Brexit And The Regulatory Question: Where Are We Now?
The UK needs the EU Medical Device Regulation. Logic dictates it and there are signs the country will adhere to these new upcoming rules – yet nothing is certain.
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The UK's departure from the EU will have a heavy impact on regulation of class III device/drug combinations. Will it mean more costs for industry, and more delays?
Will it be better to continue compliance under the Medical Devices Directive or switch to compliance under the new Medical Devices Regulation when there is a choice? The pros and cons make it a difficult decision.
The European Parliament is about to sign off corrigenda to the Medical Devices and IVD Regulations. The headline news is a longer transition period for a huge swathe of class I products, but there are other changes too.