Do not threaten the health and safety of the public or steal ideas
Unsafe Personal Protective Equipment can cause serious injury and the manufacture of fakes could put you in jail
Unsafe Personal Protective Equipment
What is Personal Protective Equipment?
Equipment designed to protect the wearer, including face masks and gloves, are classified as Personal Protective Equipment (PPE).
It is important that the manufacturer of PPE complies with the Rulebook on PPE.
What is Intellectual Property?
Intellectual property includes trademarks and designs. If you copy a trademark or design without the permission of the owner you commit an offence.
In Serbia, intellectual property rights are protected by the Law on Trademark (“Official Gazette of RS”, No. 06/2020, Law on Industrial Design (“Official Gazette of RS”, No.104/2009, 45/2015, 44/2018) et al.
PPE categories
The legislation establishes three categories of PPE, based on the severity of hazard that the equipment offers protection from, rather than the complexity of the PPE itself. These categories are:
a) Category 1: PPE that protects from simple or minimal risks. Manufacturers are able to self-declare conformity. Examples of this category include items such as sunglasses and washing gloves.
b) Category 2: PPE that does not fall into Categories 1 or 3. These products require ‘type examination’ by a designated body, and manufacturers are able to self-declare on production control. In Serbia, the PPE rulebook prescribes that for all PPE, affixing the Serbian conformity mark (3A mark) containing the number of the designated body is obligatory for Categories 2 and 3. Examples of this category include high visibility jackets, bicycle helmets, hardhats and oven gloves.
c) Category 3: PPE where the hazard may cause serious harm to the health and safety of the user and includes hazards such as biological agents. Products must normally be ‘type examined’ and the production control system must be reviewed by a designated body, either through audit or sample testing. Examples of this category include items such as respirator masks and life jackets. All PPE for specific use to protect against the risk of COVID-19 including respiratory face masks, is category 3 PPE.
PPE or medical device?
Some types of products that appear to be like PPE may actually be regulated as medical devices if their intended purpose is to protect others from the user. For example, a face mask is a medical device if its intended purpose is to protect the patient from the doctor.
For some products, it may be difficult to assess if the product should be considered as PPE or medical device. The Chamber of Commerce has published guidance for these instances.
Small businesses
Within the context of COVID-19, small businesses, individuals, and organisations such as charities and schools are offering PPE for donation or sale. This includes ‘home made’ sewn or 3D printed PPE for both workplace and personal use. If such equipment is intended to provide protection and is declared as PPE, it is subject to the same regulations and market surveillance activities as PPE imported and manufactured in any other way.
Manufactor’s obligations
The obligations of PPE manufacturers include:
- Before placing PPE on the market, a manufacturer must ensure that it has been designed and
manufactured in accordance with the applicable essential health and safety requirements. These are
set out in the Rulebook on PPE - A manufacturer must also have had a relevant conformity assessment procedure carried out and
technical documentation drawn up; - Once this has been done, a manufacturer must draw up a declaration of conformity, ensure that the
declaration is available and affix the conformity mark to the PPE; - Manufacturers must keep the declaration of conformity and the technical documentation for 10 years
after the PPE has been placed on the market; - Manufacturers must ensure that procedures are in place for series production to remain in conformity.
Changes in the design or characteristics of the PPE and changes in the harmonised standards or in
other technical specifications by reference to which the conformity of the PPE is declared shall be
adequately taken into account; - When deemed appropriate with regard to the risks presented by PPE, manufacturers shall, to protect
the health and safety of consumers and other end-users, carry out sample testing of PPE made
available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming
PPE and PPE recalls, and shall keep distributors informed of any such monitoring; - The manufacturer must ensure that all PPE placed on the market bears a type and serial or batch
number, or other element allowing its identification. The manufacturer should also include its name,
registered trade name or registered trademark and postal address. Where the size or nature of the PPE
does not allow this then it may be provided on the packaging or accompanying documentation; - The manufacturer must ensure that PPE is accompanied by instructions and safety information as set
out in the Rulebook on PPE, which is clear, legible and in easily understandable Serbian.
Declaration of Conformity
A Declaration of Conformity is a document drawn up by the manufacturer which must in detail, among other things, contain:
- The specific product to which the declaration is referring; and
- The name and address of the manufacturer
and, where applicable, their authorised representative.
The Declaration of Conformity must be kept by the manufacturer for a period of ten years from the date on which the product was placed on the market. This declaration must be made available to the enforcing authority upon request.
An Authorised Representative is a person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. Manufacturers remain ultimately responsible for ensuring these tasks are carried out properly.
Penalties
A person committing an offence under the technical-product safety rules/or intellectual property legislation may be liable to a penalty. It is matter for the enforcement authority to decide whether prosecution is appropriate in each case taking into account the circumstances of the case and the enforcement authority’s own policies, operational procedures and practices. Should a prosecution take place, it is at the discretion of the court to decide the penalties imposed on the offender.
WHO CAN I CONTACT IF I NEED HELP?
If you have any questions about non-compliant PPE, unsafe PPE or violation of intellectual property rights please contact:
Ministry of Trade,
Tourism and Telecommunication
Sector of Market Inspection
E-mail: stopfalsifikati@mtt.gov.rs
Website: www.mtt.gov.rs
Ministry of Economy – Technical Regulations
Website: tehnis.privreda.gov.rs
The Intellectual Property Office
Website: www.zis.gov.rs
The respective Serbian authorities exchange information concerning dangerous products found on the market, including non compliant and unsafe PPE that could be fake. These alerts are placed on the rapid alert system for dangerous non-food products – “NEPRO”. They include information about the type of products found, the risks posed and the measures taken at national level to prevent or restrict their marketing.
Weekly reports of the alerts are available at www.nepro.gov.rs
Ministry of Trade, Tourism and Telecommunications