And Then There Were Eight: the 2013 Revision of EU Vigilance Guidelines for Medical Devices

March 14, 2013 – 1:51 am

From the Consultant’s Corner Newsletter, March/April 2013

Revision 8 of MEDDEV 2.12-1, the new European medical device vigilance guidelines, will replace the current version in July 2013. Are you ready? The time is right to ask the question, since you may need to update your vigilance procedure.

The main addition in this new guidance concerns in vitro fertilisation (IVF) and assisted reproduction technology (ART) products, which are now explicitly included within the scope of the vigilance system. Additional notes are related to the “indirect harm” concept.

More clarity is provided on the reporting of incidents and field safety corrective actions (FSCA) involving devices that are not intended to act directly on a person. Where the manufacturer of an IVD, IVF/ART or diagnostic medical device, such as software, identifies that an event has or could result in indirect harm or has or might have led to death or serious deterioration in a person’s health, a Manufacturer Incident Report should be submitted.

Indirect harm may be caused by imprecise results, inadequate quality controls, inadequate calibration, reagent failures (contamination, transcription errors and reduced stability, for example), false positive or false negative results, and IVD software anomalies, such as an incorrect correlation between patient sample and the obtained result.

An Incident Report or FSCA shall be notified to the relevant Competent Authority when the aforementioned failures could lead to a patient management decision resulting in:

  • an imminent life-threatening situation to the individual being tested or to his or her offspring
  • death or severe disability to the individual or fetus being tested or to his or her offspring

The Field Safety Notice (FSN) may include modifications to the clinical management of patients, a recall of patients or patient samples for retesting or the review of previous results/samples.

Most medical device manufacturers are not affected by the new guidelines. The Incident and Field Safety Corrective Action (FSCA) report forms remain unchanged. However, do remember to replace the term revision 7 with revision 8.

We can deplore that no additional guidance is provided concerning the reportability of events and FSCAs to national Competent Authorities (NCAs). That would help manufacturers and allow a consistent application of the guidelines by all EU NCAs.

For example, upon reporting an incident of a patient who has been seriously injured due to a use error to German NCA BfArM, you will immediately receive a letter stating the following:

“As you assessed the incident to be reportable according to the German Ordinance, you affirm that an incident occurred that has led or could have led to the death or serious deterioration in the state of health of a patient ‘due to a malfunction of the involved medical device.’ Currently you declare in the report that a malfunction of the involved medical device is not related as a root cause of the incident.”

Following that, BfArM will request that you review your vigilance procedure for the assessment of incidents because Criteria A was not fulfilled (meaning the event was not reportable).

If you fail to report the same incident to French NCA ANSM, you are liable.

Regarding FSCA, the main criteria for reportability to the relevant CA is the Health Hazard Evaluation. The fact that the vigilance guidance includes examples of FSCAs that the manufacturer should report means that if the likelihood of a serious deterioration in the state of health is remote, the FSCA is not reportable.

To avoid any misunderstandings by your Notify Body or CA, we recommend that you consider a recall to be nonreportable (i.e., no health risk). It is preferable to replace FSCA by FCA (Field Corrective Action) and FSN by recall letter, because there is no link to the safety of the patient or user.

Revision 8 of the EU guidelines on a medical device vigilance system can be downloaded at the Europa website.

 —René Clément

 René Clément is co-chairman of MediMark Europe, which serves as an authorized representative for US manufacturers of medical devices and IVD products. For more information about the firm, visit the company’s listing on Qmed.


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