UKCA for devices already placed on the market

E

EmiliaP

Registered
#1
#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
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Moderator
#3
#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.
Click to expand...
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

dgrainger

Trusted Information Resource
#4
#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

Ronen E

Problem Solver
Moderator
#5
#5
dgrainger said:
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.
Click to expand...
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

Ronen E

Problem Solver
Moderator
#6
#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.
Click to expand...
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?
 
K

kenbarlow

Registered
#9
#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.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Newbie22 UPDATE UKCA; UK 12 month extension (Future regulation of medical devices - extension of standstil period) UK Medical Device Regulations 4
S MDD CE Marking & UKCA Marking UK Medical Device Regulations 2
Newbie22 UKCA - Placing on the market after CE certificate has expired Manufacturing and Related Processes 6
M UKCA EU Medical Device Regulations 5
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
S UKCA transition Medical Device and FDA Regulations and Standards News 3
G Technical documentation for UKCA UK Medical Device Regulations 4
S Need clarification on UKCA and "Approved Body" UK Medical Device Regulations 7
G UKCA and EU MDR marking UK Medical Device Regulations 5
P Declaration of Conformity for UKCA UK Medical Device Regulations 14
H Brexit Regarding differentiation of CE & UKCA CE Marking (Conformité Européene) / CB Scheme 8
J UKCA direct marking implementation UK Medical Device Regulations 0
S Clinical trial requirements for UKCA mark in UK UK Medical Device Regulations 4
R CE and UKCA marking Own Brand products CE Marking (Conformité Européene) / CB Scheme 0
Q Is it worth already getting UKCA? UK Medical Device Regulations 2
D Correct form to amend medical devices class III (IMDRF vs Form 2016) Canada Medical Device Regulations 0
M UDI Suggestions for consumable devices US Medical Device Regulations 0
R Gibraltar refurbished medical devices UK Medical Device Regulations 1
L Use of Medical grade plastics in medical devices EU Medical Device Regulations 3
M Medical Devices Regulations and labelling requirements UAE Other Medical Device Regulations World-Wide 0
O Is a Certified 13485 for class I devices needed ISO 13485:2016 - Medical Device Quality Management Systems 2
dgrainger Informational MHRA Medical Devices Regulation Webinar - 24 January 2023, 10:00-11:30 GMT UK Medical Device Regulations 0
S Registation different version of Medical Devices & Germany competend authority EU Medical Device Regulations 3
drwallice Registration of medical devices EU Medical Device Regulations 2
K CE expiry and manufacturing devices CE Marking (Conformité Européene) / CB Scheme 3
M MDSAP Medical Devices Suppliers Canada Medical Device Regulations 5
C. Tejeda Process validation of rework assembly methods (medical devices) Medical Device and FDA Regulations and Standards News 3
E Device compatibility with other company's devices US Food and Drug Administration (FDA) 0
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
N FDA medical devices US Food and Drug Administration (FDA) 1
BusyBee GIVD codes for In-vitro medical devices EU Medical Device Regulations 2
J0anne How to find Certifying Bodies for US based & sold Medical Devices? US Medical Device Regulations 11
T PMCF Surveys for Class II a devices: basic requisites EU Medical Device Regulations 0
T PMCF Surveys for Class II a devices : basic requisites CE Marking (Conformité Européene) / CB Scheme 0
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
G Labeling requirements for REFURBISHED medical devices EU Medical Device Regulations 0
L Selling medical devices from USA in EU markets CE Marking (Conformité Européene) / CB Scheme 1
B "Old" devices - MDCG 2021-25 EU Medical Device Regulations 3
J IEC60601-1: HiPot Test Method for Internally Powered Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
C Regulatory requirements of cloud platform for devices developed in compliance with 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
H Active Implantable Medical Devices - ISO 14708 and EN 45502 Other Medical Device Related Standards 0
R EUDAMED - IVDD self-declared devices EU Medical Device Regulations 1
H Need guidance on importation of Custom-made devices into Japan Japan Medical Device Regulations 1
C Legacy device under Class A sterile devices EU Medical Device Regulations 0
N Exempted devices EU Medical Device Regulations 2
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
T Design Transfer & use of "prototype" components in production devices. ISO 13485:2016 - Medical Device Quality Management Systems 10
P Requirements for Exporting Medical Devices to Libya Other Medical Device Regulations World-Wide 2
T Peru Veterinary Medical Devices Other Medical Device Regulations World-Wide 0
CaliperJim Temperature and Humidity Effects on Measurement Devices General Measurement Device and Calibration Topics 6

Similar threads

Top Bottom