Your regular update for technical and industry information
The new EU Medical Device Regulation (MDR) has now been published, and came into effect on May 25, 2017, in all European member states. The countdown is on. All medical devices falling under the scope of the MDR will need to be recertified by the end of the three-year transition period. In the new series, “MDR – in a nutshell,” our MDR insiders explain what this means for the industry in practice and which regulations need to be interpreted in more Detail.
Interpretation of the transition regulations is still subject of discussion. Given this, all statements made at the present time may be subject to change. For example, it is still unclear whether new product models which would be covered under the scope of a quality management (QM) EC certificate according to Annex V, but which had not existed when the MDR came into effect may actually be placed on the market (assuming QM-related EC certificates are treated in the same manner as product-related certificates).
The MDR includes two classification rules for active medical devices which result in the medical device being assigned to a higher risk class, and therefore should receive special attention.
Rule 11: Software
Rule 11 addresses software (presumably only stand-alone software). It leaves little scope for Class I software. Most software is assigned to Class IIa at the lowest. (In the case of Class IIa and higher, a Notified Body must be involved – TÜV SÜD will be happy to assist you.)
In case of a more “pessimistic” interpretation, many software products would even have to be assigned to Class III. This is the case if software may contribute to causing death or irreversible deterioration of a person’s state of health – irrespective of the probability thereof. IEC 62304 has already corrected this issue. However, the MDR unfortunately has not done so. Whether this issue will be put into perspective by appropriate publications remains to be seen.
Rule 22: Invasive control systems
According to rule 22, Class III now applies not only to automatic external defibrillators, but also to closed-loop systems which significantly determine patient management. There is a host of these systems on the market, which now need to be examined to see whether this rule will apply to them, including systems that control the temperature in baby incubators via skin sensors, systems that regulate ultrafiltration in dialysis depending on the patient’s blood pressure, and systems that automatically adjust ventilation patterns to the patient’s condition. Here too, many manufacturers are hoping for further publications that might bring clarity as to the classification boundaries of this rule.
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.