Regen Marketing–Your Trusted UK Responsible Person (UKRP) Services
About Us
Established in 2005, Regen Marketing Limited is registered with the UK Medicines and Health Regulator to provide:
- The UKRP services focused on Medical Devices.
- Hassle-free UKC registration mark with the UK Medicines Health and Regulatory Authority (MHRA)
Our Services
UK Responsible Person
As your UK Responsible Person, we will work on your behalf to ensure new products are registered for UKCA and the dossier for existing products complies with UK Medical Device legislation
Device Registration
As your UKRP, we make medical device registration in the UK efficient, ensuring you can confidently market them directly or through independent partners.
Why choose Regen Marketing as your UK Responsible Person? (UKRP)
- As a trusted provider of UK Responsible Person services, we will liaise with the UK MHRA, hold samples, and ensure both parties are compliant. Read more...
- We act independently of your sales agent or distributor, leaving you flexible to make changes or appoint additional sales agents without impact upon your UK medical device registration
- Our consultancy fees are transparent, allowing you to budget easily.
- Uniquely, we offer a commission-based scheme to help lower market entry costs.
- We can also efficiently achieve UKCA registration for you. Read more...
To see Goverment Guidance: Click Here
What can you expect from us?
UK Responsible Person
We will act as your UK Responsible Person, a critical requirement for compliance with UKCA regulations managed by the Medicines and Health Regulatory Authority (MHRA).
As your UKRP service providor we will:
- Register your devices for UKCA and keep available samples and copies of all relevant documents and certificates for inspection by the MHRA.
- Cooperate with the MHRA on any preventive or corrective action required to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Provide samples or access to the device, should MHRA request it. Enquire
- Provide MHRA with all the information and documentation necessary to demonstrate the conformity of a device, should they request it.