independent intended purpose or independent claimed CLINICAL BENEFIT) | Driven or influenced medical device including the software (component or accessory) |
Table 1 Different MDSW and CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) requirements
Note 1: If a software is driving/ influencing more than one medical device, an independent CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) is required for each foreseen and clinically viable software – device combination.
Note 2: Out of scope of this guidance (See MDCG 2019-11 for examples).