UKCA for devices already placed on the market

#1
Hi everyone,

I have tried to find some clear guidance regarding UKCA requirements for devices already placed on the market, prior 30th of June 2023.

Is there requirements concerning the label for devices already on the market, as an example?

Example: We have a reusable class IIb device. Do we have to do anything with devices already placed on the market prior to 30th of June 2023? Is it considered placed on the market if its still in the warehouse of the distributor in UK?

Thanks for your advice and expertise
 
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Ronen E

Problem Solver
Moderator
#3
Apparently the following is of special interest/usefulness:
Secondly, the government intends to introduce the transitional arrangements, as set out in Option 2, for general medical devices and IVDs that hold a valid certification/declaration of conformity to the CE standard, issued under the EU Medical Devices Directive, the EU Active Implantable Medical Device Directive or the EU in vitro Diagnostic Medical Devices Directive before the regulations take effect. The government would like to establish a transitionary arrangement for these products which will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years (for general medical devices) and five years (for IVDs) after the new regulations take effect, whichever is sooner.
With the following caveats:
  • No "significant changes in design or intended purpose" are allowed
  • All post-market requirements applicable to the new [UK] regulatory framework must be complied with
The transitional concession related to MDR/IVDR clearance seems of questionable value to Manufacturers, since UKCA requirements will apparently be much less onerous than the MDR's/IVDR's (and more aligned with the MDD/IVDD).

I'm not sure what exactly are the rules for "Placing on the Great Britain Market".

Please note that for "Placing on the NI Market" (so to speak), CE marking compliance is necessary, regardless.
 
Last edited:

dgrainger

Trusted Information Resource
#4
The UK's MDR will be based on the EU's MDR/IVDMDR. This is in line with the strong call for the UK to align with Europe.
 

Ronen E

Problem Solver
Moderator
#5
The UK's MDR will be based on the EU's MDR/IVDMDR. This is in line with the strong call for the UK to align with Europe.
Oh. Apparently I wasn't tuned in to the change of wind...
"The strong call for the UK to align with Europe", as in "let us go crazy too"...? :lol:
 

Ronen E

Problem Solver
Moderator
#6
Seems like the British government is a bit behind on updating the public on this topic (emphasis added):
Legislation that applies in Great Britain
Devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which, prior to the end of the transition period, gave effect in UK law to the directives listed below:
This means that the Great Britain route to market and UKCA marking requirements are based on the requirements derived from the above EU legislation.
Regulating medical devices in the UK

This webpage, however, was last updated 1 January 2022...

@dgrainger, do you know of a reliable online source that covers the change in approach you indicated?
 
#9
Is there any indication of when (or how long it may take) before the consultation recommendations and outcome is implemented by MHRA?

Its getting dangerously close to the window where decisions are made on goods being ordered/produced/shipped (from Asia in particular), and from experience companies are still awaiting on NB audits/certifications for UKCA. This may result in gaps in supply because in black and white, this hard deadline of 30th June 2023 is still the official line (or is it?).

I noticed some consultancy companies popping up on google searches already running with the news of this softer phase in.
 
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