What is a Class 1 Medical device? (European Directive 93/42)
According to the European Directive CEE 93/42 a medical device is “any item, implant, substance or product utilised on its own or combined with other tools, computer software included, which will be utilised for:
- Diagnoses; prevention; checks; treatment or abatement of an illness;
- Diagnoses; checks; treatment or abatement of a handicap;
- Studies; substitution; modification of the anatomy or of a physiological process;
- Intervention in the birth process.
Whose principle function is to aid the process of administering pharmacological medicines to the human body which are not related to the immune system or to the metabolism.
Recognised as a Class 1 medical device:
Generic non electrical machinery (non-active) which does not penetrate into the human body or does not require invasive surgery;
Electric machinery (active) which are used to support patients or in diagnosis.
Who is the manufacturer?
The manufacturer is the physical person or the legal person responsible for the device project and production, its packaging and label and the introduction of the product under its name on the market.
European brand label CEE
The brand CE is obligatory on a medical device because the product needs to respect the European legislation. This brand allows the introduction of the products on the European Union market and gives the producer the right requirement he needs to follow in order for the product to be accepted as a CE brand.
CE branded products are a guarantee in terms of materials used and functionality, producing and testing process and traceability in terms of product circulation from the producer to the clients.
Advantages of Medical Device Class 1
By buying a medical device the buyer is entitled to a VAT discount on healthcare expenses.