§ 83 MPDG: whoever informs professional circles about medical devices is a medical device adviser – with proven expertise, regular training paid for by the principal and a recording duty that reaches the PRRC

Key takeaways

• A medical device adviser is whoever performs the activity described in § 83(1) MPDG. Sales staff, application specialists and product trainers of a manufacturer or distributor fall under it as soon as they inform professional circles or instruct them in handling, including by telephone.
• „Fachkreise“ – professional circles – are under § 3 no. 2 MPDG „Angehörige der Heilberufe, Angehörige des Heilgewerbes oder Angehörige von Einrichtungen, die der Gesundheit dienen, sowie sonstige Personen, die Medizinprodukte herstellen, prüfen, in der Ausübung ihres Berufs in den Verkehr bringen, implantieren, in Betrieb nehmen, betreiben oder anwenden“ – members of the healing professions and trades, staff of health institutions, and anyone who professionally manufactures, tests, places on the market, implants, commissions, operates or uses medical devices.
• Expertise under § 83(2) MPDG has two routes: a completed vocational qualification „in einem naturwissenschaftlichen, medizinischen, technischen oder IT-kaufmännischen Beruf“ – in a scientific, medical, technical or IT-commercial occupation – plus device-specific training, or „eine mindestens einjährige Tätigkeit, die in begründeten Fällen auch kürzer sein kann“ – at least one year's activity, shorter in justified cases.
• § 83(3) MPDG distributes three duties: the adviser proves expertise to the authority on request, keeps „auf dem neuesten Erkenntnisstand“ – up to date – and „der Auftraggeber hat für eine regelmäßige Schulung des Medizinprodukteberaters zu sorgen“ – the principal ensures regular training.
• § 83(4) MPDG makes the adviser the first link in vigilance: reports from professional circles on „Nebenwirkungen, wechselseitige Beeinflussungen, Fehlfunktionen, technische Mängel, Gegenanzeigen oder sonstige Risiken“ – side-effects, interactions, malfunctions, technical defects, contraindications or other risks – are to be recorded and „unverzüglich dem Hersteller, seinem Bevollmächtigten oder deren für die Einhaltung der Regelungsvorschriften verantwortlichen Person schriftlich oder elektronisch zu übermitteln“ – forwarded without delay to the manufacturer, its authorised representative or their person responsible for regulatory compliance.
• § 94(2) MPDG sanctions the activity without expertise (no. 7), the missing proof (no. 8) and the incorrect or omitted recording and forwarding (no. 9); § 94(5): „Die Ordnungswidrigkeit kann mit einer Geldbuße bis zu dreißigtausend Euro geahndet werden.“
• The provision applies to every principal that has professional circles informed, with no size threshold; a manufacturer with five field staff carries it like one with five hundred.

A role nobody appoints and everybody has

Most officers under German law are appointed. The medical device adviser is not. § 83(1) MPDG defines the role through the activity: „Wer berufsmäßig Fachkreise fachlich informiert oder in die sachgerechte Handhabung der Medizinprodukte einweist (Medizinprodukteberater), darf diese Tätigkeit nur ausüben, wenn er die für die jeweiligen Medizinprodukte erforderliche Sachkenntnis und Erfahrung für die Information und, soweit erforderlich, für die Einweisung in die Handhabung der jeweiligen Medizinprodukte besitzt. Dies gilt auch für die fernmündliche Information.“ Whoever explains a device to physicians as part of a manufacturer's sales team, whoever instructs a nursing team as an application specialist, whoever answers a clinic's technical query from the back office, performs the activity and is thereby a medical device adviser, whether or not the job description contains the word.

This article reproduces § 83, § 3 no. 2 and § 94 MPDG as made available by gesetze-im-internet.de on 17 September 2026. According to the footnote there, § 83 has been in force since 26 May 2021.

§ 3 no. 2: who belongs to the professional circles

The activity is directed at professional circles, and § 3 no. 2 MPDG defines the term widely: „‚Fachkreise‘ Angehörige der Heilberufe, Angehörige des Heilgewerbes oder Angehörige von Einrichtungen, die der Gesundheit dienen, sowie sonstige Personen, die Medizinprodukte herstellen, prüfen, in der Ausübung ihres Berufs in den Verkehr bringen, implantieren, in Betrieb nehmen, betreiben oder anwenden“. Covered are therefore not only physicians and nurses but also a hospital's procurement department, an operator's medical engineering unit and the distributor that resells the device. Whoever gives technical information to any of these counterparts is informing professional circles.

