Medical Device Vigilance and Guidance 2.12.1 rev 5 Explained

The C arm on an X-ray vascular system used during a patient examination exhibited uncontrolled motion. The patient was hit by the image intensifier and her nose broke. The system was installed, maintained and used according to the manufacturer's instructions. The manufacturer becomes aware of the situation. Should the manufacturer report the medical device incident?

We all acknowledge the importance of medical device vigilance and the scenario described above illustrates the challenges of medical device incident reporting. While one can wax philosophical about interpreting the Annexes in the European Medical Device Directive MDD 93/42/EEC, and especially Article 10, Information on Incidents Occurring Following Placing of Devices on the Market, you really should focus your attention on the guidance documents (known as MEDDEVs) that detail the consensus opinion of the Medical Device Expert Group (MDEG). The MDEG is comprised of delegates from member state Competent Authorities, EUCOMED, EDMA, CEN, CENELEC, NB-MED, EAAR and others.

A MEDDEV is penultimate to legislation and should be considered as important as law, even though they are not legally binding. One pivotal document is MEDDEV 2.12.1, titled Guidelines on a Medical Device Vigilance System. According to MEDDEV 2.12.1 Rev. 5, the guidance suggests that the aforementioned scenario should be reported.

Medical Device Vigilance: European MEDDEV 2.12.1 Rev. 5

The new guidance boasts many additional pages, 21 definitions, the introduction of new terms and new template forms. In this document, reporting requirements are clarified and more stringent timelines are enacted. New definitions of existing concepts, Field Safety Corrective Action (FSCA), Field Safety Notice, use error and abnormal use are introduced and will be discussed further later in this column. The European Database EUDAMED also is described. In addition, Rev. 5 provides definitions for terms such as authorized representative (AR) and drug-device combination while contextual definitions are provided for words such as "immediately" and "unanticipated."

This medical device vigilance guidance incorporates several report form templates, some of which resemble forms from the German Institute of Medical Documentation and Information (DIMDI). The initial and final incident reports are consolidated into one form (Annex 3); a new form is included for a FSCA report (Annex 4); and the National Competent Authority Report Form is revised (Annex 6). Examples of medical device incidents that the manufacturer should report, as well as examples of FSCAs (Annex 1) and extracts of the Medical Devices Directive regarding vigilance (Annex 2), are still included.

One difference is that the flowchart illustrations from Rev. 4 have been deleted. In addition, the role and importance of the AR is acknowledged within the description of the manufacturer's role, and medical device incident reports now include this information in a separate field.

Medical Device Incident, Event, or Both?

The latest guidance requires the manufacturer to understand the difference between a medical device incident and event. A "near incident" now is considered an obsolete term, as this appears to be consolidated into the concept of incidents. All incidents are events, but not all events are incidents; events may be complaints or something else. Typically, incidents meet three reporting criteria: (1) An event has occurred; (2) The manufacturer's medical device is suspected to be a contributory cause of the incident; and (3) The event led, or might have led, to the death or serious deterioration in the patient's health or in the user or another person.

One additional event now described is that of the unanticipated adverse reaction or unanticipated side effect. Medical device incidents must be reported on the template report form Manufacturer's Incident Report (Annex 3). Each initial report must result in a final report unless the initial report simultaneously is filed as the final report. Reports should not be "unduly delayed because of incomplete information" and should adhere to the timescales provided. Also, as in the previous version, Rev. 5 includes text that the act of reporting a medical device incident is "not to be construed as admission of liability for the Incident or its consequences."

FSCA - Field Safety Corrective Action

A FSCA is synonymous with a systematic recall or withdrawal of the device from the market and is an action taken by a manufacturer to reduce the risk of death or serious deterioration of a patient's health associated with use of a medical device on the market. By promulgating the moniker FSCA, Rev. 5 attempts to harmonize the concept of recall in the European medical device industry.

There is no surprise here, but the FSCA needs to be reported in the Field Safety Notice template form provided in Annex 4, Report Form: Field Safety Corrective Action. The Field Safety Notice is provided to the competent authorities in all affected countries and to the national competent authority responsible for the manufacturer or AR, along with relevant documentation: related parts of risk analysis, background, description, justification, advice to distributor and user, and affected devices (serial, lot, batch number ranges).

The recommendation to report to the competent authority where the manufacturer or AR has its registered place of business is a departure from Rev. 4, which suggested (for medical devices subject to notified body review) the competent authority in the member state where the notified body is situated. It also is advisable that a draft Field Safety Notice be submitted 48 hours before it is disseminated for comment by a relevant competent authority, defined as where the manufacturer or AR has registered its place of business, where most of the affected devices are on the market, or any other appropriate national competent authority.

Reporting Timescales, Additional Definitions

The previous guidance, Rev. 4, indicated that medical device incidents had to be reported within 10 days and near incidents within 30 days. This often conflicted with the member states' transposed MDD 93/42/EEC (national laws) that provided timescales ranging from two to 30 days. Rev. 5 emphasizes the term immediately, which is defined as "without any delay that could not be justified." The manufacturer still can conduct research, but it had better have a reasonable explanation for doing so. Operational timescales in Rev. 5 are delineated:

  • Serious public health concern: immediately, no later than two calendar days after recognition by the manufacturer
  • Death or unanticipated serious deterioration in state of health: immediately, not later than 10 elapsed calendar days following awareness of the event
  • Others: immediately (not later than 30 elapsed calendar days following awareness of the event), or unanticipated (describes a condition leading to a serious deterioration in the state of health that was not considered in a medical device risk analysis)

Medical Device Vigilance in Closing

Vigilance is a challenging and complicated topic. Fortunately, we are guided by guidance; and, MEDDEV 2.12.1, Guidelines on a Medical Devices Vigilance System Rev. 5. Review this guidance to gain a better understanding of the consensus interpretation of medical device vigilance. In addition, you should assess your company's post-market surveillance procedures - of which vigilance is a component - to ensure that changes don't need to be made.

Emergo Group's is available to help you with medical device vigilance and risk management consulting services.

May 2007