The Importance of Proper MHRA Registration
Legal background
To legally sell, lease, lend, or gift medical devices in Great Britain, manufacturers must ensure timely MHRA registration through their UK Responsible Person. Choosing an experienced UK Responsible Person like Obelis UK Ltd. ensures full alignment with MHRA expectations, eliminates uncertainty, and supports smooth market entry.
Non-compliance could result in:
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- Regulatory enforcement actions including product withdrawal
- Delays in market access and loss of business opportunities
- Inability to legally supply products to distributors or end-users
- Reputational damage and reduced stakeholder trust
Our services
How to Register Medical Devices with the MHRA
To comply with UK regulations, you need to know how to register a medical device promptly. Obelis as your designated UK Responsible Person, will register your medical devices with the MHRA, regardless of classification. We support:
- Class I, IIa, IIb, III medical devices
- Custom-made devices
- IVDs and performance evaluation devices
- Systems and procedure packs
- Preparing and submitting your technical documentation
We ensure your device is compliant with UK MDR 2002, manage the technical documentation, and keep your registrations up to date with MHRA. Whether you need to register multiple device classes together or need strategic advice on CE vs. UKCA marking, Obelis will handle the complexity on your behalf. We also ensure your labels meet UK regulatory standards, including affixing the UK Responsible Person’s name and address.
