Medical device consultant

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The medical device advisor (§ 31 MPG) is a national legal specialty modeled on the pharmaceutical advisor (§ 75 AMG) (only) in Germany and Austria (§ 79 Ö-MPG). The European medical device law does not provide for this function.

He informs "specialist groups" (§ 3 No. 17 MPG), ie members of the medical professions, the healing trade and health institutions about medical devices and instructs them in the proper handling of active medical devices according to Annex 1 MPBetreibV (§ 10 Paragraph 1 No. 2 MPBetreibV).

The rest of the instructions are regulated by Section 4 (3) MPBetreibV. Who does this is not regulated by law.

Its legal task is - via the medical device safety officer (§ 30 MPG) - to participate in the "medical device monitoring and reporting system" (§ 29 MPG).

The qualification of the medical device advisor must be proven and documented at regular intervals, usually annually, through training.

Legal framework

The area of ​​responsibility and the required qualifications are regulated in Section 31 of the Medical Devices Act. The following must then be present:

  • Completion of a scientific, medical or technical occupation or

(alternatively) at least one year of activity in which experience in providing information about the respective medical devices and, if necessary, in instruction in their use was acquired.

The medical device advisor must do this

  • Have knowledge of his legal duties and obligations (*)

(*) Breaches of duty by the medical device advisor will be punished with a fine of up to 30,000 euros

and yourself

  • keep up-to-date with the latest information on the medical devices he is providing information about or instructing in their use.

Section 31 of the Medical Devices Act stipulates that anyone who professionally provides specialist groups with information about medical devices or instructs them in their proper handling must prove their expertise to the competent authorities on request.

Training and job profiles

There is no legal professional profile for medical device advisor along with legal test criteria. Anyone who does not have a recognized training can complete a corresponding course at the relevant industry associations ( BVMed , Spectaris, etc.), the notified bodies (TÜV, Dekra, etc.) or, for example, at private academies analogous to the pharmaceutical consultant . Documentation of further training according to §30 and §31 MPG is of great importance here .

This qualification is a legal requirement for areas such as technical and sales field service or product specialists in the office and similar job profiles that deal with the transfer of knowledge about medical-technical products. Further qualifications are required depending on the technology and medical application.

Constant further training to keep knowledge up to date is not only relevant for liability reasons. As part of the audit for ISO 13485 , conformity with the MPG etc. is checked and can thus lead to a loss of marketability if the documentation is inadequate.

See also

Web links