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What is a medical device?

This concerns European law that in the member states has been converted into national law, in Germany into the medical device law (MPG).
The purpose of the law is it to regulate the circulation of medical devices and thereby to take care of

  • the security, suitability and performance of the medical devices as well as
  • the health and the necessary protection of the patients to ensure users and third persons
A medical device differs in its mode of action from pharmaceuticals. Medical devices act
  • not pharmacological
  • not immunological
  • not by metabolism
  • without receptor effect.
The CE-mark is thus a quality seal for the medical device whose application proves that the demanded legal requirements are fulfilled. The NAWA Heilmittel GmbH hereby documents the conformity of the medical device with the legal regulations.
For the NAWA Heilmittel GmbH results from that the obligation
  • to analyze, to evaluate and to minimize risks and side effects
  • to exclude or to reduce infection and contamination risks
  • to exclude or to reduce biological incompatibilities and endangerments
  • to provide safety and operating instructions completely and understandably
  • to observe qualities mentioned with the product
  • to evaluate medical devices clinically or diagnostically
  • to supervise and/or to let supervise the medical device and the manufacturer during the entire product life cycle.
Summary for the user from the medical device:
  • no pharmaceutical, no cosmetics
  • proven effectiveness
  • reviewed and supervised security
  • risk evaluation of the ingredients (active ingredients and auxiliary substances)
For quality and security in the interest of the users provides the compliance to internationally recognized standards, which is examined annually by independent side. These high requirements are also of importance with the selection of the suppliers and co-operation companies. Thus the continuously high quality is ensured during the entire production process. Additionally for product security and - improvement the ingredients and production processes are constantly controlled and optimized.
 
DIN EN ISO 13485:2003
The requirements of the quality of medical devices are defined in the DIN EN ISO 13485:2003. The quality management system of the NAWA Heilmittel GmbH is based on this standard.
 
Medical device guideline 93/42/EWG, appendix II
Die EC directive for medical devices and the medical device law in Germany set fundamental requirements on medical devices. It is differentiated here into four risk classes (I, IIa, IIb and III) to which a medical device must be assigned. All products of the NAWA Heilmittel GmbH are classified accordingly.
 
The NAWA Heilmittel GmbH is certified by medical device guideline 93/42/EWG, appendix II, and DIN EN ISO 13485:2003 and is examined annually for the fulfilment of the standards