Medical Device Safety Representative: this role is required under the Medical Devices Act; however, since May 2021, this has only applied to manufacturers of in vitro diagnostic (IVD) devices, and no longer to manufacturers of medical devices.
The Safety Representative was a ‘German invention’ that could not be directly derived from European directives such as the Medical Devices Directive.
The now applicable Medical Devices Regulation (MDR) provides for a comparable role in the form of the Responsible Person. In this specialist article on the Responsible Person, you will learn about the tasks, responsibilities and competence requirements that this new role must fulfil.
Regulatory Requirements for the Medical Device Safety Representative
The Medical Devices Act (MPG) stipulates in Section 30 (German) that companies based in Germany must appoint a person as a safety representative and notify the authorities of this appointment.
a) Duties of the Safety Representative
The duties of the medical device safety representative include:
- Collecting and evaluating reports on risks associated with medical devices,
- as well as coordinating necessary measures (e.g. informing the authorities, informing users, recalls, corrective actions).
The MPG stipulates that they are responsible for fulfilling reporting obligations insofar as these relate to medical device risks. The legislator thus holds them personally responsible for fulfilling the relevant legal obligations.
b) Medical Device Safety Representative: Required Expertise
This person, as also required by the Medical Devices Act (MPG), must possess the necessary expertise. Specifically, the MPG requires that the safety officer’s expertise be demonstrated by
- a certificate of completion of a university degree in natural sciences, medicine or engineering, or
- other training that qualifies the individual to perform the aforementioned tasks, and (in both cases)
- at least two years’ professional experience.
Upon request, you must be able to provide the authority with proof of this expertise.
Tasks of the Safety Representative
As a medical device safety officer, you are constantly involved in a wide range of tasks.
a) Gathering Information on Risks
You are responsible for ensuring that information regarding the risks associated with your medical devices is gathered and assessed. So, examples of the information sources you should use include:
- Adverse event reports, such as those stored in a complaints database
- Calls and enquiries to the hotline
- Software errors
- Reports from authorities such as the BfArM and the FDA
- Service reports and spare parts orders
- Information from distributors
- Your own observations
- Information from training teams
- etc.
As the safety representative, you are part of the risk management team, which is obliged to carry out these downstream phases in accordance with ISO 14971.
b) Evaluate information and determine actions
All this information must be evaluated to determine whether it is safety-relevant and whether it requires further action. Examples of such actions include:
- Notifying the BfArM
- Informing customers, e.g.
- Prohibition of use
- Instructions on correct use
- Product recall
- Product update, upgrade or servicing
- Product improvement
- CAPA
- etc.
Please note that the term ‘recall’ is defined differently by the MPSV than it is in everyday language. Read here what a recall means for medical devices.
c) Coordinating Actions
You are not obliged to make the decision on the actions to be taken, but you are obliged to coordinate and report these actions. The actions can be as far-reaching as they are costly.
Future Requirements under the MDR
The future Medical Devices Regulation (MDR) expands the requirements for safety officers, who are referred to therein as “Qualified Persons”:
Competence: Formal qualification through a university degree in a scientific subject will be required. Alternatively, individuals may have “five years’ professional experience in regulatory matters or quality management systems”.
Scope of duties: Compared to the safety representative, the duties of the “Qualified Person” are expanded to include
- Assessing the conformity of products in an appropriate manner prior to batch release
- Preparation and regular updating of the technical documentation and the Declaration of Conformity
- Issuing of declarations in accordance with Annex XV, Chapter II, Section 4.1 for investigational devices
Responsibility and liability: Unlike the Qualified Person, the safety representative is not responsible for “compliance with legal requirements”. This raises new questions regarding liability for both the medical device manufacturer and the “Qualified Person”. Thus, a discussion on this can be found here (German).
