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Clinical trials or performance evaluations

Information on submission of a request for authorisation of a clinical trial or a performance
evaluation to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in accordance with Section 22a of the German Act on Medical Devices

In accordance with Section 20 sub-section 1 of the German Act on Medical Devices ("Medizinproduktegesetz", MPG) as amended on 21 March 2010 (cf. Article 6 of the Law of 29 July 2009 (Bundesgesetzblatt [Federal Law Gazette] BGBl. I page 2326)), conducting clinical trials of medical devices and performance evaluations of In-vitro Diagnostic Devices (IVDD) requires authorisation by the competent federal higher authority ("Bundesoberbehörde"). ... further information

Information on submission of a request for waiving the authorisation of a clinical trial or a performance
evaluation to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in accordance with Section 20 sub-section 1 sentence 2 of the German Act on Medical Devices

In accordance with Section 20 sub-section 1 sentence 2 of the German Act on Medical Devices ("Medizinproduktegesetz", MPG) the competent federal higher authority can waive the authorisation in case of clinical trials of medical devices with a low safety risk. In accordance with Section 24 MPG, the same applies to performance evaluations of low-risk in vitro diagnostic devices. ...further information

Costs in connection with clinical trials and performance evaluations (in German)

Gebührenverordnung zum Medizinproduktegesetz und den zu seiner Durchführung ergangenen Rechtsverordnungen (Medizinprodukte-Gebührenverordnung)

Unofficial translation

Scientific and Regulatory Advice through the BfArM

The objective of advice procedures is to discuss with the BfArM scientific and regulatory matters regarding the development and licensing of medicinal products and medical devices. In this context applicants have the opportunity to obtain input with regard to questions related to administrative procedures which are in the remit of the BfArM as competent authority. Further information

Reporting of serious adverse events (SAEs) in clinical trials or performance evaluations for use by sponsors according to Section 3 sub-section 6 of the Ordinance on Medical Devices Vigilance (MPSV)

Please note
The Ordinance on the Recording, Evaluation, and Prevention of Risks Associated with Medical Devices (Ordinance on Medical Devices Vigilance, "Medizinprodukte-Sicherheitsplanverordnung", MPSV) of 24 June 2002 (Federal Law Gazette (BGBl. I 2002), p. 2131 no. 40), was amended by Article 4 of the Ordinance on the Making Available of Medical Devices and amending the Regulations governing Medical Devices of 25 July 2014 (Federal Law Gazette (BGBl. I 2014), p. 1227, no. 35).

The following notification obligations for SAE reporting have applied since 29 July 2014:

Investigators have to report all SAEs to the sponsor immediately. The sponsor of a clinical trial of a medical device that is conducted in Germany (and other countries) has to report SAEs to BfArM immediately or quarterly, depending on the following conditions.

Condition for reporting to BfArMCountry of occurenceTimeline for reporting to BfArMForm
A causal relationship between the SAE and the investigational medical device, a comparator device, diagnostic or therapeutic procedures performed as part of the clinical trial or other conditions of the trial conduct cannot be excludedGermanyImmediatelySingle report

German SAE Report Form

Please send to MPSAE@bfarm.de
All other countries where the clinical trial is performedImmediatelySummary table

MEDDEV 2.7/3 SAE report table

All SAEs shall be documented using the same Excel file, in a cumulative manner, using the same Excel sheet.

Please send to MPSAE@bfarm.de
A causal relationship between the SAE and the investigational medical device, a comparator device, diagnostic or therapeutic procedures performed as part of the clinical trial or other conditions of the trial conduct can be excluded


AllQuarterlySummary table

MEDDEV 2.7/3 SAE report table

Please complete the MEDDEV Excel sheet as outlined above.

Please send to MPSAE@bfarm.de
All SAEsAllQuarterlySAE summary evaluation

Evaluation
Annex 3.1 complication rate

Please send to MPSAE@bfarm.de

Please observe our notes on completing the SAE summary evaluation


Regardless of the criteria mentioned in the table, the sponsor must report all SAEs occurring in Germany to the competent authorities of other contractual states of the Agreement on the European Economic Area immediately if the clinical trial is also being performed in those countries.

Important information for SAE summary evaluations
The evaluation should be sent concurrently with the next SAE summary table (MEDDEV 2.7/3 SAE report table) and should be updated every 3 months. For further information please observe our notes on completing the SAE summary evaluation.

BfArM expects significant comparative data from scientific literature or other sources for all serious complications that may be related to the use of an investigational medical device, including adverse events associated with the medical procedures involved, to be included in the quarterly SAE summary evaluation. In addition to literature data, data derived from the risk analysis or comparable sources may be used. Such comparative data is to be provided in the Excel spreadsheet “complication rates” or, where needed, in other chapters of the summary evaluation report.

BfArM generally requires that all SAEs are carefully evaluated, regardless of whether or not they are related to the investigational medical device or anticipated. Likewise, not only safety endpoint events but all SAEs have to be assessed with regard to patient safety and are to be compared to acceptable occurrence rates.

The sponsor must indicate criteria for benefit-risk evaluation during an ongoing trial.

Patient safety must be evaluated considering the entire medical procedure that is involved in the use of the device. This includes access complications as well as preexisting medical conditions (possible contraindications), complications when using the investigational device in combination with other devices and any other factors that may increase the risk for patients.

Benefit-risk evaluation in a clinical study means comprehensive evaluation of all events with relevance for the safe use of the medical device, irrespective of relation to the investigational device, the medical procedure involved or any other factor and regardless of whether they are anticipated or not.

Important information for completing the MEDDEV SAE Report Table
The MEDDEV table is to be completed consecutively. Please always fill in the complete information for each case. New findings / updates to already reported events with relevance for the assessment may be added at any time. Please indicate your entry as "modified" in such cases.

In the columns for dates please only enter pure dates in the "dd/mm/yyyy" format according to the MEDDEV specifications. Please avoid empty cells in cases where such information is available (e. g. in the column "Description of Event").

However, please do not make any formal changes such as:
• correcting spelling errors including punctuation
• adding and removing spaces and line breaks
• format changes

Such changes create duplicates in our SAE assessment process. Please note that this duplication of data may cause additional fees.

FAQs (available in German only)


Download reporting form and complete offline
If PDF documents cannot be viewed with Firefox, please save locally (right-click on link and "save target as") or click here.

German Single SAE Report

Changelog


SAEs that occurred outside of Germany
see MEDDEV 2.7/1 (European Commission website)