Hi Edward,
when the UK transposed the MDDs into UK law they did it under UK MDR 2002. So the UK med device regulations diverged from EU regulations on date of application of EU MDR.
there is also obviously the additional requirements such as UK responsible person and the UKCA mark, which came into effect through additional UK regulations. These were to facilitate the UK exit from the EU. These are the EU exit regulations 2019 and then the more recent Medicines and Medical Devices act 2021.
You will need to maintain tech doc to meet the UK requirements,
Seb
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Sebastian Clerkin
Consultant
Ballincollig
Ireland
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Original Message:
Sent: 09-Jul-2021 09:53
From: Ed Panek
Subject: UK MDR transition period - Acceptance of MDD devices
Thanks, Sebastian. A question I have is then if a company is currently MDD CE does that mean as it conforms to MDR for EU it will need to retain its technical fille for MDD as its UK Technical File ongoing? Is UK MDR 2002 the same as EU MDD?
I would be very interested in your webinar.
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
Original Message:
Sent: 09-Jul-2021 09:27
From: Sebastian Clerkin
Subject: UK MDR transition period - Acceptance of MDD devices
there is different timelines for registration and when a CE only marked device will be accepted. please see below some images that may help. These are from an upcoming webinar I'm running.
Seb
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Sebastian Clerkin
Consultant
Ballincollig
Ireland
Original Message:
Sent: 09-Jul-2021 09:18
From: Ed Panek
Subject: UK MDR transition period - Acceptance of MDD devices
I thought the UK deadline was 9/1/2021 for Auth Rep and Registration with MHRA. Please confirm. Classification of devices has an impact.
Grace periods and deadlines for MHRA registration
The MHRA has set the following deadlines for registration:
- May 1, 2021: active implantable medical devices, Class III medical devices, Class IIb implantable medical devices and IVD List A devices
- September 1, 2021: Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B devices, self-test IVD products
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
Original Message:
Sent: 09-Jul-2021 08:45
From: Stacey Benser
Subject: UK MDR transition period - Acceptance of MDD devices
CE marked devices can continue being placed on the UK market until June 30 2023. From July 1, 2023 onward, a UKCA mark will need to be n the device in order to be placed on the UK market. You'll also need to have a UK Responsible person (importer) designated by December 31, 2021 and devices registered with the MHRA as required.
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Stacey Benser
Senior Quality/Regulatory Manager
York PA
United States
Original Message:
Sent: 07-Jul-2021 19:10
From: Anonymous Member
Subject: UK MDR transition period - Acceptance of MDD devices
This message was posted by a user wishing to remain anonymous
The MHRA guidance document - Regulatory medical devices in the UK
States that the legislation that applies in Great Britain is the EU MDD. (MDR will not be implemented in Great Britain)
Does it mean that at least until Jan 1, 2021, MDD devices can be still be marketed in the UK?