Regulatory Open Forum

​Hello everyone,

I'm looking for guidance on the requirement for UKCA marking for system components. If a system is UKCA marked with a UK Declaration of Conformity I would presume this covers all elements of the system, including many components that are currently CE marked under the low voltage directive or EMC directive (motors, power supplies etc.).
Many of these components may also be service spare parts, but are not items that are sold directly to customers in the UK. These items are purchased by manufacturing sites outside of the UK before being assembled into a complete system.
Is there a requirement for these components to carry the UKCA mark from 1st Jan 2022?
If not will CE marked components (including visible items such as monitors and keyboards) continue to be accepted indefinitely in the future providing the system itself carries the UKCA mark?

As a follow up to this I presume that ancillaries to the system that are not covered under the declaration of conformity (such as locally sourced printers or UPS systems) would all need to be UKCA marked from 1st Jan 2022?

Many thanks
Andy


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Andrew Brown
Quality and Regulatory Affairs Manager, Northern E
Beckman Coulter, Inc.
Brea CA
United States
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Hello Andy,

It might be in general application of a UKCA mark similar to the CE mark, however, I would definitely use care when applying because there is not yet any information specific to the UKCA mark.  There are three UKCA approved bodies where you can obtain a UKCA mark for medical devices.  We know it exists, will be applied to medical devices for the UK, but there is not yet an expected updated regulation.  Indeed this has been available since beginning of 2021 with requirement until June 2023.  The issue is the UKCA mark is being applied to the 2002 regulations when they have said there will be an updated regulation.  If you have a complicated system it might be beneficial to have the discussion with a UKCA Approved Body about how they would be expecting to regulate your medical device or contact MHRA directly for advice.  We can provide plenty of advice in the forum, but this is an area without guidance or regulation which should be confirmed with the leading authority, MHRA.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 28-May-2021 07:04
From: Andrew Brown
Subject: UKCA marking for system components

​Hello everyone,

I'm looking for guidance on the requirement for UKCA marking for system components. If a system is UKCA marked with a UK Declaration of Conformity I would presume this covers all elements of the system, including many components that are currently CE marked under the low voltage directive or EMC directive (motors, power supplies etc.).
Many of these components may also be service spare parts, but are not items that are sold directly to customers in the UK. These items are purchased by manufacturing sites outside of the UK before being assembled into a complete system.
Is there a requirement for these components to carry the UKCA mark from 1st Jan 2022?
If not will CE marked components (including visible items such as monitors and keyboards) continue to be accepted indefinitely in the future providing the system itself carries the UKCA mark?

As a follow up to this I presume that ancillaries to the system that are not covered under the declaration of conformity (such as locally sourced printers or UPS systems) would all need to be UKCA marked from 1st Jan 2022?

Many thanks
Andy


------------------------------
Andrew Brown
Quality and Regulatory Affairs Manager, Northern E
Beckman Coulter, Inc.
Brea CA
United States
------------------------------