LGT Institute

Technical documentation:

By signing a declaration of conformity and tagging its product with the CE certification mark, the distributor responsible guarantees that the product meets all the requirements stipulated by the relevant EU directives. This is a binding prerequisite for the sale of goods in the European Economic Area.

In the past few years, German authorities have been performing a increased number of controls to ensure that distributors adhere to the declaration of conformity documented by the CE mark. These official reviews are not announced until shortly before they take place, and can either merely focus on samples or go into great detail. The aim of these reviews is to make sure that those documents which must be archived according to the German Medical Devices Act exist in the original version, and that they are correct and complete.
In order to support our customers, we at LGTI train the producers, in addition to procuring and randomly sampling the necessary documents. These documents include model specifications, technical drawings, declarations of conformity, test reports for the stipulated tests, as well as the Material Safety Data Sheets (MSDS) which help conform to REACH.
Customer benefits:

You can be sure that you are fulfilling your documentation duties
  with due diligence, and that your documents will meet the official
  requirements – without having to deal with things in detail yourself.

You save time and money by letting LGTI take care of the
  documentation for you in the framework of the requested test.

Thanks to LGTI’s language competence and many years of
  experience, you can be sure that the requested documents are
  correct and complete.