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06.06.2019

Long live the SIBA

The safety officer for medical devices also exists within the new MDR. But are the tasks of the RP, the "responsible person", comparable? We make the comparison in the areas of post-market surveillance and vigilance and identify differences and new tasks.

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The future of the Safety Officer for Medical Devices according to the German Ordinance on Medical Devices (MPG) §30 was initially unclear with the planning of the new regulation. After the appearance of the MDR, however, it became clear: it still exists in medical technology. But beware, the Safety Officer (SIBA) according to MPG and the "Responsible Person" (RP) in the new MDR are only comparable at first glance and will in future cover many more tasks than before.

We make the comparison in the areas of post-market surveillance and vigilance and identify differences and new tasks.

 

Requirements / proof of expertise

For the safety officer the German Ordinance on Medical Devices (MPG) requires per §30


1.            a university education in natural sciences, technology or medical field OR any othertraining that enables the SIBA to perform its tasks AND

2.            at least two years professional experience.
 

The "responsible person" of the MDR must present his or her expertise on
 

1.            university education in law, medicine, pharmacy, engineering or any other relevant scientific discipline and one year of specific professional experience (regulatory or QM related to medical devices) or

2.            four years relevant professional experience (regulatory issues or QM in connection with medical devices).

 

In a nutshell:

A university education requires only one year of professional experience from the person in charge (MDR) and the field of approved courses of study is broader compared to the safety officer.

If you do not have a university degree, the responsible person (MDR) must have four years' professional experience. No training is required. The safety officer, on the other hand, needs training to enable him to carry out his duties and two years' professional experience.

 

Duties

Here the differences between SIBA and RP become very clear. The MPG requires the safety officer "only" to deal with reporting risks: collect data, evaluate and coordinate necessary measures.

In the MDR, the definition of the term and the article heading already clearly differ from the security officer: "Article 15. Person responsible for regulatory compliance ". The scope of duties includes the responsibility for
 

1.            the verification of conformity of the products before release,

2.            drawing- up and keeping up to date the technical documentation,

3.            post-market surveillance,

4.            the fulfilment of the reporting obligation for

               a.            Reporting of serious incidents and field safety corrective

                              actions (Article 87)

               b.            Reporting trends (Article 88)

               c.            Analysis of serious incidents and field safety corrective

                              actions (Article 89)

               d.            Analysis of vigilance data (Article 90)

               e.            Implementing acts (Article 91),

5.            in the case of investigational products, declare that the investigational product meets the essential safety and performance requirements except for the performance to be demonstrated in the clinical trial.


The tasks of the previous security officer thus correspond largely to those of the responsible person (RP) with regard to vigilance mentioned in point (4).

With points (3) and (4), the responsibility of the RP (MDR) extends over the first and second sections of Chapter VII of the MDR, which bears the long title "Post-market surveillance, vigilance and market surveillance" and thus already describes the three sections.

The first section, "Post market surveillance" (PMS), which is reflected in task item (3) of the responsible person, calls for a surveillance system (Art. 83), a plan (Art. 84) and a report (to be updated regularly) (Art. 85 and 86) for the PMS over the entire life cycle of a medical device. Art. 83 requires, inter alia, that

 

1.            the system is part of the quality management system,

2.            data on quality, performance and safety throughout the lifecycle of the

               product are collected actively and evaluated,

3.            the data are used in particular for the following purposes:

               a.             Updating risk management

               b.             Update of labelling (incl. instructions for use)

               c.             Update of the clinical evaluation

               d.             Updating the short report on safety and clinical

                               performance (Art. 32)

               e.             Determination of possibly necessary measures

                f.             Improvement of usability

               g.             as a contribution to the monitoring of other products,

                               where appropriate

               h.             Detection and reporting of trends.
 

The second section "vigilance" has already been briefly outlined and deals with the activities in case of serious incidents, corrective actions in the field, and trends towards them.

The third section, "Market surveillance", is addressed to the competent authorities, but a look at it is always worthwhile.

The PMS serves to ensure the performance and safety of the medical device after its market launch. A central element of the PMS is the Periodic Safety Update Report (PSUR) (Art. 86), which bundles information from market surveillance (complaints, trends, reports, etc.). This report is updated either annually (from Class IIb) or biennially (IIa). For Class I medical devices, only a report to be updated as necessary is required.

Post Market Clinical Follow-up (PMCF) is a further component of PMS. In the MDR, manufacturers are obliged to provide clinical proof of performance for each medical device - i.e. the manufacturer must plan whether the data available in the clinical evaluation are sufficient in the sense of follow-up or whether further follow-up studies are to be carried out and, if so, what type they should be. Since the risk profile and the safety and performance of the medical device can change even after it has been placed on the market, it is necessary to update the clinical data and thus also the PMCF plan as an interface between clinical evaluation and PMS over the entire life cycle of the medical device.

Which regulatory requirements can be applied?

On the one hand, you will find previous regulatory requirements, which you can, of course, also apply on a transitional basis: MEDDEV guidelines all around PMS, clinical evaluation and clinical studies, as well as the standard EN ISO 14155. In the context of the MDR there are already detailed specifications for the requirements in the legal text itself, and in addition to the EN ISO 14155 for the execution of clinical studies there is also a document by the ISO and the responsible standard committees on PMS in work, the ISO/ AWI TR 20416.

Are you insecure or do you lack the necessary resources? As a Clinical Research Organisation (CRO), seleon supports you systematically, safely and reliably with the necessary competence. Take advantage of our wide range of services and many years of experience to adapt your processes, train your employees or implement entire projects.

 

Also good to know

Neither the safety officer nor the responsible person may be disadvantaged by their work.

According to the MDR, small and micro enterprises do not have to hire a responsible person, but have one available at all times. However, consider the unannounced audit aspect! The role of the responsible person does not have to be carried by one person either, it may be divided between several shoulders.

In this post only a part of the tasks of the responsible person according to MDR were considered (Article 15 (c) and (d)). However, the items relating to conformity assurance of medical devices and technical documentation are also part of the VP's range of tasks. Is it getting too confusing for you? Here, too, we are happy to advise you with our many years of experience.

 

 

Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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