Medical devices are classified according to the level of risk to the user, how and where the device will be used, whether it depends on a power source, how long it will be used and other characteristics.
- Class I – low risk;
- Class IIa – medium risk;
- Class IIb – high risk; and
- Class III – highest risk.
Based on where and how the devices will be used, they are divided into invasive and non-invasive medical devices, and based on whether or not the device depends on a power source, it is classified as either an active or passive medical device.
- medical devices in List A of Annex II to Directive 98/79/EC;
- medical devices in List B of Annex II to Directive 98/79/EC;
- in vitro diagnostic medical devices for self-testing not included in lists A or B; and
- all other in vitro diagnostic medical devices.
As of 26 May 2021, the placing on the market, making available on the market or putting into service medical devices, their accessories and products without an intended medical purpose listed in Annex XVI of the Regulation (EU) 2017/745 became subject to the Regulation (EU) 2017/745 on medical devices.
In vitro diagnostic medical devices are also medical devices. They are still regulated in their entirety by the Medical Devices Act [Official Gazette of the Republic of Slovenia], No. 98/09), while the European regulation for this area, i.e. Regulation (EU) 2017/746 on in vitro diagnostic medical devices, will apply from 26 May 2022.
- Class A – the lowest level of risk to the user;
- Class B;
- Class C;
- Class D – the highest level of risk to the user.
Most devices in higher risk classes (Class B, C and D) compliant with Regulation (EU) 2017/746 will, under the new legislation, require the involvement of a notified body in the conformity assessment and the obtaining of an EU certificate.
As the competent authority for medical devices, the JAZMP also provides expert advice in the field of medical devices on the basis of Article 12 of the Medical Devices Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 98/09) on expert advice.
PROVISION OF EXPERT ADVICE
- the translation of the instructions for use and labelling of medical devices;
- the differentiation between medical devices and other products;
- the classification of medical devices.
- applicant details;
- manufacturer details;
- details of the manufacturer’s legal representative if the manufacturer is not established in the EU;
- details of the authorised representative of the manufacturer or the legal representative (if applicable);
- product name;
- product description (composition);
- main function of the product;
- intended use of the product;
- instructions for use of the product;
- promotional material for the product.
It is recommended to enclose as much of the promotional material with the application as possible (advertising material, proposed wrapping or outer packaging, etc.). Ensure that the application is in the form of a letter written in Slovenian and enclose the instructions for use of the device in Slovenian or English. If the promotional material for the product is only available in English, please enclose it with the application – there is no need to provide a Slovenian translation.
The written application may be submitted by the manufacturer of the product, by the manufacturer’s legal representative if the manufacturer is not established in the EU, or by the authorised representative of the manufacturer or the legal representative if the applicant is not the manufacturer of the product. Please note that the application must be accompanied by the relevant authorisations.
On the basis of the application, the JAZMP will issue an opinion on whether the product should be classified as a medical device.
- the applicable legislation, i.e. the classification rules for medical devices set out in Annex VIII to Regulation (EU) 2017/745 on medical devices;
- the rules for in vitro diagnostic medical devices set out in Annex II to Directive 98/79/EC on in vitro diagnostic medical devices;
- the applicable guidance available on the European Commission’s webpage on Guidance – MDCG endorsed documents and other guidance;
- Guidance MEDDEVs
- other scientific literature in the field to which the product that is the subject of the classification advice belongs.
COSTS OF PROCEDURE
- for expert advice relating to the translation of instructions for use and labelling of a medical device (1,500 characters per page, without spaces) – 50 points;
- for expert advice relating to the differentiation between medical devices and other products – 200 points;
- for expert advice relating to the appropriate classification of medical devices – 250 points.
The fees are specified in points. The value of one point is EUR 5 excluding value added tax (VAT). The amount of the fee is the point value multiplied by the number of points.
The applicant pays the fee after receiving the notice of due payment or the notification on the payment method from the JAZMP.
The JAZMP sends a notification on the payment method to the email address indicated by the applicant in the application form. The applicant must pay the fee within 15 days to the sub-account of the JAZMP.