Just Three UK Medical Device Notified Bodies Left As LRQA Pulls Out
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.
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'Burn Them Out, Turn Them Over': Add Auditor Exhaustion, 'Boutique' Approach To The List Of Notified Body Challenges
From not enough notified bodies and auditors, to a slew of new or updated international standards and regulations coming into force, the medtech industry is facing a number of NB challenges – and now they can add auditor burnout as a concern. "Because some of these notified bodies have such huge demand, they're burning people out really fast," industry expert Kim Trautman says, noting that device-makers can expect to see "boutique" notified bodies popping up over the coming decade. Also: Johnson & Johnson's regulatory director explains how the dearth of notified bodies and auditors is affecting the global medical products giant.
The UK is taking measures to increase its ventilator stock from 8,000 to some 30,000, but it will take time to make them available. Many are asking whether the government really rejected EU help, which could have brought relief sooner, because of Brexit.
How to get non-CE-marked medical devices onto the UK market at speed