Anyone who provides expert information to healthcare professionals or provides them with instruction in the proper handling of medical devices may only perform this activity if they have the knowledge and experience required for the respective medical devices. This also applies to information given over the telephone.
Skilled medical device consultants are those who have successfully completed training in a medical, science or technical profession and who have been trained in the use of the respective medical devices or who have gained experience in providing information on the respective medical devices. Medical device consultants must provide evidence of their knowledge and experience to the relevant government authority upon request. They must keep up to date with the latest knowledge about medical devices in order to be able to give expert advice. It is therefore important for medical device consultants to receive regular training.
The Medical Devices Consultant must record reports from healthcare professionals on side effects, malfunctions, technical defects or other risks of medical devices and immediately forward them in written or electronic form to the person responsible.
How do you become a Medical Device Consultant?
The qualifications for becoming a medical device consultant include a basic course, product training and annual refreshment. The basic course includes medical device law, tasks and duties, the product training covers product knowledge and instruction in the handling of products. The annual refreshment helps consultants to stay up to date with basic knowledge as well as with the latest product knowledge.
Tasks of the Medical Device Consultant
The different tasks of medical device consultants include the following: trial of medical devices, consultation to medical devices, qualification of experts and users, customer and product support, delivery and renting of equipment and doing internal system reporting, for example, feedback on medical products and services.
Medical Device Law
The purpose of the medical device law is to regulate the distribution of medical devices and thereby ensure the safety, useability and performance of medical devices as well as ensuring the health and safety of patients, users and third parties.
The medical device law is based on three different EU guidelines:
Medical Device Regulation MDR including Active implants and Medical devices and In Vitro Diagnostic Medical Devices Regulation.
This law sets rules for the placement and supplying of the medical devices and putting it into service in the European Union with the intention of human use. This law also applies to clinical investigations conducted in the European Union concerning these medical devices.
Medical devices are classified in different classes namely I, IIa, IIb and III, depending on the hazard potential and on the place and duration of use. The classification is made in accordance with Annex VIII.
The classification of medical devices into a risk class enables the manufacturer to determine which procedure of compliance assessment is to be carried out. Depending on the classification of the product, manufacturers must include a qualified person to prove conformity. At the end of the conformity procedure, the manufacturer issues an EU Declaration of Conformity for this product, in which they declare that the product meets the essential safety and performance requirements according to Annex I of Regulation (EU) 2017/745 and is in conformity with the European standards.
Obligations of a Medical Device Operator
The operator must fulfil the duties assigned to him under the medical device regulation in order to ensure the safe and correct use of the medical devices used in his health care facility by patients. The duties of an operator are also to be fulfilled by anyone who, on the basis of a legal obligation, makes medical devices available to patients for their own use or for use by third parties in a domestic or other private environment.
Trautmann, Skript zum Basislehrgang, Medizinprodukteberater §31 MPG