It is European law that is implemented in national law in the member states, in Germany by the Medical Devices EU Adaptation Act (Medizinprodukte-EU-Anpassungsgesetz/MPEUAnpG). The purpose of the law is to regulate the sale of medical devices and thereby ensure
- the safety, suitability and performance of the medical devices as well as
- the health and the necessary protection of patients, users and third parties.
The CE mark is a seal of approval for the medical device, the application of which proves that the required legal requirements have been met. The summary for the users is:
- Proven effectiveness
- Tested and monitored security
- Risk assessment of the ingredients
NAWA Heilmittel GmbH is certified according to the Medical Device Directive 93/42 / EEC, Annex II and EN ISO 13485: 2016 and is checked annually for compliance with the regulatory requirements.