The European Commission’s Medical Device Coordinating Group (MDCG) has updated its priorities regarding the In Vitro Diagnostic Medical Devices Regulation (IVDR).
The MDCG updated its Joint implementation and preparedness plan for the IVDR to reflect ongoing progress of its work and to set new priorities for the European Regulation (EU) 2017/746 (IVDR).
IVDR plan organization
The 20-page document provides a legislative update on the current status of the IVDR and continues with prioritization of the required strategic actions and guidance to overcome current challenges and to establish an operational system in the EU. The plan is divided into three sections and an annex.
The first section (I. Introduction) includes the legislative background to the IVDR and summarizes the changes and amendments introduced since the planned transition to the Regulation in 2017. Examples of accomplishments to date are included.
Section two (II. Priority areas and actions) describes the concrete actions that enable contingency planning, as well as those on the vital infrastructure of the EU IVD sector. The priority areas are divided into two sets, Set A and Set B, with Set A categorized as essential actions (short-term priorities), and Set B for actions on legislation and guidance documents which should ease the work of affected stakeholders; A separate focus is given to the designation of EU reference labs for high-risk IVDs.
Section three is a brief conclusion section titled “Beyond May 26, 2022, the IVDR’s date of application.”
The Annex table (Summary of actions) repeats each priority action and shares the timeline and status.
MDCG Updates Joint Implementation Plan for European IVDR | UL Solutions (emergobyul.com)
MDCG Updates Joint Implementation Plan for European IVDR
IVD manufacturers doing business in Europe will want to review regulators’ current list of priorities to maintain market access.
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