General

Medical devices are classified on the basis of the level of risk for the user, the location and method of use, dependence on the power source, useful life and other characteristics. With respect to the level of risk for the user, they are divided into the following classes:

  • class I – low risk
  • class IIa – medium risk
  • class IIb – high risk, and
  • class III – the highest level of risk

With respect to the site and method of use, they are divided into invasive and non-invasive medical devices, and with regard to their dependence on the power source into active and passive medical devices.
In vitro diagnostic medicinal devices are classified on the basis of the level of risk:

  • list A,
  • list B,
  • medical devices for self-testing not included in List A or List B, andall other in vitro diagnostic medicinal devices.

Medical devices are classified on the basis of the classification rules laid down in Annex IX to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and on the basis of the rules for in vitro diagnostic medical devices laid down in Annex II to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.

Expert advice procedure

On the basis of the application of the applicant, JAZMP offers:

  • Expert advice regarding translation of the instructions for use and labelling of medical devices;
  • Expert advice relating to the borderline between medical devices and other products
  • Expert advice relating to classification of medical devices into appropriate class.

In case of doubt as to the classification of medical devices, JAZMP provides expert advice regarding classification. Professional expertise is provided on the basis of the client’s written application, which should include the following documentation:

  • applicant’s details,
  • product name,
  • product description (composition),
  • product’s main purpose of operation,
  • product’s purpose of use,
  • instructions for use of the product,
  • product promotion material, and
  • proof of fee remittance.

Costs of te procedure

The fees for expert advice regarding medical device classification are set out in Article 5 of the Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No 37/10) as follows:

  • for expert advice relating to translation of instructions for use and labelling of a medical device (1500 characters per page, without spaces) – 30 points;
  • for expert advice relating to the distinction between medical devices and other products – 150 points;
  • for expert advice relating to placing medical devices in the appropriate class – 200 points;

The fees are specified in points. The point value is EUR 5. The amount of the fee is the point value multiplied by the number of points.

Costs of the procedure

The fees for expert advice regarding medical device classification are set out in Article 5 of the Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No 37/10) as follows:

  • for expert advice relating to translation of instructions for use and labelling of a medical device (1500 characters per page, without spaces) – 30 points;
  • for expert advice relating to the distinction between medical devices and other products – 150 points;
  • for expert advice relating to placing medical devices in the appropriate class – 200 points;

The fees are specified in points. The point value is EUR 5. The amount of the fee is the point value multiplied by the number of points.

After reviewing the application, JAZMP sends a notice on the payment of a fee to the applicant with all information required for payment.