In relation to the ongoing Brexit process, the regulatory landscape for medical devices and in-vitro diagnostic devices in the United Kingdom is significantly changing.
Current guidance from Medicines and Healthcare products Regulatory Agency (MHRA) requires non-United Kingdom based manufacturers to designate a United Kingdom Responsible Person (UKRP) from Jan 1st 2021. The UKRP is essentially an authorized representative established in the United Kingdom with the role to act as the manufacturer’s representative in the communication with the MHRA. This is required for both new medical devices or to continue to place current medical devices on the United Kingdom market.
The UKRP is for example required to register the manufacturer’s products with MHRA, as well as review and keep available a copy of the technical documentation for potential inspection by the MHRA to demonstrate the conformity of the device.
We advise to use an independent UKRP professionally focusing on the regulatory aspects which are separated from the supply chain and import/distribution of products.
QAdvis has 10 years of experience supporting and being authorized representative in the EU, handling registration tasks, reviewing and safeguarding technical documentation for many medical device and IVD manufacturers on all continents.
Based on this infrastructure we now also offer UKRP services from our office QAdvis UK Ltd. in Edinburgh.
We are delighted to offer our professional services and to support you with successful post-Brexit clearance in the United Kingdom.
Please use the contact form below
or contact Chief Sales Officer Per Sundström for quotation and details.
Phone +46 8 621 01 05 or send an mail
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