The ultimate guide to UKRP from Jan 1st 2021
Brexit is here, for better or worse. And that means changes to how international manufacturers of medical devices must register their products in the UK.
Starting from day one in 2021 the landscape is changing, so read on for the ultimate guide on your new best friend, the UKRP…
*Disclaimer - the guidance is constantly being updated and, at the time of writing, subject to parliamentary approval.
So, regulations are changing?
Yes, but only in the UK. Once the UK has officially left the EU (which at the time of writing is the most likely scenario), England, Scotland, Wales and Northern Ireland (but not Ireland - that’s not part of the UK) no longer need to stick to the European Commission’s framework for medical device regulation. This is currently done by obtaining a CE mark through the Medical Device Directives (MDD), last updated and harmonised for all EU member states back in the 1990’s. After Jan 1st the UK is free to do whatever it likes, including creating brand new regulations from scratch. However, creating reams of complex technical documentation requirements that govern all possible medical devices on market is not quick or easy, so the UK is simply keeping the MDD framework for now (well, a local version for local people called the UK MDR 2002) and relabelling it as the UKCA marking process. At the same time the UK will continue to accept CE marked products from Europe until July 1st 2023. So, first point to note - don’t panic! You have time!
Meanwhile Europe, in its continued collective wisdom, will be revamping the rather outdated MDD with the spanking new Medical Device Regulations (MDR) which are more robust in terms of clinical validation of higher risk devices, and have a far stronger mandate in terms of quality management, post-market surveillance and clinical follow up. The MDR comes into effect in May 2021, so after that date to sell into the EU you need to be prepared for MDR not MDD. If you have an existing MDD CE mark, you can keep it under specific conditions, or until 26th May 2024, but the UK will only accept it until June 2023. See, easy?
What does this mean for me?
From Jan 1st 2021 there will be a new requirement for all medical devices placed on the UK market to be registered with the MHRA (the UK’s arms-length government regulator), because the UK will no longer be part of the EU registration processes. This will create some extra leg work for both UK companies and international ones as they will all have to register separately with the MHRA and apply for an EU CE mark, if they want to continue to sell into the remaining 27 members of the European Union.
So, I need to register my device by Jan 1st?
Not necessarily! The MHRA knows there are hundreds of thousands of medical devices out there on market (and they only have a few under-resourced staff) so a rather cunning staggered deadline approach is being used. Starting from Jan 1st, various classes of device will need to be registered at different time points throughout the year. There are some nuances around devices from Northern Ireland, which frankly are too time-consuming to explain, but let’s focus on mainland UK for now. Look, I drew you a diagram with the deadlines to make it simple…
So, second point to note - don’t panic! You have time! Especially if you are selling AI-diagnostic based software, you will be in at least class IIa so you can chill out until September and focus on your EU MDR CE mark instead. (Actually, you should be panicking about that…)
OK, so how do I register?
It totally depends on whether you are based in Great Britain or not! If you are, you can do it yourself. If you’re not, then you need someone based in Great Britain to do it for you. This is known as a UK Responsible Person, defined as someone qualified to act on your behalf and essentially do the interacting with the MHRA for you. The qualification criteria are yet to be announced, but don’t just choose your only British friend you met backpacking in Guatemala, it will have to be some who knows what they are doing (like us at Hardian Health!)
There are various things that need to be done as part of getting the UKCA mark, including putting the name and address of your UKRP on all your product labelling. So choose your UKRP wisely! *cough cough
Manufacturers should appoint a UK Responsible Person (UKRP) as soon as possible from 1 Jan 2021
Wait, all I need is a local person to register my product?
No. There’s more to it than that! Your UKRP will have a list of responsibilities, including telling the MHRA about any adverse events or complaints about your device, and performing any and all interactions with the MHRA that you would normally do. Essentially, your UKRP is your single point of contact with the UK regulatory authorities. So choose someone in their good books!
UK companies will still of course also need an EU Authorised Representative (known as EAR), as they are no longer in the European Union. So, they save on the need for a UKRP, but still need an EAR. Sound good?
How much does it all cost?
Not much. The MHRA fees are ÂŁ100 per medical device, and for each subsequent change you want to make to an already-registered device (we advise making changes in bulk to save costs!). Our UKRP services are based on a fixed annual fee, competitively priced to be a cost effective solution to your problem of not having an established UK base!
Sign me up!
Gladly! Please contact us using this big button right here, and we’ll have you sorted in no time.
Hardian Health is clinical digital consultancy focussed on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
