UK Regulator Opens New "Office" for Innovative Medical Devices
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK medical device market regulator, has set up an “innovation office” in an effort to provide a more efficient market authorization process for manufacturers of cutting-edge products.
The new office—actually a web portal—is intended to assist manufacturers of novel medical technologies identify which UK or European regulations will apply to their devices. The MHRA believes that developers of Advanced Therapy Medical Products, nanotechnology and combination products will be able to more efficiently determine whether their devices will have to comply with CE Marking or other regulatory requirements using the agency’s new service.
Interested firms can submit confidential queries regarding their devices to MHRA via the innovation office portal at no charge; if the agency determines that a face-to-face meeting is necessary to determine regulatory requirements, fees may apply in such cases.