Reporting serious incidents and corrective actions (FSCA)

European MDR and IVDR regulation: central registration

The European legislation for medical devices (MDR) came into effect on 26 May 2021 and the regulations for in vitro diagnostic devices (IVDR) came into effect on 26 May 2022.

Both regulations contain new rules for the reporting of serious incidents relating to medical devices and IVDs. A major change for both economic operators and EU Member States is the obligation for central registration of vigilance information within the European database EUDAMED (MDR Article 8792, IVDR Article 87).

EUDAMED transition period

The EUDAMED is currently under development. EUDAMED is expected to become fully functional by mid-2024. Until then, reporting obligations are fulfilled by national provisions i.e. serious incidents and Field Safety Corrective Actions (FSCA) relating to medical devices or IVDs are reported to the Inspectorate. Please find more information on this issue in the European Guidance on administrative practices (PDF file, 799 kB).  

Reporting incidents

If your medical device or IVD was involved in a serious incident, you must report this to the Inspectorate. In cooperation with stakeholders from the industry the European member states have developed a form which can be used to report incidents with medical devices or IVD's.
You should use this MIR form to report incidents to us until EUDAMED is fully functional The following rules then apply:

• Fill in the incident form and send it to us by clicking the 'Submit XML by Email' button and attaching the entire form as a PDF file.
• You can also add other attachments which are relevant to this incident.
• You should send your email to meldpunt@igj.nl and in the subject line you should state 'Your reference number: [your reference number] | Our reference number:[our reference number]'

MIR form and clarification (In English):

• Form Manufacturer incident report 2020 (MIR)
• Clarification Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form

Reporting a corrective action (Field Safety Corrective Action, FSCA)

If you rectify a defect or fault on one of your products, you must report this to the Inspectorate. Examples include:

• general recalls
• changes to the design
• changes to the instructions for use
• changes to your product's packaging

For automatisation pusposes we ask you to supply the information to the Inspectorate in the following format. Please fill in the digital form and save it. Then add the form as an attachment to an e-mail message. You can also add other attachments which are important for the report. Send the email to: meldpunt@igj.nl.

Forms and clarification (In English):

• Corrective action form Field Safety Corrective Action (FSCA)
• Safety notice form Field Safety Notice (FSN)
• Clarification Questions and Answers to fill in the Field Safety Notice

When should I report?

If you are aware of a serious incident involving your product, or communicate a corrective action to your clients, you must report this as quickly as possible to the Inspectorate. The set deadlines in accordance with the MDR are:

• No later than within 15 calendar days after you have been informed of a serious incident.
• No later than within 2 calendar days after you have been informed of a serious incident which implies a serious threat to public health.
• No later than within 10 calendar days after you have been informed of a serious incident which has led to a death, or a serious deterioration in someone's state of health.
• You must report a serious incident before the corrective action to eliminate the risk is taken, except in an emergency, in which case you must immediately carry out a field safety corrective action.

What happens to my report?

The Inspectorate will confirm receipt of your report in writing. The Inspectorate will assess:

• the extent to which the incident constitutes a risk to patient safety.
• whether the corrective action sufficiently reduces the chance of the incident reoccurring.
• whether further research is required on the basis of your report.

The Inspectorate will place your Field Safety Notice (FSN), which relates to your corrective action, on its website: Warnings by manufacturers of medical devices (in Dutch).

In addition, personal data as described in the General Data Protection Regulation (GDPR) will be made illegible. The Inspectorate believes it is important for FSNs to be accessible to professionals and citizens . This gives them the possibility to consult safety information about specific medical devices or IVDs.

The importance of a good report

On the basis of the information you supply, the Inspectorate will assess the risk and start an investigation as deemed necessary. It is therefore important that you describe the incident as comprehensively as possible and in understandable language. You should demonstrate that you have obtained the information from the care provider or other parties involved and defined elements such as:

• The root cause and consequence of the incident. Assess the basic cause against the risk analysis of your product and provide arguments as to whether it falls within the applicable limiting values.
• Provide evidence of which preventive and/or corrective actions you are taking to prevent comparable incidents.

Medical devices for in vitro diagnostics

The legislation for in vitro diagnostic medical devices (IVDR) will be coming into effect on 26 May 2022. Until then the current IVDD 98_79_EC will continue to apply and you can report incidents and corrective actions under this directive to us.

You can find more information on reporting incidents involving in vitro diagnostic medical devices in section 2.12 of the European guidelines:
Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System - MEDDEV 2.12/1 rev.8

More information about EUDAMED

More information on the future developments of EUDAMED, registration and the issuing of the Single Registration Number (SRN) can be found via:

• Registration of market participants in EUDAMED (in Dutch)
• Central government: Which details do manufacturers, authorised representatives and importers have to register in EUDAMED? (in Dutch)