legal aid in the market introduction of protection measures against Covid – 19 – email@example.com
S Category: personal protective equipment
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
- carrying out the conformity assessment procedure in accordance with Regulation 2016/425 on personal protective equipment,
- the preparation by the manufacturer of a declaration of conformity with the requirements of Regulation 2016/425 on personal protective equipment, a model declaration is available below:
EU DECLARATION OF CONFORMITY
- PPE (product number, type, batch or serial number):
- Name and address of the manufacturer and, where applicable, of his authorized representative:
- This declaration of conformity shall be issued under the sole responsibility of the manufacturer:
- Subject of the declaration (identification of PPE enabling traceability; a sufficiently clear colour illustration may be included where this is necessary for the identification of PPE):
- The subject matter of this declaration described in point 4 shall comply with the relevant requirements of Union harmonisation legislation: …
- References to the relevant harmonised standards which have been applied, together with the date of the standard, or to other technical specifications, together with the date of the specifications for which conformity is declared:
- Where applicable, the notified body … (name, number) … carried out an EU type-examination (Module B) and issued an EU type-examination certificate … (reference to this certificate).
- Where appropriate, PPE shall be subject to a conformity assessment procedure … (either type compliance based on internal production control and supervised product inspections at random intervals (module C 2) or type conformity based on production process quality assurance (module D)) … under the supervision of the notifier … (name, number).
- Additional information:
Signed on behalf of: …
(place and date of issue):
(name, position) (signature):
- obtaining a certificate issued by a European notified body which confirms that the product complies with the standard required for it (the list of certification bodies is available here: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501);
Note! Many products with incorrect certificates have appeared on the market, for example, the certificate was issued by an unauthorized entity; it is therefore important to check that you have the correct certificate,
- ce marking of the product.
These products – as individual protection measures – should comply with the requirements of the standard:
- PN-EN 167:2005 – Personal eye protection — Optical test methods (or EN 167:2001, respectively);
- PN-EN 168:2005 – Personal eye protection — Non-optic test methods (or EN 168:2001, respectively).
- declaration of conformity for compliance with the requirements of Regulation 2016/425 on personal protective equipment,
- a certificate for the product confirming that the product complies with the required standard.
- CE marking,
- the name of the type, batch or batch number or other information enabling the measure to be identified (where the size or nature of the product does not allow it— the required information shall be included on the packaging or in the accompanying document),
- the manufacturer's details, i.e. the name, registered trade name or registered trade mark and the postal address at which it can be contacted (if it is not possible to affix to the product , the manufacturer's details shall be indicated on the packaging or in the accompanying document)
- the importer's data – in the case of imported protection measures – i.e. the name, registered trade name or registered trade mark and the postal address at which it can be contacted (if it is not possible to appear on the product – the importer's data shall be indicated on the packaging or in the accompanying document).
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 before the conformity assessment is completed and without the CE marking,
- however, the product must comply with the guidelines of the national consultant,
- on the packaging must be atoned:
- information that the product may only be used during an increased epidemic and epidemic period, but not more than 30 days after the end of the epidemic in relation to SARS-CoV-2 infections, and
- manufacturer's details (name and address),
- these products may only be intended for staff providing health care services, including sanitation, services and other persons involved in action against the coronavirus epidemic.
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.
In accordance with the provisions of the Regulation of the Minister of Finance of 25 March 2020. on goods and services for which the rate of tax on goods and services is reduced and the conditions for the application of reduced rates, it is possible to apply a reduced rate of 0% of the tax in the case of the free transfer by a taxable person of goods belonging to his undertaking, in particular any donations of personal protective equipment – only masks, face guards/windows, goggles, safety goggles, overalls, shoe protectors, caps and gloves.
However, certain conditions must be met for the application of the reduced VAT rate (the donation must be made in writing, between the donor and one of the entities enumerated in the legislation, it must be clear from the contract that the goods delivered will be used by the rightholders).
The reduced rate of VAT can therefore be applied to donations made under the above conditions between 1 February 2020 and 31 August 2020.