UKCA 最新情報

UKCA update blog

UKCA update blog

UKCAに関する最新情報をこちらでご紹介しています。

UKCAマークに関するサービスはこちら

医療機器のUKCAマークに関するサービスはこちら

 


 

UKCAマークの表示義務化が2024年末まで延長

2023年3月1日

英国向けのCEマークの使用期限は2022年12月31日まででしたが、2年間延長され2024年12月31日までになりました。 2025年1月1日以降はUKCAマークへの対応が必要となります。 

 

UCKAの導入プロセスでは、CEとUKCAの両方のマーキングに必要な基本的な要素について、一般的な理解が不足していることが明らかです。例として、市場監視当局が、AdCos(Administrative Cooperation Group)の傘下で毎年実施しているキャンペーンの結果をご紹介します。

国際的な無線機器指令(RED)の共同市場モニタリングキャンペーンで、2018年は5GHz帯のWLAN機器が対象に、そして2019年はモノのインターネット(IoT)が対象になりました。このモニタリングで、管理上の不適合があると判断された製造業者の割合はどの程度に上ったでしょうか?

結果、管理上の不適合があると判断された製造業者は、5GHz WLAN機器では全体の85%、IoT機器では72%に上りました(以下、ADCO REDの各レポートから引用)。

 

おそらく、これらの製造業者は皆、自分たちはすでに準拠している、これ以上やることはない、あるいは追いつくための時間は十分にある、と考えていたのではないでしょうか。英国におけるCEマーキングの受け入れが1年延長されたことで、移行プロセスを完了し、UKCAマーキングの準備をするために必要な時間が得られます。

 

テュフズードでは、お客様の移行をサポートするためのさまざまなサービスを提供しています。ぜひお気軽にお問い合わせください。

  • テクニカルファイルサマリーレビュー(非公式)
  • 英国適合性評価機関による公式テクニカルアセスメント:これには、ラベルのチェックも含まれます(上記「マーキング要件」を参照)
  • 適合宣言(DoC)レビュー
  • 標準版の違いに関するギャップ分析レポート

参照:
ADCO RED Report on 9th RED Market Surveillance Campaign on WLAN 5 GHz (rev 1) (performed in 2018)
ADCO RED Report on 10th RED Market Surveillance Campaign on IoT (performed in 2019)

 


 

英国CEマークの受け入れが1年間延期に

 

2021年8月24日

 

英国ビジネス・エネルギー・産業戦略省(BEIS)は、本日、英国におけるCEマーキングの受け入れを2023年1月1日まで延長することを発表しました。これにより、医療機器を除く、UKCAマーキングの対象となるすべての製品分野について、2023年1月1日までにUKCAマーキングを使用する準備を整える期間があることを意味します。

 

パンデミックが企業に影響を与え続けている中、今回の延長は多少の安心感を与えてくれますが、今回の延長は、企業がUKCAマーキングの実施に向けてまだ多くの準備をしなければならないことを浮き彫りにしており、企業にはできるだけ早く英国の新体制に対応することが望まれます。

 

注意すべき点は、英国市場でCEマーキングを継続して受け入れられるためには、EUと英国の要求事項が同じであることが必要で、EUと英国の要求事項の間に乖離がある場合にUKCAマーキングが必要になるということです。

 

この延期は、移行プロセスを完了するために必要な時間を提供します。テュフズードは、お客様の移行をサポートし、以下のようなUKAS認定のUKCA認証業務をスピーディーに提供することができ、その範囲は拡大しています。

  • 海洋機器規則(2016年)
  • 電磁両立性(EMC)規則(2016年)
  • 機械(安全)規制の供給(2008年)
  • 無線設備規則(2017年)

 

当社のEUノーティファイドボディおよびUK適合性評価機関としてのネットワークを生かし、テュフズードBABTは真にワンストップのCEおよびUKCAの試験・認証サービスを提供することができます。CEマーキングまたはUKCA以降のサポートが必要な場合は、ぜひ当社までお問い合わせください

View BEIS guidance

 


 

EU REGULATION 2019/1020 APPLIES IN NORTHERN IRELAND FROM 16 JULY 2021

 

14TH JUNE 2021

 

The UK Office for Product Safety & Standards (part of BEIS) have provided guidance on placing certain products on the Northern Ireland market. Article 4 of the EU Regulation on Market Surveillance and Compliance of Products requires that for certain products to be placed on the EU market, there must be an economic operator based in the EU responsible for compliance tasks. Otherwise these products cannot be placed on the EU market. For the duration of the Protocol, Article 4 applies to the NI market.

