ARTICLE SUMMARY:
Urgency is building to get the minimum pieces into place to support May 2022 implementation of the EU IVD Regulation.
A report out June 7 from the EU Medical Device Coordination Group. The “Joint Implementation and Preparedness Plan” warned of the risk of losing access to some critical diagnostics without coordinated efforts to ensure that the EU, notified bodies, and manufacturers are able to operate under the new regulation in time. MDCG identified three overall essential areas that should take first priority in the short term:
- Contingency planning, including market and capacity monitoring, as well as running scenarios, such as the prospect of implementing IVDR during a health crisis if COVID-19 spikes again next May.
- Kicking efforts into a higher gear to designate more notified bodies under the IVDR. There are currently four IVDR notified bodies. But, MDCG acknowledges, “in the absence of information on the numbers of certifications needed, it is…not possible to predict what capacity of notified bodies will be sufficient to satisfy the demand.”
- Accelerating efforts to stand up EU reference laboratories, which are required in the IVDR to help ensure consistent assessment of high-risk Class D devices.
The next level down of “high priority,” but not essential, actions identified by MDCG include finalizing more Common Specifications (specific, legally binding requirements for certain IVDs); initiating the IVD Expert Panel to assess certain Class D devices; pushing forward on efforts to harmonize standards; and issuing more guidance on notified body topics, performance evaluations, companion diagnostics, and in-house lab tests. “It should be recognized that focusing on a specific set of jointly agreed priorities could temporarily result in less resources being invested into other areas,” MDCG writes.
Excerpted from “Pathways' Picks June 9: China AI Guide, IVDR Plan, and More To Watch,” Market Pathways, June 9, 2021.
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