June 16, 2021
The European Commission (EC) published the Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) this month, laying out tasks that need to be accomplished before the EU In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) goes into effect and identifying the parties responsible for them.
EC maintains May 2022 Date of Application for IVDR despite calls for delay
The joint implementation plan was released following a May 28 meeting of the Medical Device Coordination Group (MDCG), which reviewed and endorsed its contents. It cites stakeholder input, although some industry voices have been vocal about concerns that a May 2022 Date of Application (DoA) is unfeasible, especially given the disruption caused by the COVID-19 pandemic. Two days prior to the MDCG meeting, a joint stakeholder letter and press release appeared calling on the EC to postpone the DoA for one year and subsequently use a phased implementation approach.
The approach of the joint implementation plan is to acknowledge the great amount of work remaining to be done before the IVDR DoA, establishing a timetable and identifying responsible parties so that the remaining year can be spent productively. The plan focuses on prioritizing ongoing work items or actions vital for the implementation of the IVDR into two sets: Set A includes essential actions necessary for market access, while Set B includes high-priority actions that would greatly facilitate the work of stakeholders.
EU IVDR joint implementation plan divides tasks into two priority levels
Set A outlines the following essential actions that must be completed prior to IVDR implementation:
- Contingency planning and monitoring – Discussion needs to occur about how to prevent and respond to shortages of critical IVDs in the event of a health crisis, a risk highlighted by experiences of the COVID-19 pandemic.
- Addressing Notified Body availability – EU Member States must provide experts to conduct joint assessments of Notified Bodies (NBs) in order to expedite designation under the IVDR, while currently designated NBs need help performing conformity assessment activities under pandemic conditions. The issue of Notified Body capacity has been a key concern, given that the IVDR will vastly increase the percentage of IVDs in Europe requiring NB intervention from around 10% to an estimated 80-90%.
- Designating EU Reference Laboratories – There are multiple steps needed, including adopting implementing acts and carrying out a survey on required capacity, to complete the process of designating EU Reference Laboratories under the IVDR. These institutions are new to the field of IVD regulation and will be used for the assessment of some high-risk class D devices.
Set B includes the following high-priority actions, which are not absolutely essential but desirable to complete before the IVDR DoA:
- Adopting common specifications (CS)
- Publishing guidance for NBs specific to the IVD sector
- Providing guidance on performance evaluation and clarifying the process for NBs to work with expert panels, as required for some novel high-risk IVDs
- Developing and approving a template for the summary of safety and performance, a new document required for class C and D IVDs under the IVDR
- Proceeding with work on MDR/IVDR harmonized standards
- Completing guidance on companion diagnostics
- Completing guidance on in-house devices, which were increasingly used during the pandemic and will be more strictly regulated under the IVDR
An annex to the plan contains a table summarizing all actions that must be completed by the IVDR Date of Application, with the target deadline and status of each.