Kondrat and Partners
legal aid in the market introduction of protection measures against Covid – 19 –

egory: medical device


Legal requirements

The legal requirements for this product category are set out in:

  • Act of 20 May 2010 on medical devices, medical devices,
  • Regulation (EU) 2017/745 on medical devices.

Conditions of sale in Poland
  • carrying out the conformity assessment procedure and drawing up a declaration of conformity by the manufacturer that the device complies with the essential requirements,
  • ce marking of the product.
Compliance with standards

Medical masks – as medical devices – should meet the requirements of the sta
ndard:PN-EN 14683:2006 – Surgical masks – Requirements and test methods (or EN 14683:2005, respectively)

Documents required for the sale of masks
  • declaration of conformity for compliance with the requirements:
    • Regulation of the Minister of Health of 17 February 2016 on essential requirements and procedures for assessing the conformity of medical devices (Journal of Laws and Regulations) U. item. 211) or
    • Directive 93/42/EEC, or
    • Regulation (EU) 2017/745 on medical devices.
  • the declaration of conformity should confirm that the product complies with standard 14683:2006 (EN 14683:2005).
Marking of masks

In particular:

  • CE marking,
  • name and address of the manufacturer.
VAT rate

Medical devices are taxed at an 8% VAT rate.