Paul-Ehrlich-Institut

Go to:

Information on the Use of Cookies

In order to operate and optimise our website, we would like to collect and analyse statistical information completely anonymously. Will you accept the temporary use of statistics cookies?

You can revoke your consent at any time in our privacy policy.

OK

Reporting Forms

Reporting of incidents, recalls, serious adverse events (SAEs), and trends.

Note: You may receive an error message when opening the forms in your browser or using a PDF plugin. The Paul-Ehrlich-Institut is working on solving this issue. We recommended saving the forms (right click to access the context menu and select "Save target as") and opening them locally.

Incidents

Reporting of serious incidents by manufacturers and authorised representatives pursuant to Article 82 of the EU Regulation on In Vitro Diagnostics (IVDR)

Date Title
18.11.2022 Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD)

Reporting of suspected serious incidents by users and operators as well as by patients or their relatives in accordance with Section 3 or Section 4 of the Medical Devices User Reporting and Notification Ordinance (Medizinprodukte-Anwendermelde- und Informationsverordnung, MPAMIV)

Date Title
20.06.2023 Incident report form for users and operators as well as for patients or their relatives in accordance with Section 3 or Section 4 of the MPAMIV

Recalls/Field Safety Corrective Action (FSCA)

Reporting of field safety corrective actions pursuant to Article 82 of the IVDR

Date Title
03.07.2015 FSCA report form for manufacturers, authorised representatives, importers, or distributors (German only)
03.07.2015 FSCA report form for manufacturers, authorised representatives, importers, or distributors

Serious Adverse Events (SAEs)

Reporting of serious adverse events (SAEs) in a performance study pursuant to Article 76 of the IVDR

Date Title
20.06.2023 Serious adverse event (SAE) report form for sponsors
09.10.2023 SAE report table for quarterly, cumulative reporting

Sponsors are obligated to report the following events:

  • Any serious adverse event where there is or appears to be a causal relationship with the medical device being tested, comparator, or procedures used in the study to be tested.
  • Any device deficiency that could have led to an SAE.
Country in which the SAE occurredDeadline for notifications to the PEIForm
GermanyimmediatelySAE Form

Individual submission of SAE reporting form for Germany (current version)
all other countries in which the clinical trial is being conductedimmediately

SAE Report Table v2.0*

*Please cumulatively document all SAEs from investigational sites outside of Germany that are subject to immediate and quarterly reporting on the same spreadsheet.

If a connection between the SAE and the medical device to be tested, a comparative product, the therapeutic or diagnostic measures applied in the clinical trial or the other conditions under which the clinical trial was conducted can be ruled out:

Country in which the SAE occurredDeadline for notifications to the PEIForm
GermanyquarterlySAE Report Table v2.0*
all other countries in which the clinical trial is being conductedquarterly

SAE Report Table v2.0*

*On this spreadsheet (in the same Excel file), please also document cumulatively all SAEs from German investigational sites, regardless of whether they are subject to an immediate or quarterly reporting obligation.
We would like to point out that all SAEs subject to the immediate reporting obligation from German investigational sites are also obliged to immediately submit an individual report using the corresponding form.

Trends

The reporting of trends by the manufacturers must be carried out in accordance with Article 83 of the IVDR. Any statistically significant increase in the frequency or severity of non-serious incidents shall be reported if:

  • the increase could have a significant impact on the benefit-risk analysis
  • it has led or may lead to unacceptable risks to the health or safety of patients, users or other persons
  • it has led or may lead to a significant increase in expected erroneous results compared to the declared performance of the device.

Trends can be reported informally via email.

Please send the completed form or report to biovigilance@pei.de.

Updated: 09.10.2023

top