Your UK Responsible Person
The UK MHRA expects the designated UKRP to hold a copy of the UK MDR compliant technical file for each medical device for which it is responsible. This includes a mandatory check that a relevant conformity assessment has been performed for the products, where applicable.
Your UKRP is responsible for holding technical documentation, declaration of conformity, and registering your compliant device with the MHRA. That means we represent your company’s interests with the MHRA as the first point of contact for questions relating to both conformance of your products with the UK regulations and the reporting of any adverse incidents and corrective actions.
We will undertake an initial review of the technical file for each device to ensure compliance with the relevant regulations and advise you of any issues or concerns to be addressed before the product can be registered with the MHRA. The initial review is an essential requirement to engage Umbilicus as your UKRP.
We will also work with you to establish a suitable post-market surveillance program to record and product performance issues reported during use.
Why do you need a UK Responsible Person?
The amended UK medical device regulations issued by the UK MHRA came into effect from January, 2021. They apply to all non-UK based manufacturers of medical devices of all classes including active implantable medical devices and In Vitro Diagnostic Devices (IVD).
Device manufacturers placing products in the UK market must comply with the amended regulations and cannot place product on the UK market without registration with the MHRA. As part of the manufacturer’s declaration of conformity, they must ensure that a UKRP is appointed to represent their products along with registration via MHRA.
A UKRP must be appointed whether a product enters the UK market with a CE mark under the extended transition arrangements or with a UKCA mark.