Jul 17, 2019

The European Commission has published new guidance clarifying manufacturers’ obligations under the Medical Device Vigilance System established by the Medical Devices Directive (MDD).

The guidance augments issues covered by MEDDEV 2.12-1 rev. 8, including Manufacturer’s Incident Reports (MIR), and field safety actions and notices, and device-specific vigilance reporting recommendations.

Updated MIR incident reporting form

First, the guidance covers an updated version of the MIR form that will become mandatory for manufacturers certified under the MDD starting in January 2020.

The updated MIR includes coding and terminology based on International Medical Device Regulators Forum (IMDRF) recommendations; provides a definition of and new formatting requirements for similar reportable incidents; and paves the way for use of SRN and UDI data in MRIs, which will become mandatory under the Medical Devices Regulation (MDR).

Field safety-related definitions, distribution and content

The guidance also distinguishes between field safety corrective actions (FSCAs) and field safety notices (FSNs):

  • FSCAs are undertaken by manufacturers to reduce health risks posed by devices already on the European market.
  • FSNs are communications sent by manufacturers to consumers and users in relation to FSCAs.

Furthermore, the guidance states that manufacturers should initiate FSCAs in all markets in which devices in question are commercialized. “Robust and objective” rationales should be provided in cases where a manufacturer decides not to distribute a field safety notice in a particular market.

“It is not sufficient to include in the FSN distribution only countries where adverse incidents have occurred, as the principles of the EU Vigilance System are preventative,” states the guidance.

In addition, FSN content should be “uniform and consistent” for all European Economic Area member states, Switzerland and Turkey where such notices are to be distributed, according to the guidance. In addition, FSN content should neither downplay the level of risk stemming from an incident nor advertise products or services.

Device-specific vigilance

Guidance documents pertaining to vigilance reporting for specific types of devices (cardiac ablation products and coronary stents, so far) has now been compiled on the Commission’s main MDD guidance webpage.

Learn more about medical device vigilance reporting requirements in Europe:

  • EU medical device vigilance and incident reporting support
  • Whitepaper: EU medical device vigilance reporting requirements