In Vitro Diagnostic Medical Device Regulation (IVDR)

In Vitro Diagnostic Medical Device Regulation (IVDR)

The acronym IVDR stands for In Vitro Diagnostic Medical Device Regulation and it entered into force on May 26, 2017 to replace the In Vitro Diagnostic Directive 98/79 / EC (IVDD).
Regulation (EU) 2024/1860 extend further the transitional periods laid down in Regulation (EU) 2017/746 for devices covered by certificates issued by notified bodies in accordance with Directive 98/79/EC and for devices which are to undergo conformity assessment involving a notified body for the first time under Regulation (EU) 2017/746.

The following paragraphs are inserted:

3a. Devices which have a certificate that was issued in accordance with Directive 98/79/EC and that is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until 31 December 2027

3b. Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates:

(a) 31 December 2027, for class D devices;

(b) 31 December 2028, for class C devices;

(c) 31 December 2029, for class B devices and for class A devices placed on the market in sterile condition

You can find the official document of the Regulation (EU) 2024/1860 here: Regulation – EU – 2024/1860 – EN – EUR-Lex

Eureka Lab Division as a manufacturer of class B and C IVD devices undertakes:
– to maintain high quality products and to satisfy all market needs;
– to face the transition to the new requirements set by the IVDR 2017/746 issued by the European Commission in the times and methods established by the EU regulation 2017/746 and by Regulation (EU) 2024/1860.

The purpose of the new regulation

The IVDR arises from the need to increase safety and efficiency in the EU medical device market.

Our aim

Eureka Lab Division is committed to producing excellent and highly competitive IVDR compliant products that meet the requirements of the European market to offer ever greater safety to all customers.

Chiaravalle, 04.04.25