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).
EU Regulation 2022/112 has extended the transitional periods for current IVDD products as specifically reported in the article 1.1b which states:
Devices for which the conformity assessment procedure pursuant to directive 98/79 / EC did not require the intervention of a notified body, for which a declaration of conformity was drawn up before 26 May 2022 pursuant to this directive and for which the conformity assessment procedure under this Regulation requires the intervention of a notified body, may be placed on the market or put into service until the following dates:
a) May 26, 2025 for class D devices;
b) May 26, 2026 for class C devices;
c) May 26, 2027 for class B devices;
d) May 26, 2027 for class A devices placed on the market under sterile conditions.
You can find the official document of the EU Regulation 2022/112 here:
https://eur-lex.europa.eu/eli/reg/2022/112/oj
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 the EU regulation 2022/112

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, rev. 0 of 04.04.22