§ 83(2): the two routes to expertise

§ 83(2) MPDG: „Die Sachkenntnis besitzt, wer 1. eine Ausbildung in einem naturwissenschaftlichen, medizinischen, technischen oder IT-kaufmännischen Beruf erfolgreich abgeschlossen hat und auf die jeweiligen Medizinprodukte bezogen geschult worden ist oder 2. durch eine mindestens einjährige Tätigkeit, die in begründeten Fällen auch kürzer sein kann, Erfahrungen in der Information über die jeweiligen Medizinprodukte und, soweit erforderlich, in der Einweisung in deren Handhabung erworben hat.“ – expertise is held by anyone who (1) has completed training in a scientific, medical, technical or IT-commercial occupation and has been trained on the specific devices, or (2) has acquired experience in informing about the specific devices, and where necessary in instructing in their handling, through at least one year's activity, which may be shorter in justified cases.

The first route requires two things: a completed qualification in one of the four fields named and, in addition, training „auf die jeweiligen Medizinprodukte bezogen“ – related to the specific devices. The qualification alone is not enough; the product training alone is not either. The second route replaces both with experience, „mindestens einjährig“, with the opening „in begründeten Fällen auch kürzer“. Both routes are device-specific: expertise exists for „die jeweiligen Medizinprodukte“, not in the abstract. Whoever moves from blood pressure monitors to ventilators needs the expertise for ventilators.

§ 83(3): proof, currency, and the principal's training duty

§ 83(3) MPDG: „Der Medizinprodukteberater hat der zuständigen Behörde auf Verlangen seine Sachkenntnis nachzuweisen. Er hält sich auf dem neuesten Erkenntnisstand über die jeweiligen Medizinprodukte, um sachkundig beraten zu können. Der Auftraggeber hat für eine regelmäßige Schulung des Medizinprodukteberaters zu sorgen.“ – the adviser proves expertise to the competent authority on request; keeps up to date on the specific devices in order to advise competently; and the principal ensures the adviser's regular training.

The third sentence is the one that reaches the company. The first two address the adviser; the third obliges the „Auftraggeber“ – the principal – and to „regelmäßige“ training. The Act names no interval. It does, in sentence 2, name the yardstick against which regularity is measured: the adviser is to be „auf dem neuesten Erkenntnisstand über die jeweiligen Medizinprodukte“. Every product change, every new instruction for use, every field safety notice shifts the state of knowledge and with it the training need. A principal that cannot evidence the training cannot evidence sentence 3.

§ 83(4): the first link in vigilance

§ 83(4) MPDG: „Der Medizinprodukteberater hat Mitteilungen von Angehörigen der Fachkreise über Nebenwirkungen, wechselseitige Beeinflussungen, Fehlfunktionen, technische Mängel, Gegenanzeigen oder sonstige Risiken bei Medizinprodukten aufzuzeichnen und unverzüglich dem Hersteller, seinem Bevollmächtigten oder deren für die Einhaltung der Regelungsvorschriften verantwortlichen Person schriftlich oder elektronisch zu übermitteln. Werden Medizinprodukte unter der Verantwortung des Importeurs in Verkehr gebracht, sind die Informationen nach Satz 1 diesem schriftlich oder elektronisch zu übermitteln.“ – the adviser records reports from professional circles on side-effects, interactions, malfunctions, technical defects, contraindications or other risks and forwards them without delay, in writing or electronically, to the manufacturer, its authorised representative or their person responsible for regulatory compliance; where devices are placed on the market under the importer's responsibility, to the importer.

This provision connects sales with the manufacturer's vigilance. What a physician mentions to a field representative in passing about a problem with the device is a report within the meaning of subsection 4, and it is „aufzuzeichnen“ – to be recorded – and forwarded „unverzüglich“. The addressee is the manufacturer, its authorised representative or „deren für die Einhaltung der Regelungsvorschriften verantwortlichen Person“ – the person under Article 15 of Regulation (EU) 2017/745, whose tasks under Article 15(3)(d) include the reporting obligations of Articles 87 to 91. The Article 87 MDR deadlines run from the manufacturer's awareness; an adviser who sits on a report does not move the deadline, but shortens the time the manufacturer has left.

