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Medical Product Legislation

This is also a very complex legal area. Only the governed definitions and definitions for terminology of the § 3 MPG (Medical Product Legislation) span four pages. In “short” a medical product or device can be defined as follows:

Definition of Term: Medical Product/Device

The term medical product is applied to all individual or connected tools, equipment, devices, substances or other objects, including the sound functioning of the medical product and applied software, which was intended by the producer to be employed for humans using their functions for purposes of detection, prevention, observation, treatment or relief of illnesses; the detection, observation, treatment, relief or compensation of injuries or disabilities, or for the examination, the substitution or for changing the anatomic structure or a physiological process or contraception control; and whose intended main effect in or on the human body cannot be achieved by pharmacologically or immunologically active agents nor by the metabolism, whose effect however can be supported by such means.
(Excerpt from § 3 MPG)

This includes e.g. pacemakers, orthopedic screws, artificial joints, stents, catheters, etc.
All medical products/devices are subject to a comprehensive licensing procedure. These are also regulated in the MPG. EU guidelines had to be implemented primarily in relation to this.

Liability in relation to defective medical products

Medical product liability is a main focus for the Heynemann law firm. Liability for defective medical products depends on the product liability legislation.

If for example a pacemaker is defect it must be checked whether a defect exists for the whole product line. If a hip replacement or an orthopedic screw break it must be examined whether a material defect exists. Is this the case and if patient injury results from this, e.g. because the pacemaker or artificial hip must be replaced, the patient is entitled to compensation and damages. We contact the producer or distributor of the medical product concerned and claim compensation and damages for the patient. If it has been established without a doubt that a material defect exists, and this is acknowledged by the opposing party, it remains to define the amount due for compensation and damages. Generally, the medical device producers are in favor of a fast extrajudicial settlement of the claim as it is not in their interest to discuss the quality of their products in the courts or in the public. At the same time some medical device producers will try to compensate patients with sums that are far too small. Therefore you should definitely make use of professional legal support so that your entitlements, especially with regard to possible future damage or injury, can be ensured.

In relation to individual defect medical products or devices see also:

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