Medical Device Consultant Training by § 83 MPDG

What is a medical device consultant?

In Germany, a medical device consultant is defined as a person who, as part of their professional duties, provides healthcare professionals with information about medical devices, instructs them on how to use such devices properly, or provides them with information about medical devices over the phone. This is legally defined in Section 83 of the Medical Devices Act Implementation Act (MPDG). This role requires proven expertise and experience. This expertise must be documented and maintained through regular continuing professional development. A comparable requirement is established in Austria by Section 48 of the Medical Devices Act (MPG).

Who is required to complete training as a medical device consultant?

Field Sales and Distribution

Product demonstrations for doctors, hospitals, and pharmacies. On-site instruction in product use.

In-House Sales and Customer Service

Providing information over the phone regarding usage, accessories, and compatibility. Written consultations also count.

Technical Service

Instruction, installation, and user training at the customer’s site. Repairs performed without consultation are not included.

Importers and Distributors

Anyone who makes medical devices available on the German market bears the same obligations as the manufacturer.

When is expertise in accordance with Section 83 of the MPDG considered proven?

Under German law (§ 83 MPDG), these activities may only be performed if the required expertise and experience are present. This expertise must be documented and regularly updated. Expertise is deemed to have been demonstrated if one of the two requirements is met, and in both cases, regular continuing education is additionally ensured:

Requirement	Description per § 83 MPDG
Education + Product Training	Completed education in a natural science, medical, technical, or IT-business-related profession, supplemented by product-specific training.
Professional Experience	At least one year of experience providing consultation and instruction on the respective medical devices. This period may be shortened in justified cases, such as for trainees.
Continuing education (always required)	Regular updating of specialized knowledge. Without documented continuing education, proof of qualification is not valid.

What the medical device consultant training at WQS covers

We cover exclusively the regulatory component. Product-specific training remains the responsibility of the manufacturer; only the manufacturer knows its product.

Fundamentals of Medical Device Law: MDR (EU) 2017/745, MPDG, distinction from pharmaceuticals and IVDs
Role and duties of the medical device consultant pursuant to Section 83 MPDG, including the obligation to provide evidence to the regulatory authority
Vigilance System (Post-Market Surveillance): Recording of adverse events, interactions, malfunctions, technical defects, and contraindications
Obligation to report: immediate written or electronic notification to the manufacturer, authorized representative, or PRRC
Interface with the Person Responsible for Regulatory Compliance (PRRC) pursuant to Article 15 of the MDR

How to become a Medical Device Consultant?

We would be happy to provide you with a non-binding offer for in-house or online training for your Medical Device Consultants. The target group is manufacturers, importers and distributors according to MPDG based in Germany or making products available on the market in Germany. Unfortunately, our engineering firm does not offer individual training.

Request a Training Course Now

We have been training manufacturers, importers, and distributors since 1993. More than 1,000 medical device consultants have already completed our training. Just let us know the number of participants and your preferred date.

Frequently Asked Questions About Medical Device Training

Medical Device Training

What is a medical device consultant under Section 83 of the Medical Devices Act (MPDG)?

A medical device consultant is any person who, as part of their professional duties, informs healthcare professionals about medical devices, instructs them on proper handling, or provides information about medical devices over the phone.

Does WQS offer training for medical device advisors?

Yes. We train closed groups in-house or online. The target audience includes manufacturers, importers, and distributors under the MPDG based in Germany, as well as companies that make medical devices available on the German market.

Who is required to complete training to become a medical device consultant?

All employees of manufacturers, importers, and distributors who advise or instruct healthcare professionals. This applies equally to field sales, office staff, customer service, and technical support. Providing information over the phone also counts as an advisory activity.

How is the required expertise under Section 83 of the Medical Devices Act (MPDG) demonstrated?

By completing a degree in a natural science, medical, technical, or IT-related business field in combination with product-specific training, or by having at least one year of professional experience in advising and providing instruction on the respective medical devices. In both cases, regular continuing education must also be ensured.

Must a medical device consultant provide proof of training?

Yes. Upon request by the competent authority, proof of training must be available at any time. The legal basis is Section 83 of the MPDG.

What topics does the WQS training cover?

We cover exclusively the regulatory aspects: fundamentals of medical device law, obligations under Section 83 of the MPDG, the vigilance system, reporting procedures for adverse events, malfunctions, and contraindications, post-market surveillance, and the interface with the PRRC. Product-specific training remains the responsibility of the manufacturer.

Does the requirement for a medical device advisor also apply in Austria?

A comparable requirement is set forth in § 48 of the Austrian Medical Devices Act (MPG). For the German market, § 83 MPDG applies.

What happens if there is no proof of training?

The role of medical device consultant may not be performed without proven expertise. A lack of proof constitutes a finding in an regulatory audit and calls the entire sales organization into question.

What distinguishes the medical device advisor from the PRRC?

The PRRC, as defined in Article 15 of the MDR, is responsible for ensuring compliance with regulatory requirements at the company level. The medical device advisor works at the interface with the professional community and immediately forwards reports to the manufacturer, authorized representative, or PRRC. Both roles are interrelated but are not interchangeable.

This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.