Shoe Covers - medical device class I

#1
Dears,

Can somone advice me if SHOE COVERS (made of propylene) could be registered as medical device of class I as per MDr?
The relevant Declaration of conformity was issued on March 2021.

Morover is there a possibility to declare compilance with standard that address to surgical apparel as per EN 13975-2
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

These shoe covers are not sterile and are not intended to be sterilized before use.
Intended use of this medical device defined by Manufacturer: Shoe Cover (non-sterile) – is designed for the protection of medical personnel against dusts and body fluids/blood in hospitals.

best regards
jw
 
Elsmar Forum Sponsor
#3
Hi,

I have just found the following explanation in MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019)

"1.11. Shoe covers - Background On the EU market there are shoe covers sold at hospitals used for different purposes : • Shoe covers which are intended by their manufacturer to be worn by the nursing staff to limit cross contamination in operating theatre and care units. • Shoe covers for visitors which are intended to be worn by visitors to prevent patient’s contamination when they visit a patient.

- Outcome According to the section 3.3 of Meddev 2.1/4, the labelling of the product is crucial for its classification under the directive 93/42/EEC. “As a general rule, the principal intended purpose can be established as being the one of a medical device if the product is intended to be used in a medical context with the aim to provide protection of health and safety for the patient, regardless of whether the product aims simultaneously to protect also the user. Where a product is mainly intended to protect the person using it, irrespectively whether in a medical environment or not, it falls under Directive 89/686/EEC.” Consequently, shoe covers which are specifically intended by their manufacturer to be used in operating rooms, intensive care units or immunodepressed patients to protect the patient from potential contamination are medical devices. In application of rule 1, they are in class I. In this case, shoe covers are considered as being similar to surgeons' gowns and hats. On the other hand, shoe covers for visitors even in a hospital are products of control of environment."


But there is one another issue that bother me - how to perform the clinical evaluation of such medical device?

jw
 

dgrainger

Trusted Information Resource
#4
You will need to change your intended use to mention protection of the patient for it to qualify as a device.
At the moment, "...designed for the protection of medical personnel against dusts and body fluids/blood in hospitals" still looks like PPE.
 
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