Medtech companies that have been loyal to LRQA could find themselves at a serious competitive disadvantage as the organization pulls out as a notified body for medical devices and IVDs, putting the whole medtech regulatory system under increased stress.
UK notified body Lloyds Register (LRQA) has confirmed it is not only going to pull its application to become a notified body under the new Medical Device and IVD Regulations, but it is also withdrawing its services under the current Medical Device Directive and IVD Directive.
Medtech Insight has learned that clients have been given just 90 days’ notice and understands that LRQA has over 100...
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