Legal requirements

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,
• Annex II to the Ordinance of the Minister of Labour and Social Policy of 26 September 1997 on general regulations of safety and hygiene at work.

 

Conditions of sale in Poland

• carrying out the product conformity assessment procedure in accordance with Regulation 2016/425 on personal protective equipment,
• the 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 relevant 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

The protective suit shall comply with the requirements of EN 14126:2003 standard on clothing, providing protection against infectious agents.

 

Documents required for sale

• Declaration of conformity to the requirements of Regulation 2016/425 on personal protective equipment,
• a product certificate confirming that the product complies with the relevant standard.

 

Labelling

• CE marking,
• type name, batch or serial number or other information allowing the identification of the protective suit (if the size or nature of the product does not allow it – the required information shall be included on the packaging or in the accompanying document),
• manufacturer’s data,
• importer’s data,
• in accordance with the requirements of the relevant standard.

 

VAT rate

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.