Hello Peter,
You should just concentrate on meeting the new UK regulations for devices post-Brexit, as per the link you identified. If the manufacturer is not located in the UK, then he must designate a UK Responsible Person (UKRP) to make the registrations on his behalf.
As an aside, Class III devices from non-UK manufacturers did not need to be registered with MHRA before Brexit, unless the devices were from non-EU manufacturers who had designated an Authorised Representative in the UK.
While non-UK manufacturers wishing to export devices to the UK post-Brexit should already have their UKRPs designated, device registration needs to take place in accordance with the MHRA's classification-dependent timescale. So for the Class III device you mention, this must be registered with the MHRA's DORS database before 1 May 2021.
If you still need help, send me an email, or we can discuss on the phone.
Best wishes.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Ltd
UK Responsible Person services
Christchurch, UK
+44 1425 489208
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 08-Feb-2021 11:55
From: Peter Miko
Subject: UK registration of Class III. implantable medical devices, CE-certified in the period between January 01-May 26, 2021
Dear Colleagues,
could you please help me correctly interpret the following issue:
in the UK Class III. implantable medical devices, CE-certified in the period between January 01-May 26, 2021 undergo the same registration procedure as the devices already CE-certified before January 01, 2021 (before the Brexit)?
Does the procedure described at https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#when-register apply for these Class III. devices?
regards
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
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