The new regulation defines more stringent requirements for quality management and documentation. You need...
✔ To have the risk and quality management systems audited by the notified bodies;
✔ To have good technical aids;
✔ To be protected against unpredictable consequences with respect to product liability.
Some practical examples...
✔ A defect representing a risk of death or personal injury occurred in one individual product. As a result, the manufacturer could be forced to recall the entire series if the production of each individual device was not documented during the assembly process.
✔ A manufacturer of display units used in the operating theatre needed to demonstrate that these units are leakproof. As a result, if the display is assembled using modern, computer-controlled tightening systems, the successful completion of tightening is documented during the process.
How to meet the requirements?
What is important to be aware of...
✔ 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 (the Association of German Engineers) warns that stringent regulatory requirements may delay or represent an obstacle to development processes in the sector. 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.
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