MEDICAL PRODUCT

Kondrat and Partners
legal aid in the market introduction of protection measures against Covid – 19 – biuro@kondrat.pl

Disinfectant – medical device

 

Legal requirements
  • Act of 20 May 2010 on medical devices
Conditions of sale in the territory of Polish
  • carrying out the conformity assessment procedure and drawing up a declaration of conformity by the manufacturer that the device complies with the essential requirements
  • a certificate confirming that the product complies with the standards indicated in point 2 (issued by a Notified European Body)
  • CE marking
Compliance with standards

Disinfectants as medical devices should meet the following standards:

  • PN-EN 13624:2006 – Chemical disinfectants and antiseptics – Quantitative suspension method for determining the fungicidal action of chemical disinfectants of tools used in the medical field – Test method and requirements (phase 2, stage 1) (or EN 13624:2003, respectively)
  • PN-EN 13727:2012 – Chemical disinfectants and antiseptics — Quantitative suspension method for determining bactericidal action in the medical area — Test method and requirements (phase 2, stage 1) ( or EN 13727:2012, respectively)
  • PN-EN 14348:2006 – Chemical disinfectants and antiseptics ― Quantitative suspension method for determining the mycobacterial action of chemical disinfectants used in the medical field, including tool disinfectants — Test method and requirements (phase 2, stage 1) (or EN 14348:2005, respectively)
  • PN-EN 14561:2008 – Chemical disinfectants and antiseptics ― Quantitative carrier method for determining the bactericidal action of agents intended for medical field tools – Test method and requirements (phase 2, stage 2) (or EN 14561:2006, respectively)
  • PN-EN 14562:2008 – Chemical disinfectants and antiseptics — Quantitative carrier method for determining fungicidal or suicidal activity against fungi of yeast-like agents intended for tools used in the medical field — Test method and requirements (phase 2, stage 2) (or EN 14562:2006, respectively)
  • PN-EN 14563:2012 – Chemical disinfectants and antiseptics — Quantitative carrier method for determining the mycobacterial or suicidal effect on mycobacterial tuberculosis of chemical disinfectants used for tools in the medical field — Test method and requirements (phase 2, stage 2) ( or EN 14563:2008, respectively).
Documents required for sale
  • 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.
  • a certificate for the product confirming that the product complies with the standards indicated above
Marking
  • CE marking
  • name and address of the manufacturer
Purchase procedure of the Ministry of Health
  • The Minister of Health or his authorised entities may purchase medical devices if they are authorised in countries other than the Member States of the European Union and the Member States of the European Free Trade Agreement (EFTA), parties to the Agreement on the European Economic Area
Exceptional authorisation to use the products[1]
  • It shall rely on the placing on the market and use of a medical device for which conformity assessment procedures have not been carried out confirming that the device complies with the essential requirements relating there to it
  • The placing on the market and use of products in this mode is an exception to the rules and must therefore only be used in exceptional situations
  • An application for a decision to admit devices under a special procedure must be justified precisely by the need to save the life or health of the patient or to protect public health
  • A closed directory of entities that can apply to the President of urpl for a decision in this way: healthcare provider, consultant in health care, President of the Agency for Evaluation of Medical Technologies or President of the National Health Fund.
Export rules
  • No later than 36 hours before the intention to export or dispose of products for disinfection outside the territory of Polish, the governor responsible for the trader's registered office or place of residence must be informed therewith a list and quantity of products,
  • the Governor may submit an application to the Prime Minister to prohibit the export or disposal of these products outside the territory of Polish.
VAT rate

As a general rule, medical devices and PPE are subject to a 23% or 8% VAT rate. The amount of the rate depends on the assignment of the product to the correct final grouping of the PKWiU.

 

[1] Joke. Whereas Article 15 (1) of Regulation (EEC) No 2 1 of the Medical Devices Act

Holler Box