IVDR requirements for SOFTWARE
Software fulfilling the definition of an in vitro diagnostic medical device falls under the In vitro diagnostic medical device regulation (EU) 2017/746 (IVDR). In the past, several of these are self-certified or not covered under IVDD. Provided that MDSW is intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable it to be used in accordance with its intended purpose, this MDSW falls under the scope of the In vitro diagnostic medical devices regulation and shall be treated as an In Vitro Diagnostic MDSW (IVD MDSW) in its own right.
Classification and implementing rules as per IVDR 2017/746
All implementing rules, Annex VIII of Regulation (EU) 2017/746 shall be considered.
Special considerations on Implementing Rule 1.4 and 1.9:
Implementing rule 1.4 is only applicable for software which drives or influences the use of an in vitro diagnostic medical device. This rule should also be considered at least as an orientation for finding the right classification of software which is placed on the market in combination with a hardware medical device.
According to implementing rule 1.4, if the software is independent of any other device, it shall be classified in its own right. Implementing rule 1.9 states that if several classification rules apply to the same device based on the devices intended purpose, the rule resulting in higher classification will apply.
In determining the proper classification of MDSW under the IVDR, the manufacturer shall consider all classification and implementing rules of Annex VIII of the IVD Regulation (EU) 2017/746. As spelled out by Implementing Rule 1.1 of Annex VIII of Regulation (EU) 2017/746, the application of the classification rules shall be governed by the intended purpose of the MDSW.
General Principles and Context of SaMD Clinical Evaluation Process
SaMD can best be described as software that utilizes an algorithm (logic, set of rules, or model) that operates on data input (digitized content) to produce an output that is intended for medical purposes as defined by the SaMD manufacturer. The risks and benefits posed by SaMD outputs are largely related to the risk of inaccurate or incorrect output of the SaMD, which may impact the clinical management of a patient.
Software verification and validation
Include IVD software life-cycle documentation and related procedures (e.g. software development plan, software requirements specification, software architecture, software detailed design, software unit testing procedures/reports, software integration testing procedures/reports, software system testing, software maintenance, software risk management, configuration management, problem resolution)
A manufacturer must have a technical file that demonstrates the conformity of their standalone software with the respective provisions of the applicable regulations.
Functions of In vitro diagnostic medical device software
Software normally supports the following functions:
- Ordering of laboratory tests, samples with labels and sorting.
- Technical and clinical validation, connection to analytic instruments.
- Laboratory results and reports on paper fax or electronic records that can be directly returned the ordering clinic’s patient record.
- Analytical instruments can be interfaced with Hospital Information Systems (HIS), Electronic Patient Record Systems, Infectious control databases, etc.