The Safety Officer according to §30 German Medical Devices Act
Safety Officer - a task for responsible people!
The Safety Officer, the needed skills and the duties are well-defined in the German Medical Device Law in §30. Having a look into the law, it is pretty sure that the Safety Officer is a person with broad knowledge and skills and, above all, a high awareness of responsibility to product and user/patient safety.
The scope of the SBA (Safety Officer) stretches from the development of medical devices and in-vitro-diagnostic Medical Devices to market surveillance within the European medical devices vigilance and reporting system. The main task is always the product safety, whether in the development and manufacture or later in the application.
Incident or not? - Report needed or not?
The Safety Officer has to cover the entire reporting obligations and the management of communication between manufacturer, distributors and legal authorities. Thus, it is primarily the job of the Safety Officer to decide on the need for reporting or, in extreme cases, the product recall.
Often this is exactly the question how to handle complaints or accidents in the market, and whether this is to be reported or not? consulting & more offers advice in those situations. Of course, we also support you with the installation of the relevant procedures in your organization.
Where is the Safety Officer situated in the organization?
Not everything is defined quite clearly by the German Medical Devices Act and its regulations. This is a good thing, because every company has a different structure.
The position of the safety Officer and the Medical Device Consultants (Medizinprodukteberater) in the organizational chart of the company, the involvement in the quality management system and the job descriptions should be carefully designed to fulfill the required tasks and safeguard the needed independance of the Safety Officer.
If you have questions about the function or the implementation of the Safety Officer, or even the stand-in arrangement is not yet defined, consulting & more will be glad to help.
