Information on CE or other requirements on this anodic coating process
A recent customer request for information was on the need for regulatory approvals for MICRALOX® coated aluminum products sold in the European Union. The following post is to help navigate this issue.
The determination of what regulatory requirements need to be met, for any jurisdiction, is the responsibility of the product manufacturer. There may be multiple regulations that need to be understood that belie a simple response to this question.
MICRALOX® is an anodic coating process for aluminum products that is integral to the article and therefore is not separate from the article to which it is applied. The determination of whether a final product can be sold, and under what regulatory requirements, is a function of the regulations on the product. Typically, medical devices and other instruments do require CE approval in Europe. A useful overview of the CE process can be found here: <a href=”https://www.gov.uk/ce-marking”>https://www.gov.uk/ce-marking</a> .
MICRALOX® is chemically an anodic coating, and is often used in coating orthopedic and surgical instruments and other medical equipment. MICRALOX® is chemically equivalent to decorative and hard coat anodizing except that molecules in the coating are partially converted from an amorphous phase to a crystalline phase. This phase change is what makes the coating more chemically resistant to high and low pH cleaning.
When reviewing the CE requirements, the determination of whether a product coated with MICRALOX® could be CE approved starts with whether such aluminum products are currently coated with conventional anodic or hardcoat coatings and are approved for use. If they are approved for use, then MICRALOX® does not require any additional regulatory requirements. There are a number of orthopedic instruments currently using MICRALOX® anodic coatings that are sold into the European Economic Area and have been CE approved.