MDCG Offers Flood of Guidance on Software, Class I Transitional Provisions and More
The EU’s Medical Device Coordination Group (MDCG) released two new guidances and two updated guidances on Tuesday, offering device firms and notified bodies more details on what clinical evidence and performance evaluation is required for software under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), as well as further guidance on Class I device transitional provisions, and new versions of guidance on implant cards and unique device identifiers (UDIs).The 21-page software guidance deals with the type of software that involves a manufacturer claiming a specific medical intended purpose and clinical benefit, which requires clinical evidence within its conformity assessment. But software that is intended to drive or influence a medical device is outside the scope of this guidance.
“Clinical expertise and judgments are required at every step of the CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR), including literature search and appraisal. Each indication and claimed CLINICAL BENEFIT that is part of the intended purpose should be assessed individually and have the supporting CLINICAL EVIDENCE. Systematic and explicit approach for the appraisal of supporting data allows achieving confident, scientifically substantiated conclusions and facilitates transparency of these judgments,” the guidance says.
The document offers the example of software that detects heart arrhythmia by analyzing “auscultation sound obtained by a digital stethoscope,” noting that software would require “demonstrating VALID CLINICAL ASSOCIATION of the association between abnormal cardiac sounds and heart arrhythmia.” Further examples are included in the annex.
To determine and justify the level of clinical evidence, the guidance adds that both amount and quality of supporting data should be evaluated. Companies should ask questions like: “Does the data support the intended use, indications, target groups, clinical claims and contraindications?” or “Was the statistical approach appropriate to reach a valid conclusion?”
In a section on technical and analytical performance, the guidance notes that the identification of gaps during the validation of such performance could require the generation of new evidence, for example, to demonstrate generalizability “with real-life datasets or to extend the usability evaluation to omitted user groups.”
The guidance further explains how if software is used for the determination of a patient’s future state (e.g. predisposition, prognosis or prediction) or if the output of the software impacts clinical outcomes (e.g. treatment efficacy) or patient management decisions, then a prospective study may be required as part of the device’s clinical evaluation (MDR) or performance evaluation (IVDR).
In addition, the guidance discusses the continuous updates of such clinical and performance evaluations.
Transitional Provisions and Updated Guidance
The MDCG also released guidance on Tuesday outlining information to be provided in the form of a Declaration of Conformity by manufacturers of Class I devices (devices which are non-sterile or do not have a measuring function) that are required to have MDR certificates after 26 May 2024.
Article 120(2) and 120(3) of MDR states that devices which have a valid certificate issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR under certain conditions and no later than 26 May 2024.
The Declaration of Conformity allows the manufacturer to declare that the products concerned meet the relevant provisions of the MDD.
“Necessary amendments/updates to the technical documentation should be done in a transparent manner. Both the changes and the dates of when the changes were made should be recorded. On the basis of the Declaration of Conformity and the corresponding technical documentation, the manufacturer should be able to demonstrate that the Declaration of Conformity was lawfully issued before 26 May 2020 and that, subsequently, there are no significant changes in the design or intended purpose in the meaning of Article 120(3) MDR,” the guidance says.
The MDCG recently released guidance on what a “significant change” means.
In addition to these two guidances, the MDCG also offered its third update to a guidance on BASIC UDI-DI and changes to UDI-DI, as well as the second update on the implant card required by MDR.
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
MDCG 2019-8 v2 - Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI