Device to rescue babies in emergency situations due to fire, chemical and gas contamination, or natural catastrophes
Question
We would appreciate your support regarding country-specific requirements and regulations for CE registration, as our product called Lifebox does not fall under any specific product group or industry definition within EU legislation, as stated on the EU regulatory legislation website.
As a start-up company, our goal is to apply a CE mark (in accordance with EU DIRECTIVE 2001/95/EC) to our product Lifebox and launch it EU-wide. The purpose of Lifebox is to rescue babies in emergency situations and transport them to a safe area. It is important to note that Lifebox does not have a diagnostic or therapeutic intended use like a medical device, nor is it intended for personal use by rescue personnel.
Considering the unique nature of Lifebox, we have the following questions regarding CE registration:
Based on the intended use of Lifebox, are there any country-specific requirements, directives, or guidelines for the CE mark that we should comply with in addition to EU DIRECTIVE 2001/95/EC? We would appreciate references and/or web links to this information.
Based on the intended use of Lifebox, is there a country-specific process or contact address for CE mark registration (based on EU DIRECTIVE 2001/95/EC)? Please provide us with the relevant information and/or web links.
Answer
Having regard to your query in the matter of specific requirements and regulations for CE marking in Slovakia, the Consumer Protection Department of the Ministry of Economy of the Slovak Republic provides you with the following information.
In the matter of product safety, product safety requirements are set out in the Directive 2001/95/EC of the European Parliament and of the Council on general product safety (“Directive”) as well as in the specific Community harmonized legislation (“harmonized legislation”). Directive, on the one hand, determines the general product safety requirements and is applicable for all the products which do not fall under the harmonized legislation. The harmonized legislation, on the other hand, determines safety requirements of specific products (such as toys, personal protective equipment or medical devices), whose nature requires stricter approach to the safety requirements than is determined in the Directive.
Most of the EU regulations and directives which are part of the harmonized legislation determine the obligation to affix the CE marking to the product. General principles of CE marking are set out in the Regulation No. 765/2008 of the European Parliament and of the Council on setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (“Regulation”). The Article 30 of the Regulation states: “The CE marking as presented in Annex II shall be affixed only to the products to which its affixing is provided for by specific Community harmonization legislation, and shall not be affixed to any other product. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonization legislation providing for its affixing.”
Following the above, in case product does not fall under any harmonized legislation but is governed by the Directive, it must not bear the CE marking. However, it is important to keep in mind that even though the product does not fall under the harmonized legislation and does not have to bear the CE marking, the producer still has to be able to prove that the product meets the general product safety requirements. In this context, the Directive determines what elements may be taken into account when assessing the conformity of a product to the general safety requirement. These elements are for instance voluntary national standards transposing relevant European standards, Commission recommendations setting guidelines on product safety assessment or product safety codes of good practice in force in the sector concerned. However, in practice, the most common way to ensure the product safety is to comply with the technical standards. In this regard, it is also important to point out that the principle of mutual recognition is applicable within in EU market. According to this principle, EU member states may not prohibit the sale of goods that have been lawfully marketed in another member state even if those goods have been produced in accordance with different technical rules.
As regards the product safety requirements within the Slovak legislation, there are no country-specific requirements, directives or guidelines for general product safety in addition to the Directive. General product safety requirements are determined in Section 6 of the Act No. 250/2007 Coll. On Consumer Protection, available on https://www.mhsr.sk/obchod/ochrana-spotrebitela/legislativa-v-oblasti-ochrany-spotrebitela-v-anglickom-jazyku and in the Government Order of the Slovak Republic No. 404/2007 Coll. available on https://www.slov-lex.sk/pravne-predpisy/SK/ZZ/2007/404/20070901 (unfortunately not available in English version). These two legal acts implement the provisions of Directive and represent the legal framework of general product safety in Slovakia.
According to your statement, product Lifebox developed by your company has no diagnostic, therapeutic or personal use and is only used to rescue babies in emergency and transport them to the safe area. Based on the above, if you are sure, that this product does not fall under any harmonized legislation but the Directive, it must not bear the CE marking. As regards to specific safety requirements applicable in Slovakia, there are no additional requirements or directives and general safety requirements set out in the Directive are applicable.
I hope the above information was helpful. Should you have any questions, please, do not hesitate to contact us.