There are various products available on the market, whose classification among medical devices is dubious, because their distinction from medicinal products, personal protective equipment, biocides, cosmetics etc. is not clear.
Pursuant to Article 15 of the Medical Devices Act (Official Gazette of the Republic of Slovenia, No 98/09), for the above-mentioned products it is necessary to take account of the main purpose of their operation. A product may be classified as a medical device if – in terms of its properties and the main purpose of its operation – it corresponds to the definition of a medical device referred to in Articles 3 to 8 of the Act. If a medical device has been put on the market solely for the purpose of using a medicinal product, it is subject to the provisions of the above Act.
Medical devices that are put on the market to be combined with a medicinal product to form a single integral product, intended exclusively for use in the given combination and not to be re-used are subject to the provisions of the act regulating medicinal products. The characteristics of the medical device related to its safety and performance must correspond to the essential requirements of the Act. Where a medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of the provisions on medicinal products, and which is liable to act upon the body with action ancillary to that of the medical device, that product is considered to be a medical device. Where a medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of the provisions regulating medicinal products, and which is liable to act upon the human body with action that is ancillary to that of the device, that device is considered to be a medical device. Medical devices intended to be used as personal protection equipment in accordance with the provisions on personal protection equipment must meet the appropriate requirements for safety and health, in line with the provisions on personal protective equipment.
For classifying a product, the guidelines of the European Commission “Borderline products, drug-delivery products and medicinal devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative” may be used MEDDEV 2.1/3.
The procedure of classification of a product as a medical device
In case of doubt regarding the classification of a product as a medicinal device, the applicant may submit an application for the classification of a product in writing or in electronic form, signed with a secure electronic signature with a digital certificate, on the form MedPri-MP-obr01, enclosing the following documentation:
- instructions for use of the product
- promotional material of the product
We recommend you to enclose as much of the promotional material as possible (advertising, mock-up of wrapping or outer packaging etc.).Based on the application of the applicant, JAZMP issues a decision in which they determine whether the product is classified as a medicinal device.
Based on the application of the proposer, JAZMP issues a decision whether the product is classified as a medicinal device.
Costs of the procedure
Costs of the procedure for classifying the product as a medical device are defined in Article 5 of the Rules relating to fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No. 24/19)
· the fee for the classification of a product among medical devices is 190 points.
The fees are specified in points. Value of one point is 5 EUR excluding tax. The amount of the fee is the point value multiplied by the number of points.
The applicant pays the fee upon the receipt of the JAZMP’s call for payment or notification from JAZMP regarding payment of the fee.
JAZMP sends a notification regarding payment of the fee to the e-mail address of the applicant. The applicant pays the procedure fee within 15 days to the JAZMP account.