Do you want to launch or maintain a Medical Device or IVD on the UK market?
Are you looking for a UKRP to support you?
UK Responsible Person (UK) – medical devices and in-vitro diagnostics
As of 1st January 2022, non-UK based manufacturers are legally required to appoint a UK Responsible Person (UKRP) to act on their behalf with UK Regulators in order to place their devices on the market here in the UK.
IMed are pleased to offer this UK Responsible Person service.
As your UKRP, IMed will:
- Register your devices with the MHRA
- Ensure the Declaration of Conformity and Technical documentation has been drawn up
- Keep a copy of technical documentation for inspection by MHRA
- Provide information to MHRA upon request
- Inform the manufacturer of complaints and incidents
- Act as your representative here in the UK
A manufacturer’s choice of UK RP is an important business decision. Naturally, you want to work with a trusted partner, who can responsibly represent you with the UK MHRA. You may also wish to use someone independent of any distribution or import relationships and contracts already in place, to ensure no routes to market are closed down. So, selecting IMed as your UKRP ticks both of these boxes.
Further more we will:
- Inform you of any regulatory changes that will impact your business
- Advise you on the CE Mark or UKCA mark regulatory pathway to ensure a smooth route to market
At IMed, we do things a bit differently – investing time in getting to know our clients and their businesses. We value the business they give us of course, but we also respect the trust being shown in IMed, whenever we are selected as a regulatory partner; and never more so than when being appointed as a manufacturer’s UK Responsible Person. As your UK RP, we will represent your business professionally, efficiently and with complete regard for both patient safety and your company’s reputation with regulators and the wider market.
So just ask us for whatever you need, and we’ll find the best way to deliver it to you. And, if you aren’t sure what you need – just talk to us and we can help with that too!
Please contact us now on 01295 724286 or email us at email@example.com, so that we can discuss your situation and tell you how we can help you get your products compliant and on sale.