UK Responsible Person
IMed provides trusted representation services, acting as your UK Responsible Person and EU Authorised Representative to keep your medical devices compliant and on the market.
As your appointed responsible person, IMed acts as a trusted bridge between your business and regulatory authorities. Protecting patient safety, market access, and your brand reputation.
Your Trusted UK Responsible Person
Since the 1st of January 2022, all non-UK manufacturers must appoint a UK Responsible Person to represent them before the MHRA when placing medical devices or IVDs on the UK market.
IMed Consultancy is a fully compliant, ISO 13485 certified, UKRP with the expertise to handle every aspect of your UK representation.
As your UK Responsible Person, IMed will:
We go beyond compliance, offering proactive support, fast communication, and peace of mind that your UK obligations are always met.
European Authorised Representative (EC REP) Services
If your business is based outside the European Union, you must appoint a European Authorised Representative to place your device on the EU market under MDR or IVDR.
IMed EUAR acts as your independent authorised representative, ensuring your documentation, declarations, and reporting comply fully with EU requirements.
As your EC REP, IMed will:
- Maintain your Technical Documentation and Declarations of Conformity
- Register your devices with the relevant Competent Authorities
- Manage communication between you and EU regulators
- Support vigilance and post-market reporting
- Provide guidance on MDR and IVDR updates
With IMed EUAR as your authorised representative, you gain a partner who values clarity, responsiveness, and regulatory precision.
Why Choose IMed?
Choosing the right responsible person or authorised representative is critical for your market access and compliance reputation. IMed offers a partnership built on experience, transparency, and integrity.
You’ll benefit from:
Frequently Asked Questions
Appointing a representative can raise questions about responsibilities, timelines, and documentation. Here are some of the most common queries we receive.
A UK Responsible Person is a legal representative appointed by a non-UK manufacturer to handle MHRA registration, maintain documentation, and liaise with regulators for medical devices and IVDs marketed in the UK.
An European Authorised Representative (EC REP) is required for non-EU manufacturers placing devices on the EU market. They ensure compliance under MDR and IVDR and communicate with Competent Authorities.
Yes, if you distribute products in both markets, you must have a UK Responsible Person for the UK and an Authorised Representative for the EU. IMed can handle both under one trusted partnership , also giving you access to IMed’s wider expertise and compliance services.
Timelines vary by product class, but IMed’s proven track record and experienced team manages registrations efficiently to minimise delays and ensure continuous compliance.
Partner with IMed Consultancy
Whether you need a UK Responsible Person, European Authorised Representative, or both, IMed Consultancy provides clear, compliant, and responsive representation services that keep your devices on the market and your business protected.