Total and partial joint replacements
Currently it must be assumed that all implantable joint replacements will be assigned to Class III in the future. So far, there has been no clear definition as to whether certain joints are excluded. The MDR significantly extends the range of joint replacements which had already been assigned to a higher risk class in 2005 when Directive 2005/50/EC came into effect. According to rule 8, partial joint replacements and implants for further joints will also be assigned to Class III. Manufacturers may be well advised to reflect whether their devices concern a joint in the medical sense of the definition, e.g. the carpal or tarsal bones or the mandibular joint.
Spinal disc replacement implants and implantable devices that come into contact with the spinal column
These implantable devices are assigned to Class III. However, the wording “implantable devices in contact with the spinal column” raises questions. Strictly speaking, this might also include bone cements used for vertebral correction, which have likewise not yet been excluded.
The exceptions listed in the MDR include components such as screws, wedges, plates, and instruments. However, the MDR has not yet clearly defined how to classify a rod system or screw system, and what exactly “wedges” are in the context of spinal surgery. It almost appears as if the exceptions listed in the previous paragraph concerning joint replacements had been simply copied into the following paragraph without any adjustments. Given this, further publications are needed to define the boundaries of this rule and its exceptions.