In January 2013 new Revision 8 of MEDDEV 2.12-1 about vigilance system in Europe was posted on the European commission webpage.
The document itself can be found here.
We’ll highlight below the changes that occured in the new guidance.
As mentioned in the introduction of the document:
“Revision 8 of MEDDEV 2.12-1 explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual. The revised guidance will be applicable as of July 2013.”
The document is not giving a definition of what is an IVF/ART devices though.
IVF: in-vitro fertilization.
ART: assisted reproductive technologies
That said let’s go to the details of MEDDEV 2.12-1 Rev.8:
- The section related to devices not intended to act directly on individuals is now more specific since it mentions now explicitly : diagnostic devices, IVDs and IVF/ART, software. The reporting activities are now clearly mentioned for those devices (the same way as for other medical devices). Additionally there is an important addition: for IVDs and IVF/ART due to the nature of the product “It may be difficult to determine if a serious deterioration in the state of a patient’s health was or could be the consequence of an erroneous result obtained” from such products. In case of doubt a report should be submitted.
- The FSCA section (Field safety corrective action) mentions also clearly now that: “Such actions, whether associated with direct or indirect harm, should be reported“.
- In Note 2: An FSCA must be initiated if the manufacturer identifies a failure of a device to perform as per the information for use and if it might have led to death/serious deterioration of in the state of health
- In Note 3: more details about device modification. Permanent changes to the labeling or instruction for use (quality control procedures…), change to storage conditions for samples used with IVDs, advice issued to users relating to a change in the stated shelf life of an IVF/ART, Software upgrades following identification of a fault of the current version
- Indirect harm section of the MEDDEV 2.12-1 is of course modified to be in line with the rest and include considerations about IVD/ART. As an example the absence of treatment is the only addition to the list of indirect harms. Indirect harms may be caused by : imprecise results, inadequate quality controls, inadequate calibration, false positive or false negative results.
- Medical device definition is now including diagnosis, investigation/modification of the anatomy or physiological process, control of conception
- In criteria for incident reportingof MEDDEV 2.12-1, IVDs are considered. For high risks IVDs all false positive/negative test results shall be considered as events. For other IVDs, the same has to be considered if such results fall outside of the declared performance.
- Example were added in the Annexes. For reportable incidents: “A user discovers that an IVF culture medium is contaminated resulting in degeneration of the cells. This INCIDENT should be reported“. For reportable FSCA: “IVF/ART MANUFACTURER informs users of an error on the labeling of their device which indicates a shelf life longer than the validated shelf life for the product. The FSCA should be reported“
- The report forms given in the annex have been modified and there are significant modifications related to National Competent Authorities reports which do not concern manufacturers.
In conclusion IVDs and IVF/ART manufacturers will have to take a close look at their risk management process and vigilance procedures to consider necessary updates based on the above in order to comply with the MEDDEV 2.12-1. These modification is also reflected in the release of the Medical Device Regulation 2017/745 and the In Vitro Diagnostic Regulation 2017/746, considering also that IVF/ART are specifically added as per the classification rules.
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