UK Responsible Person (UKRP)

Since 1st January 2021, all non-UK based manufacturers are legally required to appoint a UK Responsible Person (UKRP) to place their devices on the market in Great Britain. More Info here

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Sterile Management Systems Ltd are proud to offer UKRP service globally to Medical Device & IVD manufacturers.

Selecting a UKRP is entirely the manufacturer’s choice. Naturally, you will want to work with a trusted partner who will responsibly represent you with the UK authorities. Sterile Management Systems team collectively have 100+ years Medical Device and regulatory experience meaning we are perfectly placed to help.

Benefits of selecting S.M.S as your UKRP Partner

Registration with MHRA

The UKRP is responsible for ensuring that Medical Devices / IVD Devices entering the UK market are fully registered with the UK Competent Authority, Our team will carry this out and maintain on your behalf

Provide relevant info to MHRA

The UK Competent Authority requires that the UKRP retains / has immediate access to the Technical Documentation pertaining to each registered device. S.M.S will hold copies on our secure file server, where requested we will act liaise with the MHRA directly

Keep you informed of any Complaints or Incidents

As the registered and published UK Representative for your product, Health Authorities and the public may contact us about an issue with your device, in these cases we will ensure you are informed and assist you with any resulting actions

Professional yet Affordable

We pride ourselves in service and fairness. We are genuinely interested in helping you and your business achieve its global reach, in turn helping more patients gain access to the best and latest medical technologies.

We believe this should not be prohibited by cost