Registration of in vitro diagnostic medical devices in accordance with the Directive 98/79/EC and according to the transitional provisions of the regulation (EU) 2017/746 (IVDR)

In accordance with Article 110 of the IVDR (transitional provisions) and Regulation (EU) 2022/112 (amendment of the transitional provisions of the IVDR, in vitro diagnostic medical devices of class B, C and D compliant with Directive 98/79/EC may be placed on the market after the date of application of the IVDR, insofar as the design and intended purpose have not changed significantly, under the following conditions:

  1. with certificates issued according to the Directive 98/79/EC before 25 May 2017 until the certificate expires:
    • certificates remain valid until the date on the certificate;

    • certificates issued in accordance with Annex VI to Directive 98/79/EC are valid until 27 May 2025 at the latest.

  2. with certificates issued according to Directive 98/79/EC after 25 May 2017 until the certificate expires:

    • certificates become invalid no later than 27.5.2025.

  3. if after 26.05.2022 they comply with Directive 98/79/EC and the design and intended purpose have not changed significantly, they may be placed on the market or put into service:

    • if they have a valid certificate issued in accordance with Directive 98/79/EC until 26 May 2025.

  4. If they comply with Directive 98/79/EC after 26/05/2022, if the design and intended purpose have not changed significantly, and for specific in vitro diagnostic medical devices according to Directive 98/79/EC:
    • it was not necessary to include a notified body when determining compliance (devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body);
    • the declaration of conformity was drawn up prior to 26 May 2022 and
    • for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body (in accordance with the IVDR, they are classified in class B, C, D or A-sterile IVD MP), may be placed on the market or put into service until the following dates:
      • 26 May 2025, for class D devices (available on the market or put into service until: 26.5.2026)
      • 26 May 2026, for class C devices (available on the market or put into service until: 26.5.2027)
      • 26 May 2027, for class B devices (available on the market or put into service until: 26.5.2028)
      • 26 May 2027, for class A devices placed on the market in sterile condition (available on the market or put into service until: 26.5.2028).

The requirements of the IVDR relating to post-market surveillance, market surveillance, vigilance and registration of economic operators shall apply in accordance with the IVDR.

Exception: From May 26 2022, class A devices can only be placed on the market in accordance with the IVDR.

To register in vitro diagnostic medical devices, complete the following forms:
  • Annex A (for initial registration)
  • Annex B (for a change of data not affecting the changes to the entry in the register, e.g. instruction manual)
  • Annex C (to change the data affecting the changes of the entry in the register – EC Declaration of Conformity, EC Certificate, cessation of production)
COSTS OF PROCEDURE

The costs of procedure for entry in the Register of medical devices are specified in Article 8 of the Rules on fees in the field of medical devices (Uradni list RS, No.24/19).

Fees for the procedure relating to entry into the Register of medical devices:

for initial registration:
  • 40 points per request (1 to 10 requests per application);
  • 35 points per request (11 to 20 requests per application);
  • 30 points per request (21 to 30 requests per application);
  • 25 points per request (over 31 requests per application to a maximum of 2,000 points);
for a change of data not affecting the entry in the register:
  • 20 points per request (1 to 10 requests per application);
  • 16 points per request (11 to 20 requests per application);
  • 12 points per request (21 to 30 requests per application);
  • 10 points per request (over 31 requests per application to a maximum of 800 points);
for a change of data affecting the changes of the entry in the register:
  • 30 points per request (1 to 10 requests per application);
  • 25 points per request (11 to 20 requests per application);
  • 20 points per request (21 to 30 requests per application);
  • 15 points per request (over 31 requests per application to a maximum of 1,200 points).
NOTE: 

Each request means a model of the medical device for which a decision is issued.

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 by 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.

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