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UKCA Mark Update Blog

Bringing you the latest updates and insights

Here you’ll find the blog posts providing insights and the latest government updates on the ever evolving subject of UKCA marking.

Find more information on our UKCA mark webpage


Northern Ireland Update

October 15, 2020

There has been a further metrology UK Statutory Instrument series amendment which was laid before Parliament at 2.00 p.m. on 13th October 2020 specifically for Northern Ireland requirements. The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 also comes into force on IP Completion day. This update has specific requirements for the metrology UK regulations for Northern Ireland only, as required by the special situation under the Northern Ireland Protocol. The main metrology amending Statutory Instrument 2019/696 should still be considered, but now only for England, Wales and Scotland.

Since this is a very significant update TÜV SÜD will be releasing updated guidance for this shortly.

View UK Statutory Instrument 2020 No.1112


Free Trade Deal Deadline Approaching

October 12, 2020

In September 2020, the UK government set a deadline of the October 15, 2020 for a free-trade deal with the European Union to be agreed. With that deadline rapidly approaching in just three days, the UK and the EU are approaching the end of the Brexit negotiation discussions making the next week crucial in whether the UK leaves with an agreement or leaves with a “no deal”.

UKCA Mark Deadline Timeline

With the future relationship between the UK and the EU set to be potentially clearer in the coming days, TÜV SÜD is committed to keeping our customers up to date on the very latest news relating to the new UKCA mark and the wider topic of Brexit to ensure our customers are fully informed on the forthcoming changes that affect you.

We will be providing updates through the UKCA blog to keep you up to date with the latest news during this crucial week of UK-EU discussions.


Latest UK Maritime and Coast Guard Agency Release

October 6, 2020Marine Information Note MIN 590 Issue 3

The UK Maritime and Coastguard Agency has just released Marine Information Note document MIN 590 Issue 3 for UK conformity assessment procedures for marine equipment following the transition period.

This updated guidance allows EU Marine Equipment Directive approved equipment to continue to be placed on UK ships until January 1, 2023. However, as with the CE marking guidance, this extension is subject to continued alignment of the EU and UK standards requirements.

From the January 1, 2021 Marine Equipment holding UK Conformity approval granted by a UK Approved Body with a UK Conformity mark can be placed on board UK ships. As highlighted in MIN 590 Issue 3, “Businesses are encouraged to be ready for full implementation of the new UK regime as soon as possible after the transition period ends.”

View Marine Information Note MIN 590 Issue 3


LESS THAN 100 DAYS TO GO

SEPTEMBER 24, 2020

In a statement made to the House of Commons on Wednesday 23rd September Michael Gove, the Chancellor of the Duchy of Lancaster, highlighted that ‘there are now just 100 days to go until the United Kingdom leaves the Single Market and the Customs Union’.

The end of the transition period brings with it a lot of opportunity but as Gove points out in his statement many business are not fully prepared and many still believe that the transition period will be extended.

Read Full Statement


Significant Update for Marine Equipment Manufacturers

September 17, 2020UK Statutory Instrument 2020 No.1000

The government has released a new Statutory Instrument, UK SI 2020/1000, providing new guidance on exiting the European Union for Merchant Shipping. The Merchant Shipping (Consequential Amendments) (EU Exit) Regulations 2020, was Laid before Parliament on the 16th September 2020.

This new SI indicates that, similar to the UK SI 2020/852 update for the ‘mega SI’ amendments, a significant number of Marine EU Exit amendments have been amended to come into force “immediately before IP completion day”.

Importantly for Marine Equipment manufacturers this means that The Merchant Shipping (Marine Equipment) (Amendment etc.) (EU Exit) Regulations 2019 (UK SI 2019/470) which, for example, specifies the UK Marking and UK Declaration of Conformity requirements for Marine Equipment, would now come into force on IP completion day.

The Maritime & Coastguard Agency (MCA) will be providing updated guidance in the near future and TÜV SÜD will supply links to this information when it is released.

