The EU Medical Devices Regulation (MDR) requires all manufacturers in the EU to classify their medical and medical technology devices in risk classes and to have their risk and quality management systems audited.
The documentation requirements mean considerable work for many manufacturers. However, good technical aids are available. And the EU regulation also protects manufacturers against unpredictable consequences with respect to product liability.
For example, if a defect representing a risk of death or personal injury occurred in one individual product, the manufacturer could be forced to recall the entire series if the production of each individual device was not documented. There is already a judgment of the European Court on this matter (C 503/13) (see QR code above). Such recalls are extremely complex and costly.
The new regulation defines more stringent requirements for quality management and documentation. Atlas Copco can provide advice and support in this context.
One example: if a display is assembled using computer-controlled nutrunner systems and the results are documented, it may be possible to omit the tightness test. This could reduce the amount to be invested in costly test equipment.
In the field of tightening, our ToolsNet 8 software package can collect a wide variety of data quite independently of bolted assembly. We can also document traceability and generate unambiguous barcodes for this purpose. In addition, we have comprehensive process optimization know-how which allows us to help any industrial company save costs, become more flexible and safe guard its competitiveness.
The Federal Medical Technology Association and other associations have already stated that up to one-third of manufacturers in Germany may be overwhelmed by the requirements of the MDR and disappear from the market. In a recent study on trends and prospects in the medical technology sector, VDI warns that stringent regulatory requirements may delay or represent an obstacle to development processes in the sector. Do you agree? I am aware of these figures. Especially small and medium-sized companies face a considerable challenge. However, it is important not to despair but to face up to the challenge and to obtain appropriate information.
Over the past few months, we have prepared basic training units to inform our customers of what they need to do and how they can protect themselves. Or rather how they can meet the requirements at the same time as keeping costs down to a reasonable level.
A manufacturer of display units used in the operating theatre needed to demonstrate that these units are leakproof.
If the display is assembled using modern, computer-controlled tightening systems, the successful completion of tightening is documented during the process.
In an ideal case, this means that the manufacturer no longer needs to carry out a tightness test on the monitor. Using simple tightening tools, this would not be possible and the entire process including tightness test would be much more complex and costly.
This means that the manufacturer may be able to avoid the need for a tightness test by documenting bolted assembly. As a result, it would not be necessary to invest in expensive test equipment.
As a general point, we take a close look at all processes in order to find a way of ensuring and documenting quality as simply and inexpensively as possible.
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