It is well known that from January 1, 2021, medical devices to be placed on the UK market are obliged to follow a new Regulatory regime. Currently, the UK market is a witness to many Regulatory changes, with the impact of Brexit. The UK’s existing Regulatory Authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), has taken over the European Union (EU) responsibilities, ultimately changing the UK regulations.
As per the new regulations, medical device manufacturers who are placed outside the UK and are willing to enter the UK market, shall appoint a UKRP (United Kingdom Responsible Person). The UKRP will act on behalf of the non-UK manufacturers and take on the Regulatory responsibilities, with respect to the MHRA and user to successfully register and launch the devices in the UK. Moreover, we will notice the new United Kingdom Conformity Assessment (UKCA) mark on the devices, instead of, or as well as, the well-known CE mark. So, what do all these changes mean to the medical device industry? How can the manufacturers align with the new regulations? One must have a clear understanding on the following:
- Overview of the UK medical devices market
- Overview of the MHRA
- Routes to market the medical devices in Britain and Northern Ireland (NI)
- Who is a UKRP?
- Roles and Responsibilities of a UKRP
- Solutioning Models
To give you a better understanding on the same, Freyr is bringing an exclusive webinar on, “Post Brexit Scenario for Medical Devices: Appointing a UKRP”, scheduled on April 21, 2021 for AMR, EU and RoW regions. Won’t you wish to grab the insighs from industry experts? Register now!