When and how to report a medical device product fault to EU regulators

by | Aug 22, 2023 | EU, IMed Consultancy, MDR

Article 120_Europe

Do I need to report a medical device product fault to EU regulators?

All products, including medical devices, are not immune to faults and failures. Unfortunately, an undetected manufacturing defect, an error in the use of the product, or other safety problems encountered during the product’s use by clinicians and patients, may occur endangering patients. In these instances, medical device regulations require these ‘serious incidents’ to be reported to the regulator in the country the problem happened in.

In this article, we will focus on serious incidents which have occurred in the European Union and are reported following the EU Medical Device Regulation (EU) 2017/745. The definition used in the EU for a serious incident is “any incident that directly or indirectly led, might have led or might lead to any of the following:

  • the death of a patient, user or other person
  • the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health
  • a serious public health threat

The reporting deadlines for the EU have been made very strict and require reporting to the relevant EU regulator between 2 and 15 days after the manufacturer first becomes aware of the incident. Awareness is considered to be the first time that a person within the manufacturer’s organisation is made aware of an incident. Field service, customer service, and sales personnel in contact directly with customers may be the first personnel aware of a serious incident, so internal procedures and training for handling complaints and customer feedback information are important for the timely evaluation and reporting of serious incidents.

The first step in determining if you need to report the serious incident to an EU regulator is to evaluate the reportability of the incident and confirm if all 3 of the following general attributes are met.

  1. An incident has occurred.
  • A medical device has malfunctioned, or not performed as expected – when used in accordance with its intended purpose, according to the manufacturer’s instructions for use.
  • A clinical procedure or other activity has taken place, and not gone to plan. For example, a surgery has been aborted during the procedure.
  1. The manufacturer’s medical device is suspected to have contributed to the incident.
  • There does not need to be a direct causal association, a reasonable probability that the device has contributed to the incident is enough to meet this attribute.
  1. The event led, or may have led to a death, or serious deterioration in the health of a person.
  • A serious negative health outcome could have occurred to a patient, healthcare professional, or other people interacting with the device or patient.
  • A serious deterioration could be a life-threatening situation, a permanent impairment a loss of a body part, or a temporary impairment such as bone fracture. The evaluation should also include indirect harm, including psychological effects – for example, if an IVD test incorrectly identifies a patient has a high-risk disease (false positive).

Evaluation should be performed by the manufacturer according to their documented procedures, and the results of the evaluation documented.  If the incident meets all the criteria outlined above, the incident must be reported to the EU regulator in the country where the incident occurred. The report may also need to be sent to the medical device’s EU Notified Body, the EU Authorised Representative, and other EU stakeholders.

The EU has developed a mandatory incident reporting form, detailing the structured information which must be submitted directly to the relevant EU regulator. In the future, reporting will be possible using a new EU-wide database, EUDAMED.

Due to the strict reporting deadlines, in many cases, an initial report will need to be submitted without the completion of a full investigation, with follow-up reports needed as the investigation progresses, and final reports when the investigation is completed.

Find out how IMed Consultancy can support you in evaluating your reporting needs and ensuring your reports satisfy requirements in the US by contacting hello@imedconsultancy.com

Tim Bubb

Tim Bubb

Technical Director

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