legal aid in the market introduction of protection measures against Covid – 19 – email@example.com
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 the territory of Poland
- carrying out the 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 requirements of Regulation 2016/425 on personal protective equipment;
- obtaining a certificate issued by a European Notified Body, which confirms that the product complies with the relevant standard (information on relevant standards can be found below; 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=155501);
- CE marking of the product.
Compliance with standards
Half-masks – as personal protective equipment – shall meet the requirements of the standard:
- PN-EN 140:2001/Ap1:2003 – Respiratory protective devices – Half-masks and quarter masks – Requirements, testing, marking (or EN 140:1998 EN 140:1998/AC:1999 respectively); or
- PN-EN 149+A1:2010 – Respiratory protective devices – Filtering half-masks to protect against particles – Requirements, testing, marking (or EN 149:2001+A1:2009 respectively).
Documents required for sale
- declaration of conformity of compliance with the requirements of Regulation 2016/425 on personal protective equipment,
- a product certificate confirming that the product complies with the relevant standard.
- CE marking,
- type name, batch or serial number or other information allowing the identification of the mask (if the size or nature of the mask 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 (number of the standard, name of the half-mask, protection class, manufacturer’s data).
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.