This guidance sets out how Article 4 applies to the NI market. There are various ways to meet the requirements of Article 4, and most UK businesses will likely have sufficient arrangements in place. If adjustments are needed, this guidance outlines what to do.

This guidance is particularly relevant to those who sell products online directly to consumers in NI (rather than via bricks and mortar shops).

 

Please find the government guidance text here:

 

EU Regulation on Market Surveillance and Compliance of Products (2019/1020)

 


 

RADIO EQUIPMENT REGULATIONS 2017 UPDATE - OFCOM LICENSE-EXEMPTION UPDATE

 

29TH APRIL 2021

 

Ofcom has today, 29th April 2021, confirmed changes to licence-exemption regulations for short range devices (SRDs).

 

Statement: Decision on changes to licence exemption for Wireless Telegraphy Devices and on licensing equipment in 57 to 71 GHz - Ofcom

 

KEY UPDATES

 

Wi-Fi & other Radio Local Area Network (RLAN) Technologies 6 GHz allocation: As expected, Ofcom are allocating an extra 500 MHz of spectrum from 5925 to 6425 MHz for Wi-Fi and RLAN devices and removing the Dynamic Frequency Selection (DFS) requirements in the 5.8 GHz band (5725 to 5850 MHz).

 

WBDTS 57 to 71 GHz band: Importantly, higher power wideband data transmission systems (WBDTS) in the 57 to 71 GHz band, from 20 May 2021 will now require a licence. For equipment already deployed under the existing licence-exemption framework Ofcom are providing a transition period where operators of the equipment will have until 30th November 2021 to obtain a licence.

 

There are also updates harmonising technical conditions for SRDs across several bands and the 870 to 874.4 MHz band.

 

From a legislation perspective this is enforced by the Wireless Telegraphy (Exemption) Regulations 2021 (the “Exemption Regulations”)) UK SI. 2021:493 which comes into force on 12th May 2021.

 

The Wireless Telegraphy (Exemption) Regulations 2021 (legislation.gov.uk)

 

This is an important indication of where UK requirements may have the possibility of diversification from Europe. An update to Ofcom IR 2030 Licence Exempt Short Range Devices is expected to be publicly released shortly reflecting these changes.

 


 

UPDATED GUIDANCE - USING THE UKCA & UKNI MARKING

 

22ND FEBRUARY 2021

 

UKCAロゴ 

 

Government guidance on using the UKCA & UKNI mark has recently been updated, specifically guidance on the UKCA & UKNI logo when placing either product marking on your product, packaging or support literature. As a result, the UKCA & UKNI marks must be a minimum of 5mm in height for the whole product marking, not just the individual letters (unless applicable legislation states otherwise).

Please find the updated government guidance text on this here:

 

Using the UKCA marking

 

Using the UKNI marking

 


 

SPECIFIC PRODUCT SAFETY AND METROLOGY REGULATIONS GUIDES UPDATED

 

1ST FEBRUARY 2021

 

The UK Office for Product Safety & Standards (part of BEIS) has updated the guides on specific product safety and metrology regulations for businesses placing goods on the market in Great Britain from 1st January 2021.

