by Dr. Mario Koksch, Vice President and General Manager, Flow Cytometry Business Unit at Beckman Coulter Life Sciences
The marathon for IVDR compliance has added a few more laps beyond the May deadline, but the earlier labs prepare the better. While the In-Vitro Diagnostics Regulation (IVDR) will raise the standards of in vitro diagnostics, it is also expected to complicate compliance not only for manufacturers but also for laboratories. In fact, many laboratories have not achieved IVDR compliance over the past five years to meet plans established in 2017.1 While many were involved in the battle against COVID-19, others were not aware of the repercussions of the new Laboratory Developed Test (LDT) regulations.
The initial May 2022 deadline has been extended, but that does not relieve manufacturers and laboratories of the responsibility to undertake critical tasks ahead. On the contrary, affected organizations must see this as an opportunity to take immediate action to add to their competitiveness and credibility when the regulations will be in full effect. Thus, they will reestablish their top spots in the new era of high-quality IVD supply in Europe.
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