View UK Statutory Instrument 2020 No.1000


CURRENT UK GOVERNMENT GUIDANCE FOR MEDICAL DEVICES

SEPTEMBER 8, 2020

Following on from the latest UK Government update, we are able to offer an insight into the current guidance for medical devices. After the transition period the guidance for medical devices deviates from the general UKCA guidance. Some of the main points are as follows:

  • All medical devices, in vitro diagnostic devices (IVD), and custom-made devices must be registered with the MHRA from January 1, 2021.
  • There is a grace period for manufacturers to register their devices with MHRA:
    • 4 months: Class III and Class IIb implantable, IVD List A (April 30, 2021)
    • 8 months: Class IIb (non-implantable), Class IIa, IVD List B, Self-test IVDs (August 31, 2021)
    • 12 months: Class I devices, general IVDs (December 31, 2021) – not applicable for devices already registered
  • CE marking will be recognized in Great Britain (England, Scotland and Wales) until 30 June 2023. In Northern Ireland, the CE mark will continue to be allowed after June 30, 2023
  • From July 1, 2023 – UKCA requirements will apply in full in GB
  • UKCA mark will not be recognized in EU, EEA or Northern Ireland
  • For Northern Ireland, either the CE mark or dual UK(NI) CE mark will be required
  • UK Responsible Person will be required if the manufacturer is located outside the UK
  • UK Approved Bodies will be designated from January 1, 2021
  • Following approval from a UK Approved Body, a manufacturer will be able to affix the UKCA mark (in Great Britain), or UK(NI) mark (in Northern Ireland)
  • These new transitional periods will need to be supported by updated UK legislation and TÜV SÜD will provide additional information on these requirements when they are released.

Read guidance for medical devices


LATEST GOVENMENT GUIDANCE 9/1/20

SEPTEMBER 1, 2020

This latest guidance explains how to use the UKCA marking. The new UKCA mark can be used on all new products from January 1, 2021.  However, this update from the government states that to make sure businesses have time to adjust to these new requirements, you will still be allowed to use CE marking until January 1, 2022 in most cases. This transitional arrangement will require additional legislation via a new UK Statutory Instrument. The guidance is clear that this is strictly a temporary arrangement and businesses will be actively encouraged to be ready for full implementation of the new UK regime as soon as possible after January 1, 2021, including (where applicable) engaging the services of a UK-recognized approved body.

The CE marking will only be valid in Great Britain where the rules in the EU are the same as the UK. The UKCA marking will not be recognized in the EU market.

If all these apply to you, then you must be using the UKCA marking by January 1, 2021. If your product:

  • Is for the GB market
  • Is covered by legislation which requires the UKCA marking
  • Requires mandatory third-party conformity assessment
  • Conformity assessment has been carried out a UK Conformity Assessment Body and you haven’t transferred your conformity assessment files from you UK body to an EU recognized body before January 2021

View guidance document


What Does one of the Most Recent EU Exit Metrology UK SI Do?

August 28, 2020UKSI 0852

There are plenty of points to talk about when it comes to the topic of the UK Statutory Instrument 2020 No.852, for one this amends the UK SI 2019 No,696. This does raise an important point, we have to be careful with SI titles, in this instance the SI refers to ‘The Product Safety and Metrology Amendment’ when actually this is amending a whole series of other schedules in UK SI No.696.

The key amendment that stands out from the rest is that it changes the enforcement day from ‘Exit Day’ to ‘IP Completion Day.’

People are expecting further UK SI ‘EU Exit’ amendments on the metrology series of SI, we will provide information on these updates as and when they come through.

As a prime example of just how fast statutory instruments can go through, the UK SI was drafted on the July 2, 2020 and 40 days later was ‘Laid’ to Parliament on August 12th via the negative shifting process.

View UK Statutory Instrument 2020 No.852


LATEST UKCA WEBINAR NOW AVAILABLE ON DEMAND

AUGUST 27, 2020

The UKCA Webinar, hosted on the August 26, 2020 by TÜV SÜD, is now available for all to watch on demand. We thank those who attended and we are delighted with the great success of the event.

This is the first of a series of webinars on the UKCA marking that will be provided across the months leading up to the transition deadline.

The webinar covers everything you need to know about the transition from one mark to another and what that means for you, a handful of topics being; what to expect from the new UKCA mark, the transition from the CE mark to the UKCA mark, we go deeply into detail on statutory instruments, we include information on what different fields of work have to do in preparation for IP Completion Day and what to expect.

Click here to watch

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