MHRA Recent Communication and Guidelines
By DTA | 16th December 2020 | News
The Brexit transition period is coming to an end on the 31 December and MHRA have recently contacted all manufacturers with updated guidance and actions required before 1 January 2021.
This article reviews the new information on the government website that we believe currently relates to manufacturers of custom-made dental devices.
Transition from 1 January 2021
The government website seems to suggest that if you work in England, Wales and/or Scotland, you do not need to do anything urgently before 31 December 2020, current registration requirements will continue to apply.
If you registered with the MHRA before 1 July 2018 and have a registration number that begins with 'CA****' you will need to re-register your detail and devices on the DORS system from 1 January 2021. Read more on the government website.
You must also make sure that you are prepared for the MDR regulatory changes that come into force on 26 May 2021. This date was extended from 26 May 2020 due to the current covid-19 pandemic. Find more information about what you need to do before 26 May 2021 on the DTA website and the MDR Summary article coming in the February issue of The Technologist.
From 1 January 2021 the following devices in Great Britain (England, Wales and Scotland) will need to be registered with the MHRA under existing arrangements:
- Class I medical devices
- custom-made devices
Where the manufacturer is in the UK or the Authorised Representative is in Northern Ireland, the following devices should continue to be registered with the MHRA on the same basis as they are now:
- Class I devices
- custom-made devices
- general IVDs
If you are based in Northern Ireland you will need to take action now. You will need to inform MHRA that you are placing a device onto the Northern Ireland market, the government state that there will be no grace periods granted for registering custom-made dental devices because existing registration requirements continue to apply:
Placing a device on the Northern Ireland market
In some circumstances, it will be a requirement of the UK MDR 2002 from 1 January 2021 that you inform the MHRA when you first place your device on the Northern Ireland market.
You must register if you or your company sells, leases, lends or gifts:
• Class I devices, custom-made devices or general IVDs you have manufactured, but only where the manufacturer or its Authorised Representative are based in Northern Ireland
If you have already registered your device with the MHRA for the purposes of Northern Ireland, it can then be placed on the Great Britain market and will not need to undergo any further registration in Great Britain.
The government website point to existing guidelines which aim to help manufacturers understand compliance requirements for the manufacture of custom-made medical device.
Preparing for 26 May 2021
The DTA have published a number of articles and also shared guidelines and templates with our membership in preparation for the new MDR regulation taking effect from 26 May 2021. DTA Members can find links to various resources on the DTA website
Find more information about registering devices using GMDN codes within the DTA Member guidance documents under MHRA tab.