Norway’s DNL GL Presafe Listed As 10th Notified Body Under EU MDR
With just three months and three weeks until the full application of the EU Medical Device Regulation (MDR) on 26 May this year, a tenth notified body has been designated under the regulation.
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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