What do we know about the standards governing the import of surgical gowns and sheets into the EU? This question will be answered by Benjamin Muminovic, a 23-year-old entrepreneur for whom “entrepreneurship has no limits”. In addition to being an investor, the Bosnian is also in the import of products in the medical field. He is also the owner of two start-ups in this field. For this reason, we seek here his expertise to remove the shadow points relating to the import of surgical gowns and sheets in the EU. Interview.
Mr. Muminovic Benjamin, what couldwe know in general about surgicalgowns and drapes?
Surgical gowns and sheets are part of the medical device. They are therefore used in the health field.
Just like in other countries, the European Union member countries are allowed to use them. But, this must be done in accordance with the standards mentioned in the Regulation (EU) 2017/745 of the European Parliament and Council of April 5, 2017.
In addition, there are gowns and sheets for lay use. Their purchase can be made by anyone and in any outlet. Most of these gowns and sheets are intended for use in places other than hospitals or clinics.
However, when a gown or sheet is used in the health care field, it is referred to as a surgical gown and surgical sheet, respectively. Otherwise, surgical gowns and drapes differ from regular gowns and drapes in their serviceability.
What are the particularities of surgical gowns, Mr. Benjamin Muminovic?
Particularities ? First, I will say that the surgical gown is simply a medical garment. It can still be called an isolation gown, medical gown or procedure gown. It is used by both nursing staff and patients and some visitors.
The particularity of surgical gowns lies in the fact that they are single use. Each of the medical staff is then required to have them, and this, in an individual way. Several advantages are linked to its use.
The surgical gown is one of the basic protection tools. Indeed, it protects the wearer (generally the staff) when he/she is in contact with other people (patients and visitors). This medical garment is also a clue to distinguish in a health center, the nursing staff from others.
It is true that there are three categories of surgical gowns: gowns for medical-hospital staff, for patients and visitors and for laboratories. However, they can bedividedintotwotypes:disposablegowns and reusablegowns.
Is there anything about surgical drapes that differentiates them from surgical gowns, Mr. Benjamin Muminovic?
Of course! Like surgical gowns, surgical drapes are also classified on the European Union’s medical device list. They serve as a cover for patients, but can be used in a variety of circumstances.
During surgery, for example, the surgical drape is placed either on the operating table or on the patient’s body or on certain equipment.
Apart from surgery, the medical sheet plays an important role during medical examinations. The purpose is to protect the instruments and reduce the risk of contamination as much as possible. For this reason, the European Union requires that sheets be sterile in the same way as gowns.
For the import of surgical drapes or gowns, my company DocShipper guarantees a tailor-made offer. This includes transport and other services such as storage, packaging, customs clearance and compliance.
What types of surgical gowns and drapes can be imported into the EU?
The European regulation on the import of surgical gowns and drapes sheds light on the types of products that can be imported into the European Union.
First, I would like to make a small clarification.
All medical devices used in health care facilities are classified into four classes. These are defined according to the health risk of the product.
There is Class I, that is, medical devices with a low risk. Next, there is Class IIa, which includes moderate-risk products such as contact lenses, while Class IIb includes high-risk products such as disinfectants. The last class, III, is composed of high risk products such as implants.
I would like to emphasize that the classification of a medical device is a function granted to the manufacturer of the product in question. However, the manufacturer must comply with the classification rules established by the DM directives.
In any case, surgical gowns imported into the European Union are generally classified as Class I and II DMs, while sheets are classified as Class I, as they are considered to be the same as crutches, i.e., low risk products.
Now I’ll come back to the question.
Speaking of the types of classes allowed in the EU, I can tell you first of all that surgical drapes and gowns to be imported into the EU must not be high risk or high risk products. Otherwise, they should not fall under any Class III.
Nevertheless, each of the imported products is subject to control. The most concerned are sterile products, i.e. those belonging to class II DM.
In most cases, the tests carried out reveal that gowns and sheets in this category present a high risk. To remedy this, a conformity assessment is required. In order to obtain less questionable results, this evaluation must be performed by a certified organization.
In contrast to sterile products, products that are declared non-sterile (class I DM) do not have to be tested, as the risk here is relatively low. However, the manufacturer of the product or the importer is obliged to prove that his goods comply with the regulations.
Some people talk about “CE marking” before import.
Muminovic Benjamin, what do youneed to know in concreteterms?
In the European Union, there are legal texts that condition the import of medical devices. Each of these laws follows the DM directives and is applied in all European countries. In fact, before marketing products, the legislation requires that they obtain a European conformity marking commonly called CE marking.
Is CE marking important, Mr. Benjamin Muminovic?
Of course! CE marked products are those that comply with the various directives put in place by the European Union for the health and safety of consumers.
The CE mark confirms that the imported products have been approved. They can therefore be sold and used without any risk of contamination.
However, to obtain the European Conformity marking, the manufacturer of the product must prepare a file. At his request, he must attach the documents that justify that his product effectively complies with the DM directives. If necessary, the markingisissued by a specialized institution.
What are the means to obtain the CE mark?
Note that the CE mark is not a certification mark. However, it is obtained at the end of a process defined by the EU DM legislation.
The first step in obtaining it is to classify the product according to whether it belongs to class I or II. Once completed, Class II MDs will be tested in a laboratory to assess their compliance with European standards.
In the second step, the manufacturer will have to install a QMS, which is a Quality Management System. For example, this can be an ISO certification. In this regard, the ISO 13485 certification is the most recommended for medical devices.
Once the necessary documents for the technical file have been collected in the third step, the appointment of a CE representative is carried out. This is particularly important for non-European importers. After this appointment, the medical device is registered, the declaration of conformity is prepared and the CE mark is affixed.
So what are the standards for importing surgical gowns and drapes?
The first standard that surgical gowns and drapes imported into the EU must meet is the harmonized EN 13 795 – 1:2019.
In addition, these products are subject to various evaluations. Each of these assessments is intended to verify the resistance of the DM concerned in a specific area.
For example, we note the EN 13938-1 evaluation. It consists in determining the resistance of a fabric to wet or dry conditions. This test is often accompanied by the EN 29073-3 evaluation, which determines the tensile strength of the fabric under the same conditions.
Any final words, Mr. Benjamin Muminovic?
It is a great pleasure to be received on a timeless subject.
I would like to point out, however, that the EU has additional requirements for gowns and sheets. The importation of these two medical devices into the European Union is therefore subject to certain regulatory standards.
Failure to comply with these will result in instant legal sanctions. However, it would be wise for each importer to comply with them, as it is a matter of the health of the European populations.