legal aid in the market introduction of protection measures against Covid – 19 – firstname.lastname@example.org
Category: Medical device
The legal requirements for this product category are set out in:
- Act of 20 May 2010 on medical devices (Directive 93/42/EEC),
- Regulation (EU) 2017/745 on medical devices.
Conditions of sale in Poland
- carrying out a product conformity assessment procedure in accordance with the regulations on medical devices,
- preparation by the manufacturer of a declaration, confirming that the product complies with the essential requirements,
- obtaining a certificate issued by a European Notified Body confirming that the product complies with the standard required for it (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
Medical gloves – as medical devices – shall meet the requirements of the following standards:
- PN-EN 455-1:2004 – Medical gloves for single use – Part 1: Requirements and testing for freedom from holes (or EN 455 – 1 : 2000 respectively),
- PN-EN 455-2+A2:2013-06 – Medical gloves for single use – Part 2: Requirements and testing for physical properties (or EN 455-2:2009+A2:2013 respectively),
- PN-EN 455-3:2007 – Medical gloves for single use – Part 3: Requirements and testing for biological evaluation (or EN 455-3:2006 respectively),
- PN-EN 455-4:2010 – Medical gloves for single use – Part 4: Requirements and testing for shelf life determination (or EN 455-4:2009 respectively)
- or ASTM D6319 (USA).
Documents required for sale of medical gloves
- declaration of conformity for compliance with the requirements for medical devices: either directive 93/42/EEC, or Regulation (EU) 2017/745 on medical devices.
- a certificate for the product, confirming that the product complies with the standards indicated above.
- In accordance with the requirements of the Act of 20 May 2010 on medical devices (Directive 93/42/EEC) / Medical Device Regulation (MDR)
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.