Julia Hoyer: Basically, medical devices are always subject to laws and regulations, which apply to both additively manufactured and conventionally manufactured medical products. The laws and regulations state that the latest information pertaining to a new standard must be addressed in a timely and relevant manner. This doesn’t necessarily mean that all companies will be able to achieve one hundred percent implementation, but they must include these guidelines in their design considerations. If a company cannot meet all the requirements, it must substantiate why certain aspects are not applicable to the product. As a Technical Inspection Association, we review and take a closer look at the situation. However, if a company has created a better solution for its device as it relates to the general safety and performance requirements and can justify its alternative approach to the applicable statute and regulations, it will be met with approval.
What is your experience when you visit companies? Do they understand and implement the relevant standards accordingly? Or are there moments when you must request adjustments and changes?
Schlagintweit: That depends on the company's focus. Some companies specialize in rapid prototyping or B2C, meaning the customer wants the company to quickly fabricate a scale model of a physical part or assembly, making certain characteristics and requirements not as imperative. Here, standardization and certification have different significance.
How do you develop a new standard?
Schlagintweit: To submit a proposal for a new standard, you can approach multiple committees including DIN (Deutsches Institut für Normung e.V., the German national organization for standardization) or ISO. For example, the Technical Committee 261 oversees additive manufacturing, while the TC 150 is all about implants. The two groups have recently created a “joint working group” that is developing a standard for additive implant manufacturing. The working group has many heated discussions and documents all events. This starts the process, which is followed by annotation phases and voting procedures. It can take months to years before the finished standard can be published.