 

The original links will now take you to an industry guidance page rather than the individual guides. For links to the applicable product safety guides please see below:

 

General product safety law
General Product Safety Regulations 2005

 

ATEX
Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016

 

Electrical and electronic
Electrical Equipment (Safety) Regulations 2016
Electromagnetic Compatibility Regulations 2016
Radio Equipment Regulations 2017

 

Gas appliances
Regulation 2016/426 and the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018

 

Lifts
Lifts Regulations 2016

 

Machinery
Supply of Machinery (Safety) Regulations 2008

 

Personal protective equipment
Personal Protective Equipment (Enforcement) Regulations 2018

 

Pressure equipment
Pressure Equipment (Safety) Regulations 2016

 

Recreational craft
Recreational Craft Regulations 2017

 

Toys
Toys (Safety) Regulations 2011

 

There are currently no guidance documents available for weights and measures regulations.

 


 

RADIO EQUIPMENT DESIGNATED STANDARD LIST RELEASED

 

23RD DECEMBER 2020

 

The designated standards for the Radio Equipment Regulations 2017 (S.I. 2017/1206) have now been released.

 

Radio Equipment Designated Standards

 


 

RADIO EQUIPMENT REGULATIONS 2017 RESTRICTED PRODUCT UPDATE

 

22ND DECEMBER 2020

 

Radio equipment that have restrictions on use in the EU need to comply with the Radio Equipment Directive 2014/53/EU Article 10(10) requirements and include a pictogram on the packaging artwork and an explanation in the user manual. There was a potential conflict when the EU were stating that “UK” should be removed and UK(NI) added, but the UK-EU exit amending regulations implementing this for UK regulations stated that “UK” was required with the pictogram.

These contradictory requirements have now been resolved with updated UK guidance which states:

"Therefore, use of either “UK” or “UK(NI)” is acceptable for the GB market and products where Regulation 14 requirements are met with “UK” will continue to be accepted in GB, as will products with both “UK” and “UK(NI)”.

 

Radio Equipment Regulations 2017 Guidance on Regulation 14

 


 

TÜV SÜD BABT HAS BEEN ACCREDITED BY UKAS AND APPOINTED AS A UK MARKET CONFORMITY ASSESSMENT BODY

 

18TH DECEMBER 2020

 

TÜV SÜD is pleased to announce that its accreditation body, TÜV SÜD BABT, has now been accredited by UKAS and appointed as a UK Market Conformity Assessment Body (UK Approved Body) by the UK Department for Businesses, Energy & Industrial Strategy. This means from the 1st January 2021 in-line with current legislation, TUV SUD BABT will commence it’s certification offering of the UKCA mark and the UK Marine mark for the Great Britain market as well as the CE + UKNI mark for the Northern Ireland market as required.

 

TÜV SÜD BABT’s UKAS accreditation scope includes the following:

 

  • UK Marine Equipment Regulations 2016
  • Electromagnetic Compatibility Regulations 2016
  • Supply of Machinery (Safety) Regulations 2008
  • Radio Equipment Regulations 2017

 

TÜV SÜD BABT’s UKAS scope of accreditation will shortly be extended and will commence its certification offering of:

 

  • The Equipment and Protective Systems intended for Use in Potentially Explosive Atmospheres Regulations (ATEX) 2016
  • Personal Protective Equipment Regulations 2018

 

UK Market Conformity Assessment Bodies (TÜV SÜD BABT)

TÜV SÜD BABT’s Certification Body Manager, Nathan Emery said, “TÜV SÜD are happy to announce receiving the scope of accreditation from UKAS to enable the issuance of UK Approved Body Certification for products being placed onto the market in the United Kingdom and EU Notified Body Certification for products being placed onto the market in Northern Ireland. This matched with the continuation of being an EU Notified Body for issuing certification for products being placed onto the market in the European union gives a full range of support for current and potential clients with their European regulatory needs”.

If you have any questions about TÜV SÜD BABT’s appointment as a UK Approved Body and UN Notified Body please contact us.

 


 

PREPARE FOR THE NEW UKCA RULES COMING INTO EFFECT FROM 1 JANUARY 2021

 

17TH DECEMBER 2020

 

At the time of writing, with discussions still on-going, time is running out to reach a Trade Agreement before the end of the Brexit Transition Period on 31 December 2020. The delay in concluding a trade deal has created more uncertainty, not only with businesses in the United Kingdom and European Union, but also those businesses around the world who wish to place products on the UK market from 1 January 2021.

