MHRA Consultation

[Anna DUK]

The Medicines and Health Regulations Agency (MHRA) are holding a consultation on changes to the regulations for medical technology, and as part of this they are proposing to remove the requirement for UKCA marking for tech which has been approved for use in the UK. At present, medical devices need to have a UKCA mark to be placed on the Great Britain market.

This change would mean that a UKCA mark would not be required on the device or its labelling such as packaging and instructions for use. However, it is important to note that devices would still need to be registered with the MHRA and will be monitored for performance and safety in the usual way.

In the future, MHRA also plan to require tech manufacturers to assign a Unique Device Identifier (UDI) – an internationally recognised digital barcode that can be scanned to provide further detail and improve traceability - to all medical devices before being introduced to the UK.

To inform our response to this consultation we would be grateful to hear your responses to the below questions by Friday 3rd January:

• Do you find having the UKCA marking on tech devices and their packaging useful, and why?
• Do you have any concerns about a potential move to the use of the unique device identifier (UDI) on tech devices and their labelling?
• Do you have any other thoughts on this proposal you’d like to share?

 

[everydayupsanddowns]

Is the UKCA mark a new thing? A post-Brexit version of the CE mark? I’m not sure I’ve even heard of it! Though I find the CE mark reassuring.

I hope the UDI will help prevent those bogus products like the useless non-invasive non-functional unregulated ‘glucose watches’ that are mentioned from time to time on the forum, and must have hoodwinked many people out of their hard-earned cash!

 

[Anna DUK]

Is the UKCA mark a new thing? A post-Brexit version of the CE mark? I’m not sure I’ve even heard of it! Though I find the CE mark reassuring.

Yep, exactly that!

 

[Bruce Stephens]

Is the UKCA mark a new thing? A post-Brexit version of the CE mark? I’m not sure I’ve even heard of it!

It was intended to replace CE marks in the UK. (This month, actually.) But (like Imperial measures) it seems manufacturers haven't been excited by the opportunities for two different systems for the same thing so for things which have a CE mark, that can be used in the UK.

Govt announces UKCA U-turn | Journal Of Trading Standards

<p>British businesses will now be able to use the CE mark on their products indefinitely, in a significant climbdown for the Government’s post-Brexit regulatory reform plans. The UKCA mark was previously intended to replace the CE mark on goods being sold in Great Britain, with the CE mark...

www.journaloftradingstandards.co.uk

 

[everydayupsanddowns]

Well I’m not entirely surprised.

I can’t imagine many manufacturers would be overjoyed at having to jump through additional (doubtless expensive) regulatory hoops to sell in their home market, having got their product CE Marked for selling into Europe.

 

[Bruce Stephens]

I can’t imagine many manufacturers would be overjoyed at having to jump through additional (doubtless expensive) regulatory hoops to sell in their home market, having got their product CE Marked for selling into Europe.

No. I guess now we're outside EEA we're forced to have our own system for those products not intended for sale in the EU. It was just a bit daft trying to make that the main (or maybe only) one since we want to continue making things for the EU market. (And the idea of increasing use of Imperial units was just silly on a number of levels.)

 

[trophywench]

and yet - it was us that started it with the kite mark!