Systems or procedure packs as provided in Article 22 of Regulation 2017/745/EU – devices bearing a CE marking are combined with other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers.
Procedure pack means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.
System means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose.
Activities according to Standard Classification of Activities (SCD):
C32.500 – Manufacture of medical and dental instruments and supplies
Registration with the JAZMP
Until EUDAMED is fully functional, natural or legal person combining systems and procedure packs in accordance with Article 22 of Regulation 2017/745/EU established in the Republic of Slovenia must register with the JAZMP before commencing their activities on the Slovenian market.
Applications for registration must include the following:
- Registration form: Obr. 862-01
- Mandatory attachments:
⇒ Statement in which the natural or legal person combining systems and procedure packs in accordance with Article 22 of Regulation 2017/745/EU established in the Republic of Slovenia declares that:
- they verified the mutual compatibility of the devices and other products, in accordance with the manufacturers’ instructions and have carried out their activities in accordance with those instructions;
- they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;
- the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.
⇒ Documentation demonstrating the appropriate qualifications of the person who is responsible for regulatory compliance in accordance with Article 15 of Regulation 2017/745/EU. The required expertise must be demonstrated by holding one of the following qualifications:
- A diploma, certificate or other evidence of formal qualification, awarded upon completion of a university degree or a study programme recognised by the Member State concerned as equivalent in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Micro and small enterprises, within the meaning of Commission Recommendation 2003/361/EC, are not required to have a person responsible for regulatory compliance within their organisation. However, such a person must be permanently and continuously at their disposal.
The completed, signed and stamped form, together with the mandatory attachments, must be submitted to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana, either by ordinary post or in person during office hours.
Upon receiving a complete application (including the form and all mandatory attachments), the JAZMP will process it. The applicant will receive a digitally signed Certificate of Registration of the Economic Operator via the company’s general email address.
CHANGE OF ECONOMIC OPERATOR DATA
Natural or legal person combining systems and procedure packs in accordance with Article 22 of Regulation 2017/745/EU and established in the Republic of Slovenia must notify the JAZMP of any changes to their data by submitting a new application (Obr. 862-01) no later than eight days after the change is made.
DELETION OF ECONOMIC OPERATOR
Natural or legal person combining systems and procedure packs in accordance with Article 22 of Regulation 2017/745/EU established in the Republic of Slovenia notify JAZMP of the cessation of placing on the market no later than eight days after the cessation by submitting the following application:
Deletion form: Obr. 861-03
The completed, signed, and stamped form must be submitted to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana, either by ordinary post or in person during office hours.
Registration in EUDAMED
Persons from Article 22 of Regulation (EU) 2017/745 combining systems and procedure packs must register with the European Database on Medical Devices (EUDAMED) to obtain a Single Registration Number (SRN).
- Electronic application: Registration in EUDAMED (Actors Module)
The JAZMP only assigns an SRN to operators who attach the following to Step 5 of the EUDAMED registration:
- A digitally signed declaration: Declaration on Information Security Responsibilities (in PDF format) signed with a qualified digital certificate (SIGEN-CA, SI-PASS, Pošta®CA, AC NLB, or Halcom CA).
If the declaration is hand-signed, the original physical document must be sent to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana.
Medical Device Registration
Instructions on registration of medical devices are published here: Registration of medical devices – JAZMP.
REGISTER
Register of Systems and procedure packs producers from Article 22 of Regulation (EU) 2017/745
