legal aid in the market introduction of protection measures against Covid – 19 – firstname.lastname@example.org
Category: Personal protection equipment
The legal requirements for this product category are set out in:
- Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment
Conditions of sale in Poland
- carrying out a product conformity assessment procedure in accordance with Regulation 2016/425 on personal protective equipment,
- preparation by the manufacturer of a declaration of conformity for compliance with the health and safety requirements indicated in Regulation 2016/425 on personal protective equipment (the competent notified body should be involved in the conformity assessment process),
- obtaining a certificate confirming that the product complies with the relevant standards, issued by the relevant notified body (the list of bodies entitled to certification is available here: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34),
- CE marking.
Compliance with standards
Gloves protecting against biological agents such as viruses, bacteria and fungi classified as personal protective equipment category III according to Regulation (EU) 2016/425, shall meet the requirements indicated in the following standards:
- EN ISO 374-5:2016 (PL-EN ISO 374-5:2017-02) Protective gloves against hazardous chemicals and microorganisms. Part 5: Terminology and requirements for the risk of penetration of microorganisms,
- EN 420:2003+A1:2009 (EN 420+A1:2012) Protective gloves. General requirements and test methods.
Documents required for sale of protective gloves
- declaration of conformity for compliance with the health and safety requirements indicated in Regulation 2016/425 on personal protection,
- a certificate for the product confirming that the product complies with the above-mentioned standards.
Labelling of protective gloves
The outer packaging of protective gloves shall bear the following information:
- type name, batch or serial number or other information allowing the identification of the PPE (if the size or nature of the PPE does not allow it – the required information shall be indicated on the packaging or in the document accompanying the PPE)
- manufacturer’s data, name, registered trade name or registered trademark and a postal address at which the manufacturer can be contacted (if this cannot be indicated on the PPE – the manufacturer’s identity shall be indicated on the packaging of the PPE or in a document accompanying the PPE)
- importer’s data – in case of imported protective gloves – i.e. name, registered trade name or registered trademark and postal address at which the importer can be contacted (if this cannot be indicated on the PPE, importer’s data shall be placed on the PPE packaging or in a document accompanying the PPE),
- in accordance with the requirements of the standards indicated as applicable to that type of product
As a rule, medical devices and PPE are subject to 23% or 8% VAT rate. The rate depends on whether the product is assigned to the relevant Polish Classification of Goods and Services (PKWiU) end-group.