Navigating UK Medical Device Regulations: Ensuring Compliance for Market Success
When navigating the UK medical device regulatory landscape, AF Pharma is here to assist you as a reliable UK Responsible Person (UKRP). As the UK's independent system requires non-UK manufacturers to appoint a UK-based representative, AF Pharma offers expert support in fulfilling this requirement and taking on the responsibility for your product in the UK market.
With our in-depth knowledge of UK laws and regulations, based on the EU-MDR 2017/745 and EU-IVDR 2017/746, AF Pharma serves as your dedicated UKRP. We ensure that your medical devices comply with all necessary requirements and are registered with the Medicines and Healthcare products Regulatory Agency (MHRA), providing you with a seamless pathway to market success in the UK.
Trust AF Pharma as your experienced partner in meeting UK regulatory obligations. Together, we can navigate the complexities of the UK medical device landscape, allowing you to focus on delivering innovative and life-changing medical solutions.