§ 94 MPDG: three offences, one range

§ 94(2) MPDG lists as an administrative offence anyone who intentionally or negligently „7. entgegen § 83 Absatz 1 Satz 1, auch in Verbindung mit Satz 2, eine Tätigkeit ausübt, 8. entgegen § 83 Absatz 3 Satz 1 einen Nachweis nicht, nicht richtig oder nicht rechtzeitig erbringt, 9. entgegen § 83 Absatz 4 Satz 1, auch in Verbindung mit Satz 2, eine Mitteilung nicht richtig oder nicht vollständig aufzeichnet oder nicht oder nicht rechtzeitig übermittelt“ – performs the activity contrary to § 83(1); fails to provide proof under § 83(3) sentence 1 correctly or on time; records a report incorrectly or incompletely or fails to forward it on time contrary to § 83(4). § 94(5) MPDG: „Die Ordnungswidrigkeit kann mit einer Geldbuße bis zu dreißigtausend Euro geahndet werden.“ – a fine of up to thirty thousand euros. Sanctioned are therefore the activity without expertise, the missing proof to the authority and the faulty recording or late forwarding. The principal's training duty under subsection 3 sentence 3 is not separately named in § 94; what consequence its breach has, the Act does not say at this point.

What a manufacturer or distributor has to hold

Four items follow from the wording. First, a register of the persons who inform or instruct professional circles, including the back office, because subsection 1 sentence 2 expressly includes information by telephone. Second, per person and per device group, the proof of expertise under subsection 2, route 1 or route 2, so that it can be produced to the authority on request under subsection 3 sentence 1. Third, a training plan with records that evidences the „regelmäßige Schulung“ under subsection 3 sentence 3 and is tied to product changes. Fourth, a recording and forwarding route under subsection 4 that captures every report from professional circles with a date and leads to the manufacturer's responsible person.

In CIVAC the advisers can be kept as persons with a role, proof of expertise and training filed as dated documents per device group, training set as a recurring task and every report under subsection 4 created as a time-stamped task with forwarding evidence. It changes nothing about the duty itself. Whether a person holds the expertise for a particular device is decided by their qualification and experience; the platform records when that was checked, trained and forwarded.

Where this article ends

CIVAC is not a law firm and does not provide legal services within the meaning of the German Legal Services Act (Rechtsdienstleistungsgesetz). This article reproduces § 83, § 3 no. 2 and § 94 MPDG verbatim. Whether a particular activity is technical information of professional circles, whether a particular qualification belongs to the occupations named in subsection 2 no. 1, when a justified case for a shorter period under subsection 2 no. 2 exists and which training interval is regular in a given case is not decided by this text but by the principal vis-à-vis the competent authority.

Frequently asked questions

Does a medical device adviser have to be formally appointed?

§ 83 MPDG provides for no appointment. A medical device adviser is whoever „berufsmäßig Fachkreise fachlich informiert oder in die sachgerechte Handhabung der Medizinprodukte einweist“. The duties under subsections 1 to 4 arise with the activity.

Does § 83 MPDG also apply to telephone support?

Yes. § 83(1) sentence 2 MPDG: „Dies gilt auch für die fernmündliche Information.“ Anyone who gives professional circles technical information on a medical device by telephone needs the expertise under subsection 2.

How often must training take place?

§ 83(3) sentence 3 MPDG requires „eine regelmäßige Schulung“ – regular training – without an interval. The yardstick is in sentence 2: the adviser keeps „auf dem neuesten Erkenntnisstand über die jeweiligen Medizinprodukte“. Which interval is regular in a given case depends on how that state of knowledge changes.

What must the adviser do with a physician's complaint?

Under § 83(4) sentence 1 MPDG, record reports on „Nebenwirkungen, wechselseitige Beeinflussungen, Fehlfunktionen, technische Mängel, Gegenanzeigen oder sonstige Risiken“ and forward them „unverzüglich dem Hersteller, seinem Bevollmächtigten oder deren für die Einhaltung der Regelungsvorschriften verantwortlichen Person schriftlich oder elektronisch“; for devices under the importer's responsibility, under sentence 2, to the importer.

What fine applies?

Under § 94(5) MPDG „bis zu dreißigtausend Euro“ – up to thirty thousand euros – for the offences of § 94(2) nos. 7 to 9: activity without expertise, missing proof to the authority, faulty recording or omitted or late forwarding of a report.