The new EU Medical Device Regulation, short “MDR”, was published on May 5, 2017 and came into force on May 25, 2017.
The original three-year transition period set for manufacturers of already approved medical devices has been extended by one year due to the Covid-19 pandemic and the resulting need for vital medical devices and the additional burden on health facilities and national authorities.
This new EU medical device regulation contains new, stricter guidelines for manufacturers, importers and retailers, which are intended to ensure higher standards of quality and safety for medical devices.
Compared to the previously applicable EU directives, for example, the scope of the regulation has been significantly expanded, which means that even more products are now affected by the rules of the MDR (such as implants for aestheticpurposes or colored contact lenses). Manufacturers must now also provide a “qualified person” who is ultimately responsible for fulfilling the requirements.
In addition, all products, including those that have already been approved, must be reclassified according to risk, duration of contact and invasiveness and evidence of clinical investigations must be submitted.
One of the most important new guidelines is the obligation to use unique product numbers “UDI” (unique device identification), which are intended to simplify traceability for manufacturers and authorities and thus enable medical devices tobe recalled quickly and efficiently in the event of safety risks.
The UDI code is a unique (alpha) numeric character string that is applied to the medical device as a laser marking, for example, is human-readable (plain text) and machine-readable and must remain visible throughout the product’s entire life cycle.
Our ultra-short pulse laser CEPHEUS with our unique PERMAblack process is suitable for precisely this marking of medical instruments. It enables the surface to be blackened with very little heat influence on the material and creates nanostructural changes on the surface of the metal in which the incident light is absorbed.
As a result, the marking is consistently black regardless of the viewing angle and remains stable even under strong light. In addition, the metal remains corrosion-free despite the lettering, which means that the lettering is also resistant to passivation and cleaning in the autoclave.