Senior Sales Executive | 3 Years of Experience
Vyankatesh Dhavale holds a Bachelor of Pharmacy (B.Pharm) and an MBA specializing in Operations and Supply Chain Management
Are you planning to launch your medical device in the UK? Understanding the MHRA medical device registration process is crucial for smooth market entry. In this guide, we’ll break down the registration process, costs, timelines, and key requirements to help you achieve compliance effortlessly.
What is MHRA Medical Device Registration?
MHRA registration is a legal requirement for manufacturers looking to place medical devices and in vitro diagnostic (IVD) devices on the UK market. It ensures compliance with UK-specific regulations, helping to maintain safety and efficacy standards.
Who Needs MHRA Registration?
UK-based manufacturers of medical devices and IVDs.
✅ Non-UK manufacturers through a designated UK Responsible Person (UKRP).
✅ Distributors and importers handling medical devices in the UK.
Step-by-Step Guide to MHRA Medical Device Registration
1. Classify Your Device
Your device classification determines the regulatory pathway. MHRA follows the UK MDR 2002 (as amended) for classification, similar to EU MDR rules:
- Class I, IIa, IIb, III (Medical Devices)
- A, B, C, D (IVDs)
Pro Tip: Higher-risk devices require certification from a UK Approved Body (UKAB) before registration.
2. Conformity Assessment & Quality Management System (QMS)
- Implement a Quality Management System (QMS) in compliance with ISO 13485.
- Choose a conformity assessment route based on device classification.
3. Prepare the Technical Documentation
This includes:
✔ Device description & classification rationale
✔ Risk assessment & clinical evaluation
✔ Instructions for use & labeling
✔ Performance testing & validation reports
4. Appoint a UK Responsible Person (UKRP) (For Non-UK Manufacturers)
A UKRP is mandatory for foreign manufacturers to represent their devices in the UK. They are responsible for:
✔ Registering the device with MHRA.
✔ Ensuring compliance with UK MDR 2002 regulations.
✔ Communicating with regulatory authorities on your behalf.
5. Submit Registration via MHRA’s Device Online Registration System (DORS)
- Pay the £240 registration fee.
- Submit the technical documentation and conformity assessment certificates.
- MHRA typically reviews applications within five business days, but delays may occur.
6. Receive Approval & Maintain Compliance
Once registered, your device will appear in the MHRA’s public database. Keep up with:
✔ Annual registration renewals (initial renewal after 1 year, then every 2 years).
✔ Post-market surveillance (PMS) and reporting any adverse incidents.
MHRA Medical Device Registration Fees & Timelines
MHRA Registration Fee: £240 per submission (up to 100 devices in one application).
Review Time: 5 business days, but can be extended if MHRA requests additional information.
Renewal: 1 year after initial registration, then every 2 years.
What Happens After MHRA Approval?
Once your medical device is successfully registered, you must:
✔ Monitor compliance with MHRA regulations.
✔ Ensure product traceability for post-market surveillance.
✔ Renew registration within the required timeframe.
Why Choose Operon Strategist for MHRA Registration?
At Operon Strategist, we specialize in:
✔ Hassle-free MHRA registration for medical device manufacturers.
✔ Expert guidance on UKCA marking & regulatory compliance.
✔ Comprehensive support from technical documentation to market approval.
Get expert consultation today! Contact us to simplify your MHRA medical device registration.
Talk to Our Experts and accelerate your UK market entry!
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FAQ
What is MHRA IVD registration in the UK?
MHRA IVD registration is the process of registering eligible in vitro diagnostic (IVD) medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) before placing them on the Great Britain market. Manufacturers must comply with the UK Medical Devices Regulations 2002 (as amended) and meet the applicable regulatory requirements.
Who must register IVD medical devices with the MHRA?
UK-based manufacturers placing eligible IVD devices on the Great Britain market must complete MHRA registration. Manufacturers established outside the UK generally require a UK Responsible Person (UKRP) to carry out regulatory responsibilities and register eligible devices with the MHRA on their behalf.
What documents are required for MHRA IVD registration?
Manufacturers typically prepare technical documentation, an ISO 13485-compliant Quality Management System (QMS), ISO 14971 risk management documentation, performance evaluation documentation, labeling, Instructions for Use (IFU), a Declaration of Conformity, post-market surveillance procedures, vigilance documentation, and manufacturer information. The exact documentation depends on the device classification and applicable regulatory requirements.
Is UKCA marking required before MHRA registration?
Manufacturers should ensure their IVD devices comply with the applicable UK regulatory framework before placing them on the Great Britain market. Depending on the device type, classification, and applicable transitional arrangements, UKCA marking or another accepted conformity marking may be required before or alongside MHRA registration.
Senior Sales Executive | 3 Years of Experience
Vyankatesh Dhavale holds a Bachelor of Pharmacy (B.Pharm) and an MBA specializing in Operations and Supply Chain Management, with a minor in Marketing. He brings experience in domestic and international business development, strategic client relationship management, and sales of medical device regulatory consulting and turnkey project services. His expertise includes supporting market entry and regulatory service requirements related to CDSCO registration, EU MDR CE marking, US FDA regulations, and ISO 13485 quality management systems.