However, with the introduction of the new UKCA mark, no matter whether or not a deal is reached between the United Kingdom and European Union, the product safety rules coming into force from the 1st January 2021 have already been put in place. The UKCA Mark will be replacing the CE mark in Great Britain, with new UKNI mark for the Northern Ireland market.

If you have not yet begun preparing for the introduction of the new UKCA mark (as well as the new UKNI mark), now is the time to see what changes you need to make from the 1st January 2021 or beyond.

We will be keeping you up to date with the outcome of the trade talks and any other news over the Christmas period on our UKCA blog.

If you have any questions, please send them through to our UKCA Mailbox – [email protected]

 


 

METROLOGY SERIES EU EXIT UK STATUTORY INSTRUMENT AMENDMENTS

 

10TH DECEMBER 2020

 

UK Statutory Instrument 2020 No. 1460  “The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020” has now been “Made”. This is a significant update completing the metrology series EU Exit UK Statutory Instrument amendments. As well as detailing the UKNI marking requirements this amendment also has further amendments to the “mega SI” 2019 No. 696 including legal implementation of the most recent guidance from the UK government about for example acceptance of CE marking in the UK for 12 months after IP completion day. This SI also clarifies that that from IP completion day authorised representatives must be based in the United Kingdom, with respect to any products placed on the market of Great Britain.

 

View UK Statutory Instrument 2020 No.1460

 


 

DESIGNATED STANDARDS UPDATE LIST RELEASED

 

9TH DECEMBER 2020

 

The UK government has now released a further update to the designated standards lists for ATEX, cosmetic products, EMC, explosives for civil uses, gas appliances, lifts, low voltage equipment, machinery, measuring instruments, NAWI, PPE, pressure equipment, pyrotechnic articles, recreational craft, RoHS, simple pressure vessels and toy safety. The designated standards list for Radio Equipment has not currently been released to date.

 

View Government guidance

 


 

DESIGNATED STANDARDS GUIDANCE RELEASED

 

1ST DECEMBER 2020

 

With 25 days to go the UK government has released guidance for the UK designated standards list. It has been confirmed that the UK designated standard list will be published by GOV.UK and will follow the EU official journal harmonised standards providing presumption of conformity with GB law.

 

Designated standards will be prefixed “BS”, “EN”, “EN ISO” or “EN IEC” as they are in the EU official journal from all the current standards bodies (i.e. BSI, CENELEC, ETSI, ISO etc)

 

View designated standards guidance

 


 

NORTHERN IRELAND SPECIFIC PRODUCT SAFETY AND METROLOGY REGULATIONS GUIDES RELEASED

 

1ST DECEMBER 2020

 

Following our recent blog post for GB guidance documents, guides on specific product safety and metrology regulations for businesses placing goods on the market in Northern Ireland from 1 January 2021 are now available for most categories. This includes newly released guidance for placing radio equipment goods on the Northern Ireland market.

 

General product safety law (NI)
General Product Safety Regulations 2005

 

Cosmetics (NI)
Regulation 2009/1223 and the Cosmetic Products Enforcement Regulations 2013

Electrical and electronic (NI)
Electrical Equipment (Safety) Regulations 2016
Electromagnetic Compatibility Regulations 2016
Radio Equipment Regulations 2017

Fireworks (NI)
Pyrotechnic Articles (Safety) Regulations 2015

Gas appliances (NI)
Regulation 2016/426 and the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018

Lifts (NI)
Lifts Regulations 2016

Machinery (NI)
Supply of Machinery (Safety) Regulations 2008

Metrology (weights and measures) (NI)
Measuring Instruments Regulations 2016
Non-Automatic Weighing Instruments Regulations 2016

Outdoor equipment (NI)
Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001

Personal protective equipment (NI)
Regulation 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018

Pressure equipment (NI)
Pressure Equipment (Safety) Regulations 2016
Simple Pressure Vessels (Safety) Regulations 2016

Recreational craft (NI)
Recreational Craft Regulations 2017

Toys (NI)
Toys (Safety) Regulations 2011

 


 

SPECIFIC PRODUCT SAFETY AND METROLOGY REGULATIONS GUIDES RELEASED

 

18TH NOVEMBER 2020

 

The UK Office for Product Safety & Standards (part of BEIS) has released guides on specific product safety and metrology regulations for businesses placing goods on the market in Great Britain from 1st January 2021.

