CE stands for Conformité Européenne – in English: European Conformity. Being CE-marked means that Hedia conforms with the standards of the European Economic Area.
Hedia has been granted this CE status as a class IIb medical device, which allows us to place the CE marking on our product. CE marking is a sign of the highest quality: it ensures that we are always in line with the excellence that the European Union’s legislation requires.
Receiving the CE mark is proof of Hedia’s harmony with EU legislation on medical devices. The EU’s Medical Device Directive 93/42/EEC includes essential requirements of safety, performance and quality.
Accordingly, Hedia Diabetes Assistant can be marketed and sold legally throughout the EU and EEA, to its 500 million consumers.
The International Organization for Standardization (ISO) is an independent body that certifies international standardisation, having been given consultative status with the United Nations Economic and Social Council.
The ISO certification process for Hedia was carried out by TÜV SÜD, a business that has been undertaking inspections since 1906. TÜV SÜD is an international inspection and product certification service with locations based in about 50 countries.
Receiving certification to ISO 13485:2016 demonstrates Hedia’s ability to provide a medical device and related services that consistently meet customer and applicable regulatory requirements. The certification confirms that Hedia is able to meet the international requirements of ISO.