Medical devices illustration

Manufacturer's incident reporting procedure

Manufacturer’s incident reporting procedure

The incident reporting procedure for medical devices differs depending on the regulatory framework under which the device is placed on the market. Devices that have not been permitted to be placed on the market since 26 May 2021 are so-called “old devices” for which the incident reporting procedure set out in Directive 93/42/EEC and Act 629/2010 is to be complied with. The incident reporting procedure set out in the Regulation is applied to the legacy devices placed on the market pursuant to Article 120(3) and to devices in accordance with the Regulation. 

The MIR form published by the Commission shall be used for all manufacturer’s incident reports, and the requirement to use the IMDRF codes also applies to all devices irrespective of the regulatory basis. It should also be borne in mind that the definition of an incident report, as well as the reporting deadlines, differ between Act 629/2010 and Regulation 2017/745.

Devices in accordance with the Directive

For devices in accordance with the Directive, the incident reporting procedure previously in use shall be followed, i.e., all adverse events that meet the criteria shall be reported on the MIR form. If the adverse event that comes to the manufacturer’s attention does not meet the criteria for an incident report, the event shall be classified according to section 1.2.d of the form as “Final (Non-reportable incident)” and the rationale shall be filled out in section 4.2.b of the form. 

Incident is defined as

situations that have or might have led to a risk to the health of the patient, user, or other person and that result from the

  1. characteristics
  2. malfunction or deterioration in performance
  3. insufficient labelling
  4. insufficient or incorrect instructions for use of a medical device.

Reporting deadlines

  • Death or unexpected serious deterioration of health 10 days
  • Other events no later than 30 days of the date when the manufacturer became aware of the case.

GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM MEDDEV 2.12-1 rev 8

Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8

Adverse incident reporting procedure in accordance with the Regulation

The requirements of the Regulation for the incident reporting procedure differ from those set out in the Directive. Earlier, basically all incidents were reported as isolated incidents, but in future, serious incidents pertaining to compliant devices and legacy devices will be reported as individual reports, and incidents and expected side effects as trend reports. Separate forms shall be used for the reporting. The serious incident form was published in early 2020, and the trend reporting form will be published during 2021.

The Commission will publish a Questions and Answers document to guide the implementation of incident reporting in accordance with the Regulation. The matters pertaining to IVD devices will be added to the Questions and Answers document as soon as the IVD Regulation becomes applicable. A more comprehensive guide will be published at a later date.