Reporting of serious incidents

This webpage will only cover the specific requirements on the reporting of serious incidents.

Which devices and products are subject to the requirements on reporting?

The following device categories are subject to the requirements on the reporting of serious incidents:

• All CE-marked medical devices, in vitro diagnostic medical devices, and active implantable medical devices (AIMD) – including accessories, systems and procedure packs.
• Custom-made medical devices
• Nationella medicinska informationssystem (NMI) – certain non-medical device software products covered by national legislation

Serious adverse effects (SAE) with the following device categoris shall be reported within the framework of the clinical investigation or the performance study.

• Investigational devices - medical devices without CE-mark manufactured with the purpose of performing a clinical investigation.
• In vitro diagnostic medical devices without CE-mark manufactured with the purpose to perfom a performance study

Requirements on reporting

As a manufacturer, you are responsible to monitor, investigate and submit reports on serious incidents that took place in Sweden to Läkemedelsverket (the Swedish Medical Products Agency, Swedish MPA). If the serious incident took place in another member state in the EU, the report shall be submitted to the competent authority to the member state in question. In the text below, only Läkemedelsverket (Swedish MPA) will be mentioned, but the principles and requirements apply equally to any concerned competent authority in other member states. Contact points for all competent authorities are available on the website of the European Commission.

The definition of the incident that shall be reported is somewhat different between MDR/IVDR and the directive-based legislation.

Please note that the manufacturer shall err on the side of caution. If you are uncertain if an incident that you have been made aware of is reportable or not, you shall submit a report within the required timeframe.

Devices according to the full requirements of MDR/IVDR

You shall submit reports on serious incidents to Läkemedelsverket (Swedish MPA).

Definition of serious incident: 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 requirements on reporting of incidents are laid down on arcticle 87 in MDR and article 82 in IVDR respectively. National provisions on the process of reporting until Eudamed is fully functional are laid down in HSLF-FS 2021:32.

“Legacy devices” – devices subject to the transitional provisions

Manufacturers that have placed legacy devices on the marker after 26 May 2021 (MDR) or 26 May 2022 (IVDR) according to the transitional provisions are subject to the requirements on reporting in MDR and IVDR respectively.

“Old devices” – devices placed on the market prior to MDR/IVDR

Devices placed on the market according the directive-based legislation prior to the date of application of MDR/IVDR – ”old devices” – are subject to the requirements on reporting in the directive-based legislation.

Formally, the legal requirements on incident reporting and the legal definition of the reportable incident are in Swedish national legislation only available in Swedish. However, the national provisions have the same meaning as the definition (see paragraph 4.10) and the procedures described in MEDDEV 2.12/1, rev 8.

Definition of reportable incidents in the Swedish implementation of the directives; Tillverkaren ska omedelbart underrätta Läkemedelsverket om varje felfunktion eller försämring av en produkts egenskaper eller prestanda, och alla felaktigheter i en produkts märkning eller bruksanvisning, som kan leda till eller har lett till en patients eller användares död eller en allvarlig försämring av hälsotillståndet för någon av dessa personer.

Custom-made devices

Incidents involving custom-made devices shall be reported in the same manner as CE-marked medical devices according to MDR (custom-made devices that left the manufacturer from 26 May 2021) or as “old devices” (custom-made devices that left the manufacturer prior to 26 May 2021) respectively.

Nationella medicinska informationssystem (NMI)

Incidents involving Nationella medicinska informationssystem (NMI) placed on the market according to the requirements in the new legislation (HSLF-FS 2022:42) shall be reported in the same manner as devices according to MDR.

Incidents involving Nationella medicinska informationssystem (NMI) placed on the market according to the requirements in the old legislation (LVFS 2014:7) shall formally be reported in the same manner as ”old devices” (see also bilaga 2 to the guidance document on NMI, only in Swedish). However, the transitional provisions for NMI:s laid down in the new legislation (HSLF-FS 2022:42) states that the reporting of incidents preferably should be performed according to the requirements in MDR.

Who shall submit reports to Läkemedelsverket (Swedish MPA)?

Several types of economic operators are subject to the requirements on incident and safety-related reporting in MDR/IVDR. The requirements are adapted to the responsibilities of each economic operator.

Even though some of the requirements below does not apply to ”old devices”, Läkemedelsverket (Swedish MPA) encourages all operators to apply the principles in the interest of patient/user safety.

• Manufacturers shall report serious incidents, field safety corrective actions (FSCA), trend reports and period summary reports (PSR) to Läkemedelsverket (Swedish MPA).
• Importers and distributors shall inform Läkemedelsverket of all instances where a device presents a serious risk or is a falsified device. The manufacturer or the authorised representative shall also be informed. Importers and distributors shall also report all suspected incidents and complaints that they are made aware of to the manufacturer or the authorised representative.

What shall be reported to Läkemedelsverket (Swedish MPA) by the manufacturer?

Any incidents, as described above, that have taken place in Sweden, shall be reported to Läkemedelsverket (Swedish MPA). In analogue, incidents that have taken place in other EU countries shall be reported to the concerned authorities.

