MHRA UK Medical Device Registration & Approval
With a population nearing 68 million and ranking as the third-largest medical device market in Europe, the United Kingdom presents significant opportunities for foreign manufacturers seeking UK medical device registration. The National Health Service (NHS), as the primary healthcare provider, is a major procurer of medical devices, highlighting the demand for innovative healthcare solutions in the UK market.
Understanding the UKCA Marking and MHRA Registration
Regulatory Authority
Medical devices sold in the UK regulated by The Medicines and Healthcare products Regulatory Agency (MHRA). Pure Global can assist with UK's medical device registration and act as your UK Responsible Person (UKRP), ensuring MHRA approval to sell in the British market.
Classification
Medical devices in the UK are classified according to risk, with the classification guiding the regulatory requirements and process for achieving UKCA marking and MHRA registration.
Key Requirements
For market entry, manufacturers outside the UK must:
- Appoint a UKRP to act on their behalf.
- Ensure compliance with UK MDR requirements and achieve UKCA marking for their devices.
- Register their devices with the MHRA through the UKRP, adhering to the specific deadlines for CE and UKCA marking transition.
Tailored Support for Market Entry
Our services are designed to streamline your regulatory process in the UK:
Assistance with product classification and identification of the UK regulatory pathway.
Compilation of technical documentation required for UKCA marking and MHRA registration.
Acting as your UK Responsible Person (UKRP), managing the MHRA registration process and ensuring compliance with post-market requirements.
Frequently
Asked Questions
What is the primary regulatory authority for medical device registration in the UK?
The primary regulatory authority for medical device registration in the UK is the Medicines and Healthcare products Regulatory Agency (MHRA). Pure Global can assist with navigating the UK medical device regulations to ensure UKCA approval for selling medical devices in the British market.
How are medical devices classified in the UK?
Medical devices in the UK are classified according to their risk level, as outlined by the UK medical device classification system. This classification guides the regulatory requirements and the process for achieving UKCA marking and MHRA registration. Higher-risk devices typically require more rigorous scrutiny and documentation.
What are the key requirements for foreign manufacturers to market medical devices in the UK?
Foreign manufacturers must: Appoint an MHRA UK Responsible Person (UKRP) to act on their behalf. Ensure compliance with UK Medical Device Regulations (UK MDR) requirements and achieve UKCA marking for their devices. Register their devices with the MHRA through the MHRA UK Responsible Person, adhering to specific deadlines for transitioning from CE marking to UKCA marking.
Why is appointing a UK Responsible Person important for foreign manufacturers?
Appointing a UK Responsible Person (UKRP) is crucial for foreign manufacturers because the UKRP acts on behalf of the manufacturer in dealings with the MHRA. The UKRP ensures compliance with UK MHRA medical device regulation, facilitates communication, and handles the registration and market access process, enabling the manufacturer to sell their medical devices in the UK.
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