Introduction
The Medical Devices Regulations 2002 (MDR 2002) has designated certain standards as technical specifications for medical devices and in vitro diagnostic (IVD) devices. The Medicines and Healthcare products Regulatory Agency (MHRA) is working to deliver a future regulatory framework for medical devices that prioritises patient and public safety, gives patients access to the medical devices they need, and ensures the UK remains an attractive market for medical technology innovators. The MHRA is seeking your valuable input through this survey on the prioritisation for designation of device standards that support compliance with the MDR 2002.
This survey will inform which standards the MHRA should prioritise for designation and covers:
- the standards designated that your organisation relies on
- the standards not designated that your organisation relies on and would most like to see designated