New Blog available now on UKCA Consultation response from the MHRA.
As of 1st January 2021, the UK has now left the European Union.
For the UK IVD market, IVD devices will need to comply with the new UKCA mark from 2023.
Manufacturers who are not based in the UK, will need to appoint a UK Responsible Person, which is broadly equivalent lo the EU Authorised Representative.
Appointment of the UK Responsible Person, or UKRP should be made as soon as possible. New devices need to be registered within the MHRA Device Registration portal from the 1st January 2021 although a grace period has Oeen given for this.
Failure to meet these grace period may result in removal of your devices from the market and potential fines from the MHRA.
IVD Annex II List A products
IVD Annex II List B products, Self-test IVDs
We take the responsibility of taking on the UKRP role very seriously, as we will be sharing liability with the Legal Manufacturer when we place products on market. However we also want to make the process for selecting and working with a UK Responsible Person as easy as possible ily providing a clear process for engagement and device registration.
Meeting new customers is the fun bit, we love making connections and understanding how we can support IVD providers placing products on the UK Market. Contact us via firstname.lastname@example.org or complete this simple questionnaire. Once completed one of our experts will be in touch with you and provide a clear, fair and reasonable quote for our services based on the number of devices that you wish ta register.
We will provide a clear, fair and reasonable quote which you can view and accept online.
Once you have accepted the quote online we can begin work to setup the UKRP Appointment Agreement and help you prepare a Letter of Designation to appoint us a your UK Responsible Person (don't wony, we will provide you with a template!).
Our experts will be available to answer any questions you may have, and discuss what the responsibilities of lhe UKRP is. This is typically done over telephone or video calls.
All devices placed on the UK market are required to meet the requirements of the UK Medical Device Regulation 2002, including all the additional statutory instruments that have been published as part of the transition from the European Union. But don't worry, we .viii perform a review of your technical files to check that you have everything you need to register your products.
IVDeology UKRP is registered as a UKRP provider within the MHRA Device Registration Database and one of our experts will register the devices on your behalf, using the infonnatian that you have provided. We will get everything ready, upload all the required documentation and pay the registration fee for your devices, we will inform you when this has been completed.
Confirmation of registration ily the MHRA typically takes 5-10 days, although in times of high demand, this may take considerable longer.
We will let you know as soon as we have confirmation of registration.
You have new or updated devices? No problem!
We can add new or changed devices on the database on your behalf (subject to additional registration and administration fees). We can also requesl certificate of free sales via the database if required (subject to additional registration and administration fees).
So the devices are registered - Hurrah!
But we don't stop there, once the devices are on market we will continue to monitor the market and communicate any notifications from the MHRA, or from any customers or distributors.
We will monitor customer and regulatory communication coming in via our dedicated e-mail. These communications will be forwarded to you.
Our team of IVD experts will support you on any vigilance activity including incident reports and product recalls.
At the end of the year, we will prepare an annual Post Market Surveillance Report with all activity that have Oeen performed. This is a key requirement of your Quality Management System.
Once you're all set up, we only charge an annual flat fee and for any hours that we work on your behalf.
IVDEOLOGY UKRP - Keeping Watch & Keep In Touch
The transition to the UKCA process will be a challenging time1 We offer an additional service to provide ongoing quality and regulatory support to help you navigate the complexities of the UKCA transition.
For further information book a call with us.