Incident (medical device)

An incident within the meaning of medical device law is an event in which serious patient harm has occurred during the use of a medical device and a causal product defect is observed or suspected.

The legally binding definition of an incident for Germany can be found in Article 10 of Directive 93/42 / EEC , in Section 29 of the Medical Devices Act (MPG) and in Section 2 of the Medical Device Safety Plan Ordinance (MPSV). The decisive factor in all cases is that the patient harm that has occurred is based on a product defect or at least cannot be ruled out at the time the incident occurred. A product defect is defined as a "malfunction, failure or change in characteristics or performance or improper labeling or instructions for use of a medical device".

Incidents in Germany are the competent higher federal authority, d. H. to the Federal Institute for Drugs and Medical Devices or the Paul Ehrlich Institute . Manufacturers, users such as B. Doctors, dentists or alternative practitioners, and pharmacists. The competent higher federal authority forwards the report to the manufacturer, who is responsible for investigating the incident. The manufacturer's statement to the competent higher federal authority includes an assessment of which corrective measures may be required. The competent higher federal authority checks and evaluates the test results of the manufacturer, u. a. also whether the measures announced by the manufacturer are appropriate. The assessment by the competent higher federal authority relates to the safety of future applications of the medical device under investigation and does not take into account questions of product and medical liability for past incidents.

In addition to the above-mentioned legal texts that are legally binding for Germany, there is also a European guideline, which was issued as a recommendation for the member states of the European Union. In addition to the requirements of the MPSV, the reporting criteria also include therapy failures and serious undesirable side effects.

According to MPSV, however, an incident must be distinguished from a serious adverse event (SAE). In the case of an SAE, according to the definition of the MPSV, the focus is not on the causality of patient damage to a product defect, but on the temporal correlation of any patient damage that has occurred or is possible with the use of a medical device. In the context of German medical device law, SAEs are only relevant and notifiable when conducting clinical trials . Reported SAEs are examined and assessed like incidents by the competent higher federal authority.

Web links

• Obligations to notify operators and users of medical devices according to MPG and MPSV - information brochure of the "MPG working group of the industrial associations" (MPG AG), May 2017
• Forms for reporting incidents by other distributors as well as operators and users provided by the BfArM

Individual evidence

1. ↑ Website of the BfArM ( Memento of the original from February 25, 2015 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. 
2. ↑ D. Wetzel., D. von Mallek communications on regulations of the medical device safety plan regulation , In: Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz , 2009, Vol. 52, pp. 577-578.
3. ↑ MEDDEV 2.12-1 rev 6: Guidance on a Medical Device Vigilance System (PDF; 303 kB)