Medical Devices Adviser are individuals who professionally inform healthcare professionals about medical devices or instruct them in their proper use. The legal basis for this role is § 83 MPDG (German Medical Devices Law)..
Core Responsibilities of the Medical Devices Adviser
The activities of a Medical Devices Adviser include in particular:
- providing professional information on medical devices
- instructing users in the correct and safe use
This is based on:
- The Intended Use of the product
- The Users Manual
- the manufacturer’s specifications, as well as relevant safety and performance information
All information must remain strictly within this defined framework. Statements or recommendations outside the intended use are not permitted. The same applies to product modifications: only changes that are intended or approved by the manufacturer may be addressed or recommended.
Specific Requirements in Practice
Particular care is required, especially for products that:
- are used over a long period of time
- are used by multiple user groups
- are applied in different environments
This includes, for example, rehabilitation aids. Typical risks include:
- fall and tipping hazards in mobility aids
- risk of pressure ulcers in positioning systems
- pressure points in orthoses
The Medical Devices Adviser must be aware of these risks and adapt their communication accordingly.
Communication and Compliance
The communication of a Medical Devices Adviser is subject to clear regulatory requirements:
- statements must be factually correct, verifiable and consistent with the intended purpose
- requirements of German Healthcare Advertising Law (HWG) must be observed
- Data Protection Requirements must be complied with
- internal compliance and quality management requirements must be followed
In particular, the following are not permitted:
- unsubstantiated claims
- exaggerated or misleading performance statements
Structured Approach to Field Activities
A Medical Devices Adviser’s visit should follow a clearly defined structure:
Before the visit:
- define the objective
- review current product documentation and safety information
On site:
- conduct a needs and environment assessment
- demonstrate the product and explain its use
- communicate warnings, contraindications, as well as hygiene and maintenance requirements
Instruction should be delivered in a way that ensures safe use is clearly understood – for example through follow-up questions or practical demonstration (teach-back method).
Completion:
- verify that safety-relevant functions have been understood
- clarify any open questions
Documentation
Following the visit, all relevant content must be documented in a traceable manner, in particular:
- date, location and participants
- device concerned
- content of the instruction
- open points and follow-up actions
Applicable data protection requirements must be observed for personal data as well as image and file material.
Role within quality management and PMS
The activities of the Medical Devices Adviser are integrated into the quality management system (QMS).
The Medical Devices Adviser:
- identifies product-related observations or irregularities
- documents them
- forwards relevant information in accordance with internal processes
This information forms an important basis for Post-Market Surveillance (PMS).
Distinction from the PRRC (Article 15 MDR)
Legal responsibility for regulatory requirements – particularly in the areas of:
- PMS
- Vigilance
- . Incident Reporting
lies with the manufacturer or the Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 MDR.
The Medical Devices Adviser:
- supports these processes through the provision of information
- does not assume regulatory responsibility keine regulatorische Verantwortungsfunktion
- does not perform legal assessment or classification of incidents keine rechtliche Bewertung oder Klassifizierung von Vorkommnissen vor
Handling of Observations and Incidents
The Medical Devices Adviser must:
- identify use-related issues, complaints or irregularities
- document them fully and in a traceable manner
- forward them internally without delay
In particular, potential safety-related issues must be escalated promptly. Further assessment and external reporting are carried out via the company’s established processes.
Expertise and Qualification
The role of a Medical Devices Adviser requires:
- appropriate expertise
- practical experience
- regular training
These qualifications must be demonstrable upon request and kept up to date on an ongoing basis.
Support from BEO BERLIN
BEO BERLIN supports companies with:
- the qualification of Medical Devices Advisers
- integration into existing QMS and PMS processes
- the audit-proof design of instruction and documentation processes
Please do not hesitate to contact us.
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