MEDICAL GLOVES

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

MEDICAL GLOVESC
ategory: 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 a procedure for assessing the conformity of the product in accordance with the provisions on medical devices,
  • a declaration by the manufacturer confirming that the device 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);

Note! Many products with inappropriate certificates have appeared on the market, for example certificates issued by unauthorised entities or complying with standards that are not desirable in a given country. It is important to check that the product is certified before it is placed on the market.

  • CE marking,
Compliance with standards

Medical gloves – as medical devices – should meet the following standards:

  • PN-EN 455-1:2004 – Disposable medical gloves – Part 1: Requirements and tests for the absence of holes (or EN 455 – 1 : 2000, respectively),
  • PN-EN 455-2+A2:2013-06 – Disposable medical gloves — Part 2: Physical characteristics requirements and tests (or EN 455-2:2009+A2:2013, respectively),
  • PN-EN 455-3:2007 – Disposable medical gloves — Part 3: Requirements and tests in biological evaluation (or EN 455-3:2006, respectively),
  • PN-EN 455-4:2010 – Disposable medical gloves — Part 4: Requirements and tests for the determination of shelf life (or EN 455-4:2009, respectively)
  • astm D6319 (USA).
Documents required for the sale of medical gloves
  • declaration of conformity for compliance with the requirements for medical devices:
  • 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 in point 2.
Labelling of medical gloves
  • CE marking,
  • the name and address of the manufacturer,
  • marking in accordance with the above standards.
Purchase procedure of the Ministry of Health

Due to the prevailing pandemic, specific arrangements have been provided for the supply of personal protective equipment and medical devices.

The Ministry of Health has introduced a special purchasing procedure under which products can be purchased in accordance with the guidelines of the national consultant in the field of infectious diseases.

In accordance with this procedure:

  • it is possible to sell medical gloves before the conformity assessment is completed and without the CE marking,
  • medical gloves must, however, comply with the guidelines of the national consultant in the field of communicable diseases, including in particular as regards the above-above standards,
  • the outer packaging shall indicate that the product may be used only during the period of increased epidemic and epidemic risk, but not more than 30 days after the end of the epidemic in relation to SARS-CoV-2 infections and the manufacturer's data,
  • gloves may only be intended for healthcare personnel, including sanitation, services and other persons involved in efforts to control SARS-CoV-2 virus and the covid-19 disease caused by it and to avoid the further spread of the virus and the disease caused by it,
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.

Holler Box