Examples of incidents:

• a blood glucose meter that provides erroneous results which leads to incorrect, or lack of, treatment with insulin and other medicinal products.
• an infusion that suddenly and unexpectedly stops working without sounding an alarm which leads to incorrect, or lack of, treatment with the prescribes products
• a walking aid that drops a wheel during usage and causes (or could have caused) the patient/user to fall over
• a confounding of patient data, for example lab resultas, caused by software errors in the system for patient records which leads to incorrect, or lack of, treatment.

These example may lead to temporary or permanent (serious) deterioration of a patient’s health.

Exemptions from the requirements on reporting: Expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting. Läkemedelsverket (Swedish MPA) encourages manufacturers to err on the side of caution also in such cases.

When shall the reports be submitted?

Manufacturers shall report any serious incident as referred to in immediately after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible.

To ensure a rapid reporting process and awareness, the manufacture should submit an initial report with the available data at the time and amend it as soon as further information comes to light. When the manufacturer has completed the investigation of the incident and reached a conclusion, it shall be reported as a final report.

The regulatory time frames are defined by the possible outcome of the incident(s) and is as follows.

• In the event of a serious public health threat the report shall be provided immediately, and not later than two (2) days after the manufacturer becomes aware of that threat
• In the event of death or an unanticipated serious deterioration in a person's state of health the report shall be provided immediately but not later than ten (10) days after the date on which the manufacturer becomes aware of the serious incident
• Any serious incident shall be reported immediately after the manufacturer has established the causal relationship between that incident and its device(s) or that such causal relationship is reasonably possible and not later than 15 days after the manufacturer become aware of the incident with a device according to MDR/IVDR or a “legacy device”. Such incidents with an “old device” shall be reported no later than 30 days after the manufacturer becomes aware of the incident.

The definitions of serious public health threat and serious incident are found in MDR/IVDR. The regulatory time frames for reporting are laid down in MDR/IVDR for devices according to MDR/IVDR and ”legacy devices”. The time frames for ”old devices” are established in the guidance document MEDDEV 2.12/1, rev 8.

Submitting reports with the e‍-‍service

Until Eudamed is fully functional, reports on the any incidents, as described above, with medical devices that has taken place in Sweden shall be submitted to Läkemedelsverket (Swedish MPA). Any incidents, as described above, with nationella medicinska informationssystem (NMI) that has taken place in Sweden shall be submitted to Läkemedelsverket (Swedish MPA).

The manufcaturers shall submit incident reports to Läkemedelsverket (Swedish MPA) with an e-service. In the e-service, you upload the completed form that is appropriate for the product type (medical device or NMI), see below for further informatione. Before you enter the e-service, please make sure that you have completed the appropriate form and saved it in the required formats. For medical devices, both PDF- and XML-formats shall be uploaded. For NMI, you may use either PDF- or Word-format for the upload.

Form for medical devices

Until Eudamed is fully functional, reports on the any incidents, as described above, with medical devices that has taken place in Sweden shall be submitted to Läkemedelsverket (Swedish MPA).

The reports are submitted by using the common form for ”Manufacturer Incident Report” (MIR). The form and accompanying help texts are published on the website of the European Commission.

Downloading and completing of the form

Unfortunately, the MIR form, cannot be used in the built-in PDF-reader in popular web browsers like Edge and Chrome. In order to use the form, you need to download and save it to your computer and use an external PDF viewer such as Adobe Reader (freely downloadable from the web).

How to download and save the form:

• Follow the link to the MIR form download page at the European Commission
• Right click on the document link
• Choose “Save link as”
• Choose the folder on your computer where the form shall be saved
• Save
• Done

MIR – help texts

The design and content of the MIR form is the same as will be available in Eudamed. Among other thing, certains aspects of the investigation shall be detailed with codes. The applicable codes for Adverse Event Reporting (AER) are described by the International Medical Device Regulators Forum (IMDRF) in the guidance document IMDRF/AE WG/N43FINAL, including annexes.

Save PDF- and XML- from the MIR form

When the MIR form is completed with the mandatory information, and any other information you can offer, you need to save it in PDF- and XML-format. Please note that you need both formats before closing the file as some functionality in the form is lost once it has been saved.

Saving in PDF-format

• Use the button ”Save as PDF” in one of the boxes close to the bottom of the form.

• Choose the folder on your computer where the PDF file shall be saved
• Save
• Done

Saving in XML-format

• Use the button ”Submit XML by Email” in one of the boxes close to the bottom of the form.

• A draft e-mail message is opened in your e-mail client where the XML file is attached.
• Enter an e-mail address (e.g. your own) as the recipient and send the message.
• Use you e-mail client to save the attached XML file to the desired folder on your computer

By completing these steps, you have prepared the necessary documents to submit an incident report in the e-service.

Reporting form for nationella medicinska informationssystem (NMI)

Reports on incidents with nationella medicinska informationssystem (NMI) shall use the specific form that is submitted in the e-service. The form is only available in Swedish, please contact Läkemedelsverket (Swedish MPA) if you need help to complete the form.

Guidance document