Lawmakers set out legal requirements.
We ensure proper, legally sound documentation.
By providing the declaration of conformity and labelling a product with the CE marking, the legal manufacturer guarantees that the product fulfills all requirements of any applicable EU regulation, serving as a binding prerequisite for distribution in the European Economic Area.
In recent years, the compliance with these declarations, as evidenced by the CE symbol, has been subject to increased scrutiny by enforcement authorities. These regulatory inspections are announced with minimal advance notice and they examine every detail through random sampling. They entail thorough verification of all documents that must be archived according to EU regulations, ensuring their originality, accuracy and completeness.
To support you, LGTI offers training, procurement and random inspections of the required ducuments. These encompass model specifications, technical drawings, declarations of conformity, test reports for standard testing requirements and Material Data Sheets (MDS). MDS help you to be in compliance with biocompatibility and the REACH regulation.