Let's start from the beginning…
Really? Drapes and gowns are medical devices?
In the European Community drapes, gowns and clean air suits used in operating theatres are considered medical devices. Why? Because they live up to the official definition of what a medical device is.
Each of those drapes, gowns and clean air suits is:
- a medical article intended to be used for human beings for diagnosis, prevention, monitoring or treatment, among others
- The manufacturer is legally responsible for compliance with the MDD
- The products must meet Essential Requirements on safety, performance and labelling
- The safety requirements are focused on patients