Enzymatica develops health care products in an environment, that is regulated by laws, regulations, directives and standards. The company’s procedures and documentation are formulated in accordance with the requirements applicable for respective health care product. Documentation requirements are applicable for the entire life cycle of the product to guarantee that the product lives up to its performance claims. In summary, we take responsibility for ensuring that our products are safe, maintain a high standard of quality and live up to their claimed performance.
In early 2020, ColdZyme® obtained recertification according to class III (MDD). In this recertification process, Eurofins reviewed the complete documentation and manufacturing processes for ColdZyme, and confirmed that the product meets the applicable regulatory requirements. During the year Enzymatica also focused considerable attention on updating processes in order to meet the stringent requirements for the new European regulatory requirements, the medical device regulation (MDR – 2017/745), which will come into force in May 2021. A significant component of the work within the scope of the quality management system was dedicated to preparing documentation to ensure that the medical device has the correct labeling and complies with national requirements in the new European markets that were added during the year.