Implementation of Medical Device Directive
Directive on medical devices
The Medical Devices Directive (93/42/EEC) is intended to harmonize medical device requirements within the EU. The CE marking of the medical device directive may be granted to a manufacturer who meets the requirements of the directive. The medical devices directive consists of 23 articles, 12 appendices and 18 classification rules. The directive is divided into three main categories: absolute requirements, rules and requirements. In Europe, the manufacturer itself classifies its equipment according to the MDD classification rules. The implementation of the directive is supervised by Valvira in Finland.
Declaration of Conformity for standard-sized products
All Lymed products manufactured and manufactured by Lymed Oy are CE labeled, medical grade I products. Products are non-sterile. With the CE mark, the manufacturer verifies that the product meets the essential requirements set in the Directive. Each standard-sized product is labeled with the CE mark.
Statement of Conformity for individually manufactured products
Lymed’s custom-made products meet the essential requirements of Directive 93/42/EEC and are always manufactured for a specific individual. Products are non-sterile. The name of the patient is always stated in the label inside the product. Lymed custom-made products are medical devices, as their need and use is controlled by the patient’s medical personnel. Lymed custom-made products can be ordered by both private and public sectors, as well as health care institutions. Lymed custom-made products are always made the same way, regardless of the ordering entity.
Exception to the directive
If a patient orders a Lymed custom-made product without the recommendation of their medical personnel, then the patient is solely responsible for the treatment and the product does not meet the medical device directive. Our product range in custom-made products for sport, wellness and animals, without the control and recommendation of medical personnel, do not meet the relevant essential requirements of the directive.