Vigilance reporting Requirements for Manufacturers and Authorized Representatives in Germany
Introduction
With the implementation of the EU MDR 2017/745 into national law the requirements for Vigilance reporting are more specific, and detailed than it was under the MDD/AIMDD.
There is no MDCG guidance available for Vigilance reporting under MDR, however the MEDDEV Guidance 2.12/1 rev 8 was updated in July 2019 to address the IMRDF/GHTF global guidance GHTF SG2 N54, and the updated Reporting Forms adopted by the NCAs 01st of January 2020, and they are still to be used.
This blog provides you an overview of Vigilance reporting requirements for Medical Device Manufacturers and Authorized Representatives in Germany under MDR 2017/745, MPDG and MPAMIV.
Reportable events per MDR 2017/745: Serious Incidents, Field Safety Corrective Action (FSCA), and Trend Reports
MDR 2017/745 Sentence 1 of Art. 87:
“Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following:
(a) any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88;
(b) any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.
The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 92.”
In addition, Art. 89 paragraph 5 requests the Manufacturer to submit via EUDAMED (System as per Art. 92) a final report on the reported events including findings from the investigation, conclusions and indicated corrective actions.
Art. 89 paragraph 8 regulates the information of the Users in form of a Field Safety Notice (FSN) about the FSCA, and that the draft of the FSN shall be submitted via EUDAMED to the evaluating Competent Authority or Coordinating Competent Authority, depending on the urgency.
The requirement for the Manufacturer to perform investigations on the reported serious incident and concerned device without delay, including a risk assessment and required field safety corrective actions, as well as the obligation to co-operate with the Competent Authorities and their Notified Body, if applicable, is laid down in Art. 89 paragraph 1.
Timelines for Reporting
Manufacturer’s and Authorized Representative’s Reporting Responsibility
Event | Description | Modalities | Timeline for Reporting to CA |
Serious Incident a) | Serious incident leading to the event of death or an unanticipated serious deterioration in a person’s state of health Single report | Forms via web application or email to mp-vigilanz@bfarm.de Report Incident Form BfArM will notify the Notified Body (MPAMIV § 10) | ≤ 10 days after the date on which the manufacturer becomes aware of the serious incident. |
Serious Incident b) | Serious incident leading to the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health Single report | Forms via web application or email to mp-vigilanz@bfarm.de Incident Report Form BfArM will notify the Notified Body (MPAMIV § 10) | ≤ 15 days after they become aware of the incident |
Serious Incident c) | Serious Public Health Threat single report | Forms via web application or email to mp-vigilanz@bfarm.de Incident Report Form BfArM will notify the Notified Body (MPAMIV § 10) | ≤ 2 days after the manufacturer becomes aware of that threat. |
Similar Serious incidents | Single report PSR (Periodic Summary Report) in case the following is met:
| Forms via web application or email to mp-vigilanz@bfarm.de Incident Report Form BfArM will notify the Notified Body (MPAMIV § 10) | Single Report as per Serious Incident a), b), c) PSR as per Agreement with the Competent Authority / the Coordinating Competent Authority |
FSCA | Field Safety Corrective Action | Forms via web application or email to mp-vigilanz@bfarm.de Recall Report Form BfArM will notify the Notified Body (MPAMIV § 10) | Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action in advance of the field safety corrective action being undertaken. |
Incident | any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect; | In Trend Reports | N/A |
Trend Report | Report on any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side- effects that could have a significant impact on the benefit-risk analysis | Informally by email to mp-vigilanz@bfarm.de BfArM will notify the Notified Body (MPAMIV § 10) | As trend is detected |
Country specific forms
- Incident Report -MIR Form 1
- FSCA / Recall Report Form 2
The German Legislation refers to the MDR 2017/745 with regards to requirements for Manufacturer and Authorized Representatives Vigilance reporting. Until EUDAMED is available, all reportable events as outlined above need to be submitted via web application or via email to: mp-vigilanz@bfarm.de
