Manufacturer of custom-made devices means a natural or legal person who manufactures or fully refurbishes a custom-made device or has a custom-made device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
Custom-made device means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person are not considered to be custom-made devices.
- orthoses and prostheses,
- dental devices (including orthodontic braces, dental prosthesis/replacements, etc.),
- hearing aids and related devices,
- footwear,
- other medical devices.
According to the definition of a custom-made device and based on the EU harmonisation rules/guidance MDCG 2021-3: Questions and Answers on Custom-Made Devices, the vast majority of opticians and ophthalmic clinics are not classified as manufacturers. Instead, they are regarded as distributors or importers of those devices if they make such devices available, even if they adapt or prepare them slightly for the end user.
Activities according to Standard Classification of Activities (SCD):
C32.500 – Manufacture of medical and dental instruments and supplies
Registration with the JAZMP
Manufacturers of custom-made devices established in the Republic of Slovenia must register with the JAZMP information system before commencing their activities.
An application for the registration of a manufacturer of a custom-made devices must contain the following:
- Registration form: Form 856-02
Mandatory attachments
- 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.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC are not required to have the 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.
Manufacturers of custom-made devices must confirm the accuracy of their registration data annually, based on a request issued within the JAZMP information system. This confirmation must be carried out by the deadline specified in the request, which must be at least 30 days long. If they fail to do so, the JAZMP will initiate the procedure for deletion from the register 30 days after the deadline for confirming data accuracy has expired.
Change of economic operator data
Manufacturers of custom-made devices established in the Republic of Slovenia must notify the JAZMP of any changes to their data by submitting a new application – Form 856-02 no later than eight days after the change is made.
Deletion of economic operator
Manufacturers of custom-made devices established in the Republic of Slovenia must notify the JAZMP of the cessation of placing these devices on the Slovenian market by submitting a new application no later than eight days after the cessation of the activity.
- Deletion form: Form 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.
