UK Responsible Person
IVDeology are a UK based company with the experience and capability to act as a UKRP for IVD manufacturers, we will work with you to place your products on market and get you ready to meet the requirements of the UKCA mark from 2023.
Why Do You Need It?
To register the device with the MHRA and support the manufacturer in post-market surveillance activities, including communication with the MHRA and UK customers and importers.
Why appoint IVDeology as the UKRP for your product?
- Experience working with the Medicines and Healthcare Products Regulatory Agency (MHRA) and will register the device, provide responses and communicate on your behalf
- Reviewing the technical documentation, declaration of conformity and CE certificates
- Report complaints and incidents to the manufacturer
- Complaint and Incident reporting to the manufacturer
With IVDeology as your UK Responsible Person we will:
- Register devices with MHRA
- Prepare technical documentation
- Communicate with the MHRA on your behalf
- Ensure technical documents are inspection ready
- Complaint and incident reporting to the manufacturer