MDCG 2023-3 Rev. 1 is newly available: HERE

Overview

MDCG 2023-3 was updated to include the IVDR within the scope of the guidance, as well as other general clarifications.

Some of the changes include:

Updated Flowchart

New Questions

MDCG 2023-3 Rev. 1
(8) What is considered ‘any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device’ as outlined in Article 2(67) IVDR? How is it reported within the IVDR vigilance system?   This should be understood to include any harm to a person’s health, which is not physically and directly caused by an IVD but is a consequence of a medical decision19, action taken or not taken, based on incorrect information or results obtained with the IVD.   In the majority of cases, IVDs will, due to their use on specimens, rather than directly on the human body, not lead to direct harm of a person’s health. These devices are more likely to lead to indirect patient harm, which is caused by a medical decision, action taken or lack thereof based on incorrect information or result(s) provided by the IVD.   An example of indirect harm linked to these devices is an IVD that provides results with insufficient accuracy, which results in an incorrect medical decision by the healthcare professional responsible for patient management. This incorrect decision leads to an inappropriate medical treatment of the patient, which leads to a serious deterioration in this person’s health. Any harm that is a consequence of a medical decision, action taken or not taken based on incorrect information or result(s) provided by an IVD, qualifies as an incident under Article 2(67) IVDR. Such incidents, which do not meet the criteria of a serious incident, must be reported in accordance with the requirements for trend reporting under Article 83 IVDR.   19 For some IVDs (e.g., self-testing devices), the medical decision is made by the user of the device, who is also the patient.
(9) What is an ‘expected erroneous result’ and how is it reported within the IVDR vigilance system?   An ‘erroneous result’ should be understood to include any incorrect (i.e. inadequate, inaccurate or imprecise) result or information provided by an IVD.   Expected erroneous results are established in comparison to the stated performance of the device as referred to in points (a) and (b) of Section 9.1 of Annex I of the IVDR and must be clearly documented and quantified in the product information and the technical documentation.   They should also be acceptable when weighed against the evaluated benefits to the patients and/or user arising from the achieved performance of the device during normal conditions of use (Section 8 of Annex I IVDR).20   Expected erroneous results should be reported in accordance with the requirements for trend reporting pursuant to Article 83 IVDR.   Erroneous results that are not documented and quantified in the product information and the technical documentation and hence fall outside the declared performance of the IVD, are to be handled like incidents. If such incidents qualify as serious incidents within the meaning of Article 2(68) IVDR, they should be reported in accordance with Article 82(1) IVDR as individual serious incident reports (i.e. as individual Manufacturer Incident Reports (MIRs)).   If the manufacturer cannot demonstrate that a potentially serious incident is an expected erroneous result within the deadlines set out in Article 82(3) – (5) IVDR, it should be considered a serious incident, and an MIR should be submitted within the defined timelines.   20 In this context, reference to ‘patient’ should be understood as the individual patient i.e., acceptable in terms of the individual patient benefit.
(11) Is it required to report serious incidents with CE- marked devices used in a clinical investigation or performance study?   Yes. CE-marked devices used in clinical investigations or performance studies are subject to the vigilance reporting requirements. Serious incidents related to such devices must be reported by the manufacturer in accordance with Article 87(1) MDR/Article 82(1) IVDR.24   The vigilance reporting provisions apply in the following cases: Serious incidents with any CE-marked device used within the intended purpose covered by the CE-marking, in a clinical investigation or performance study. Serious incidents with any CE-marked device used within the intended purpose covered by the CE-marking, in a post-market clinical follow-up (PMCF) investigation or post-market performance follow-up (PMPF) study.   24 Please note that, while vigilance reporting obligations for these devices lie with the manufacturer, the sponsor may also have an obligation to report serious adverse events in the context of clinical investigations or performance studies involving CE-marked devices. For guidance on the specific requirements on safety reporting in clinical investigations or performance studies, please refer to MDCG 2020-10/1 Rev 1 and MDCG 2024-4.
(19) Should manufacturers inform competent authorities of preventive or corrective actions in accordance with 83(4) MDR and 78(4) IVDR?   If a manufacturer identifies a need for a safety-related preventive or corrective action linked to a serious incident or a field safety corrective action (as referred to in Article 83(4) MDR/78(4) IVDR, second sentence), it must report this information to the competent authorities.   This information must be provided using the relevant vigilance report(s), i.e., the MIR or field safety corrective action form. In these reports, the manufacturer should provide a relevant description of the safety-related preventive or corrective action and the associated reference or case number. Preventive or corrective actions which are covered by Article 83(4) MDR/Article 78 (4) IVDR, first sentence, can be made available to the competent authorities either through the periodic safety update report (PSUR) or post-market surveillance report. Further relevant information can be found in Chapter 2.1.2 of the PSUR guidance, MDCG 2022-2133.   33 Please note that MDCG 2022-21 ‘Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745’ will be revised to include IVDR aspects. Please refer to the updated version when available at the following link: Guidance documents.

New Examples (Both MDR & IVDR)

MDCG 2023-3 (original)	MDCG 2023-3 (Rev.1)
How can incidents indirectly lead to a serious deterioration of health?   Examples of indirect harm may include: – a misdiagnosis, – a delayed diagnosis, – delayed treatment, – inappropriate treatment, – absence of treatment, – transfusion of inappropriate materials.	How can incidents involving a device indirectly lead to a serious deterioration in a person’s state of health?   Potential sources of indirect harm linked to a medical device or IVD may include (non-exhaustive list): – a misdiagnosis, – a delayed diagnosis, – delayed treatment, – inappropriate treatment, – absence of treatment, – transfusion of inappropriate materials.   An example of indirect harm is a device that provides imprecise readings, which results in an incorrect medical decision and, consequently, an incorrect medical treatment. For instance, a blood pressure monitoring device that fails to provide accurate measurements. Based on these incorrect measurements, the user of the medical device administers an incorrect dosage of medication, which leads to a serious deterioration in this person’s health and requires further medical treatment. Indirect harm, due to an incident that meets or has the potential to meet the outcomes of a serious incident, must be reported in accordance with Article 87(1) – (5) MDR/Article 82 (1) – (5) IVDR.
What is a ‘field safety corrective action’?   A FSCA may include: – the return of a device to the supplier or a recall, – a device exchange, – a device modification, – retrofit by purchaser of manufacturer’s modification or design change, – a device destruction, – advice given by manufacturer regarding the use of the device, such as additional information on maintenance, cleaning instructions, and training and/or the follow-up of patients, users or others, – recommended inspections/examination by device user (e.g. regular professional checks of proper functioning in a testing setting), – changes of software/firmware in the device, including device update (e.g. version rollback).	What is a ‘field safety corrective action’?   Examples of FSCAs are provided below (non-exhaustive list): – The return of a device to the manufacturer/supplier or a recall, e.g. due to incorrect labelling of reaction tubes. – A device exchange. – A device modification. – Retrofit by purchaser of manufacturer’s modification or design change. – A device destruction. – Advice given by manufacturer regarding the use of the device, such as additional information on maintenance, increased frequency of calibration, cleaning instructions, and training. – Recommended inspections/examination by device user (e.g. regular professional checks of proper functioning in a testing setting). – Changes of software/firmware in the device that are related to a safety issue (e.g. version update or rollback to an earlier version). – Correction of information provided on the labelling, such as corrections to the originally validated and stated shelf life of the device. – Changes to the packaging design of the device that will correct safety-related issues. – Instructions provided by the manufacturer concerning modifications to the clinical management of patients /samples, such as a recall of patients or patient samples for retesting, or reviews of previous test results.