Reporting incidents involving medical devices on time

The Dutch Health and Youth Care Inspectorate (IGJ) ensures compliance with the law by checking whether manufacturers of medical devices and in vitro diagnostic medical devices (IVDs) actively investigate users’ experiences with their products. By law, manufacturers are required to promptly report to the Inspectorate any incidents involving their products. As of 2023, the Inspectorate is placing greater emphasis on this issue. This page informs manufacturers about these requirements.

8,000 reports annually, 10% submitted too late

The new European MDR and IVDR regulations specify the deadlines for manufacturers when it comes to reporting incidents concerning medical devices and IVDs to the Inspectorate. Most manufacturers report such incidents on time and this provides us with timely insight into an incident. The Inspectorate can then intervene, if necessary.

We receive approximately 8,000 reports annually. The Inspectorate examines all reported incidents thoroughly to determine if the products contributed to them. We assess whether the incident indicates an unknown risk associated with the product and if the manufacturer is putting sufficient effort into mitigating the risk. Of all the reports received, 10% are submitted after the deadline. Since late reporting can result in risks to patients and the safety of the medical device and its use, we are focusing particular attention on this issue. It is, however, always preferable to report incidents later than not at all.

What can you expect?

The Inspectorate will send a warning in the first instance and will only escalate enforcement actions when necessary.

Summer 2023
1. Complying with the duty to report
  
  We understand that improving reporting practices within organisations takes time. To assist in this, we provide information on this website and by post. The Inspectorate offers information to manufacturers within and outside Europe through their umbrella organisations and/or authorised representatives. The Inspectorate will also speak to umbrella organisations about late reporting and associated enforcement efforts. Sufficient time will be given to implement any necessary adjustments. In the autumn of 2023, we will start writing to manufacturers who are late with reporting
As of autumn 2023
1. Checking for late reports
  
  We will be paying particular attention to how much time has passed between the date on which you became aware of an incident and the date when the incident was reported to the Inspectorate. If your report is late, this does not necessarily mean that you deliberately violated the law. For example, you might have made a typing error when entering the dates or that you reported something that did not have to be reported bylaw. We will establish the facts and do so as efficiently as possible.
  
  If you have been late in reporting incidents multiple times within a three-month period, you will receive a second letter from us. It will point out that you were late in reporting incidents, may consequently have broken the law and must report incidents on time in the future.
From the end of 2023 onwards
1. Measures and/or an investigation following late reports
  
  After a few months, we will assess the impact of these two letters and determine whether the number of cases of late reporting has dropped and if fewer manufacturers are late in reporting incidents. We assume that this will be the case but will also look at whether manufacturers are continuing to report incidents too late. If so, we will carry out an additional investigation and, if necessary, will implement certain measures, such as imposing fines.

Why is reporting on time important?

Reporting incidents involving medical devices on time is vital for the following reasons:

It is important to guarantee the quality of care and monitor risks at all times. If serious incidents occur involving medical devices, the Inspectorate needs to know about them as soon as possible. This enables us to monitor how manufacturers and healthcare providers are responding and determine the facts. The aim is for manufacturers to learn from incidents and improve their products if necessary. This should help prevent similar incidents in the future.
If manufacturers are late in reporting incidents, it may be a sign that there are other issues involved. The manufacturer might not, for example, be sufficiently familiar with the law. Establishing which manufacturers are regularly reporting incidents late will allow the Inspectorate to devote appropriate time and attention to this matter.
It is not fair if some manufacturers invest time and energy in reporting incidents on time while others do not and are not held accountable for this.
Finally, reporting incidents late is a breach of the law. It is the duty of the regulatory body to hold manufacturers to account for such non-compliance.

I want to report an incident

Your point of contact for questions

Do you have any questions regarding the regulation on the timely reporting of incidents involving medical devices? Our contact details can be found on the contact page (in Dutch) under the heading 'Contact met ons opnemen als (zorg)professional', and then under 'Algemeen'. Please state 'Response to Reporting incidents involving medical devices on time’ in your communication with us.

Reporting incidents involving medical devices on time

8,000 reports annually, 10% submitted too late

What can you expect?

Summer 2023

As of autumn 2023

From the end of 2023 onwards

Why is reporting on time important?

Your point of contact for questions

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