99 Days Until MDR: Time Is Running Out For Medtech As Risky, Volatile Future Looms
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.
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Following hot on the heels of its Rapidly Manufactured Ventilator Specification document, the UK’s regulator has issued another speedy regulatory permit for fast production of respiratory assist devices.
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