Akanksha,
Last time I heard that the UK is in the process of establishing a regulatory system that mirrors the key elements of both EU MDR and the EU IVDR, aka the "UK MDR 2019." MHRA will follow the same transitional periods set to comply with the new requirements under MDR/IVDR. The UK has now entered a transition period in which it will negotiate future business and trade agreements with the EU. The MHRA recently confirmed that, during this transition period (due to end on 12/31/2020), under the withdrawal agreement the UK must, at the request of the manufacturer, ensure that all information held by UK NBs about CE certificates is transferred to an NB in a EU27 country before the end of the transition period. The manufacturer is responsible for submitting such a transfer request in good time. After the transition period, all medical devices would need to be registered with the MHRA before being placed on the UK market, in addition to parallel registration requirements in the EU. The UK government states that where a device manufacturer is not established in the UK, registration of a product with the MHRA must be undertaken by a "UK Responsible Person" established in the UK and with a UK registered address who will take responsibility for the product in the UK. In short, your products approved by NB based in the UK will require new "CE-marks" in the EU, while products approved in the EU will require parallel registration in the UK by an NB (whether its UK or EU based) with a UK presence to sell in the UK. Also,while the MHRA would continue to perform its PMS of medical devices on the UK market, it can no longer be involved in the assessment of medical device safety through the EU regulatory network. It will no longer receive post-market safety data that is currently shared across EU member states. That said, a separate set of requirements for PMS activities, including vigilance reporting for UK should be expected. Finally, while manufacturers of lower risk devices can self-certify by way of a DoC, higher-risk devices (Class II and III medical devices and certain IVDs) must be certified by an NB. If you wish to place a new device that requires an NB to carry out a conformity assessment onto the EU market, you will need to use an NB based in an EU Member State. I hope it helps answer your questions.
Best,
Jo
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Jo Huang RAC
Assoc Manager - Regulatory Affairs
Irvine CA
United States
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Original Message:
Sent: 04-Jun-2020 10:30
From: Akanksha Asbe
Subject: UK Brexit Requirements
Thank you!
Do we need a separate DoC for the UK? Are other any technical requirements per UK med device regulations for class II products?
What about reporting? Is there a separate vigilance requirements for the UK? What is the cost for UK registration?
Thanks,
Akanksha
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Akanksha Asbe
Regulatory Affairs Specialist II
Clinton MA
United States
Original Message:
Sent: 03-Jun-2020
From: George Tiller
Subject: RE: UK Brexit Requirements
Hi Akanksha,
The below two links have a lot of the answers to your questions.
But to summarize, if your legal manufacturer is not based in the UK, then yes your company will need an in-country "UK Authorized Representative" also known as "UK Responsible Person."
http://www.advenamedical.com/headlines/uk-responsible-person/
http://www.advenamedical.com/medical-devices/brexit/
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George Tiller
Los Angeles CA
United States
Original Message:
Sent: 03-Jun-2020 17:28
From: Akanksha Asbe
Subject: UK Brexit Requirements
Hi everyone,
We are already approved in Europe and planning to sell in UK now. What are the requirements for UK due to brexit? Do we need a in country representative?
Thanks!
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Akanksha Asbe
Regulatory Affairs Specialist II
Clinton MA
United States
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