Slovenia Medical Device Registration

Comprehending the JAZMP’s Process and Requirements for Medical Device Registration and the Vigilant System

Medical Device Regulatory Authority

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP is the national competent authority of the Republic of Slovenia that assesses medicines and medical devices to determine whether they can be placed on the market, monitors the adverse reactions, and risks, and promotes the proper use of medicines and medical devices.

JAZMP provides expert advice based on an application by the applicant in relation to:

• 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

Link for Regulatory Authority

https://www.jazmp.si/en/medical-devices/

Local Regulation

Medical Devices Act, No. 98/09

The JAZMP maintains the Register of medical devices of manufactures, or their representatives established in the Republic of Slovenia, of devices in accordance with the Council Directive 93/42/EEC, Council Directive 90/385/EEC and the Directive 98/79/EC, and of devices in accordance with the Regulation (EU) 2017/745 – MDR and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.

Classification of Medical Devices 

Class I, lla, llb, III

Listing or Registration Requirements 

Must notify medical devices for entering the Slovenian Market: Manufacturers of medical devices with a registered office in the Republic of Slovenia, Authorized representatives of a manufacturer of medical devices with a registered office in the Republic of Slovenia. within 15 days. 

Documents Required for Slovenia Medical Device Registration

• EC declaration of conformity indicating that the test is intended for self-testing (risk class: IVD – self-testing, indicating the number of the CE certificate).
• CE certificate from a notified body established in the EU (with reference to Directive 98/79 / EC or Regulation (EU) 2017/746).
• Original instructions for use
• Instructions for use in the Slovenian language – please note that the translation must be the same as the original instructions with all references.
• To translate instructions into Slovenian, obtain written authorization from the manufacturer and send it to the Ministry of Health, ensuring they are informed of any changes or new editions. 

Registration Timeline

The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

License Validity

5 Years 

Registration Fees

The fees for the procedure related to registration in the register of medical devices are-

1. First Entry in the Register

• 1 to 10 claims: 40 points per claim – €200
• 11 to 20 claims: 35 points per claim – €175
• 21 to 30 claims: 30 points per claim – €150
• Over 31 claims: 25 points per claim – €125

2. Change data that do not affect the Entry

• 1 to 10 claims: 20 points per claim – €100
• 11 to 20 claims: 16 points per claim – €80
• 21 to 30 claims: 12 points per claim – €60
• Over 31 claims: 10 points per claim – €50

3. Change data affecting the Entry

• 1 to 10 claims: 30 points per claim – €150
• 11 to 20 claims: 25 points per claim – €125
• 21 to 30 claims: 20 points per claim – €100
• Over 31 claims: 15 points per claim – €75

The fees for classifying a product as a medical device – €950

The appointment fee on the day of the commission’s visit – €4550

Notification of Clinical Research

• Class I and IIa medical devices: 760 points – €3,800
• Class IIb, III, and active medical implants: 835 points – €4,175

Change in Clinical Research 

All classes of medical devices and implants: 380 points – €1,900

Note: All the prices mentioned above do not involve VAT.

Medical Device Vigilance

The medical device vigilance system aims to protect public health and patient safety by implementing corrective actions and reducing the likelihood of recurrence of past incidents. 

The JAZMP collects and evaluates serious incident reports in collaboration with medical device manufacturers or representatives, monitors their investigations, implements additional measures, and participates in the international medical device vigilance system. This system aims to reduce the risk of recurrence and ensure the safety of patients and users of medical devices.

What is an Incident?

Incident means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use error due to ergonomic characteristics, as well as any inadequacy in the information provided by the manufacturer and any undesirable side effect, and ‘serious incident’ means any incident that directly or indirectly leads to or might lead to:

the death of the patient, user, or other person;

the temporary or permanent serious deterioration in the state of health of the patient, user or other person;

What is a Serious Public Health Threat?

Serious public health threat means an incident that could result in an imminent risk of death, a serious deterioration in a person’s state of health, or a serious illness, which may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time. 

What are Field Safety Corrective Actions (FSCA)?

FSCA means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.

The manufacturer or the Authorised representative of the manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice.

The manufacturer or his authorized representative must also notify the JAZMP of any safety corrective action to be implemented in the territory of the Republic of Slovenia.

The manufacturer must ensure that users of the device concerned are informed without delay of the field safety corrective action taken. The FSCA shall be communicated to users in the form of a field safety notice. To inform users on the territory of the Republic of Slovenia, the field safety notice must be in Slovenian language.

Notification to JAMPA

Using Slovenian or English form for reporting the Field Safety Corrective Action:

• The manufacturer or his authorized representative must notify the JAZMP of any safety corrective action to be implemented in the territory of the Republic of Slovenia.
• The manufacturer registered in the Republic of Slovenia, or its authorized representative registered in the Republic of Slovenia must notify the JAZMP of any field safety corrective measure taken, even if the medical device concerned is not on the Slovenian market or the field safety corrective measure does not concern the Slovenian market. 

Additional Comments

On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

In accordance with the provisions of the Medical Products Act of the Republic of Slovenia, only Manufacturers of medical devices or Authorized representatives with a registered office in the Republic of Slovenia, must notify medical devices for entering into the register. 

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the Process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.u