IVDR

IVDR readiness statement

05.07.2021

The new In-Vitro Diagnostic Regulation (2017/746/EU) replaces the current In-Vitro Diagnostic Directive (IVDD 98/79/ec) after a five-year transitional period, which ends on 26 May 2022.
It provides the regulatory framework for safe and effective tests for the benefit of patients.
We have long been determined to ensure the present and future availability of our products under the new European medical device rules. Our intention is to fulfil IVDR requirements for our IVD products until the end of the transition period, to meet the needs of our customers by ensuring the continuous supply of essential, system-relevant in-vitro diagnostic medical devices.

Compliance

Immundiagnostik has established the project “Compliance with IVDR and Assurance of marketability from May 2022” and defined the necessary resources. As a result of a comprehensive compliance analysis Immundiagnostik has developed a series of measures to achieve IVDR readiness. The Immundiagnostik implementation strategy includes:

  • Verified assessment of the entire product range based on the new risk-based classification system
  • Initialization of the consequent modified conformity assessment procedures
  • Selection of IVDR designated notified body
  • Amplification of competence and the expansion of state-of-the-art production capacities
  • Implementation of the required adjustments to the Quality Management System
  • Re-Compilation of technical documentations to maintain valid Declarations of Conformity under the IVDR

Turbulent times caused by the COVID-19 situation and a not fully settled regulatory environment (e.g. lack of technical solutions to implement IVDR such as EUDAMED, EU reference laboratories, designated notified bodies etc.), make the IVDR transition challenging and bear the risks of supply delays. Immundiagnostik meets these challenges and continues to follow the action plan laid out in our IVDR implementation strategy by providing the required resources to secure a timely transition from IVDD to IVDR.

Questions? Please contact IVDR.

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