Regulatory Support services
The regulations for marketing authorisation of medical devices in the UK changed in January 2021 after the UK left the European Union. Over the coming years the current CE mark will no longer valid in the UK, and will be replaced by the UKCA mark. The CE mark will continue to be valid during a period of transition. All non-UK manufacturers are now required by law to appoint a UK Responsible Person (UKRP) to enable them to register their products on the British market with MHRA. Platform 14 is here to help navigate the new regulatory landscape.
UK Responsible Person
After the United Kingdom left the European Union, medical device companies must adjust to guidelines outlined by the Medicines & Healthcare products Regulatory Agency (MHRA). The guidance specifies that the representative in the UK will be termed the UK Responsible Person (UKRP). A UKRP must be appointed and must register the manufacturer, any relevant importers, and the devices with the MHRA. The MHRA plans to replace the CE mark with a UK Conformity Assessment (UKCA) mark by June 30, 2023. Platform 14 can help with the transition for existing and new products entering into the UK
European Responsible person
The EU MDR aims at improving medical device safety for patients and other end users. To achieve that goal, it introduced new, stricter requirements for the manufacturers of medical devices released to the EU market. The transition period to become EU MDR compliant for manufacturers of existing devices is 4 years, but only until any change to the product is implemented. Our sister company Agenoria is here to help with this transitions and regulatory support, please contact us for more information.
Let's Work Together
It’s simple – here at Platform 14 we will work with you, as your partner to drive your sales, market penetration and profitability within your chosen market. In addition, you will benefit from our years of experience launching and cultivating products within the UK and European markets.
At Platform 14, we nurture and take great pride in understanding and expanding our partnership network. We exist for our partners success and welcome new partners into our expanding healthcare product distribution network.
If you are interested in working with Platform-14, please fill out the form below. We look forward to hearing from you.