These guides apply from 1st January 2021 and contain very useful guidance on the obligations of manufacturers, authorised representatives, importers and distributors, providing further guidance for transitional arrangements and UKCA marking.

 

General product safety law
General Product Safety Regulations 2005

 

ATEX
Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016

 

Electrical and electronic
Electrical Equipment (Safety) Regulations 2016
Electromagnetic Compatibility Regulations 2016
Radio Equipment Regulations 2017

 

Gas appliances
Regulation 2016/426 and the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018

 

Lifts
Lifts Regulations 2016

 

Pressure equipment
Pressure Equipment (Safety) Regulations 2016

 

Recreational craft
Recreational Craft Regulations 2017

 

Toys
Toys (Safety) Regulations 2011

 

There are currently no guidance documents available for PPE, machinery or weights and measures regulations.

 


 

UK MARINE EQUIPMENT CONFORMITY ASSESSMENT MARK RELEASED

 

16TH NOVEMBER 2020

 

The UK Maritime & Coastguard Agency (MCA) has now released to Notified Bodies the UK Marine Equipment Conformity Assessment Mark Logos in all suitable formats and released UK guide templates for Marine UK Module B and Module D-E-F-G certificates so that we can finalise our UK Marine Equipment Conformity Assessment documentation.

Quote from the UK MCA:

 

"This update reflects the UK Marine Equipment conformity assessment certificate templates to be used from January 1st 2021. To note that the Marine Equipment UK conformity mark (Red Ensign Mark) is only to be used on marine equipment that is in compliance with the UK Regulations which will only come into effect on January 1st 2021."

 


 

USING THE UKNI MARKING FROM 1 JANUARY 2021

 

5TH NOVEMBER 2020

 

Due to the Northern Ireland Protocol, the UK government has now released guidance on the requirements for UKNI marking and when it is required. In most cases marking requirements will be satisfied by combined CE and UKCA marking on a product which needs to be placed on the Great Britain, European and Northern Ireland markets.

UKCAチャート  

 

View Government guidance

 


 

ECODESIGN AND ENERGY LABELING UPDATE

 

29TH OCTOBER 2020

 

Ecodesign and Energy Labeling rules are changing from 1st January 2021. All new products being placed on the GB market from 2021 will need to include the new UK branded flag energy label.

 

Here is a summary of the new rules for GB (Excluding NI):

 

  • This will apply to all products that fall under the existing EU Ecodesign and Energy Label rules
  • All new products being placed on the GB market from 1st January 2021 will need a UK branded Energy Label and have English text
  • The product should also include a QR code linked to a publicly accessible website
  • Products already on the market before 1st January 2021 can continue to use the existing EU labeling until the end of the transition period. This includes products already manufactured and in a warehouse waiting to be shipped at 1 January 2021
  • After 1 January 2021, products placed on the GB market only will not need to enter the information on the EU product database (EPREL)
  • The Department for Business, Energy and Industrial Strategy (BEIS) has produced a UK energy label generator for products

 

View BEIS UK energy label generator

 

For products being placed on the market in Northern Ireland (NI), existing EU legislation and labeling rules will continue to apply, including EU branding and use of the EPREL database.

 


 

NORTHERN IRELAND UPDATE

 

15TH OCTOBER 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

 

12TH OCTOBER 2020

 

In September 2020, the UK government set a deadline of the 15th October 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”.

 

 

 

With the future relationship between the UK and the EU set to be potentially clearer in the coming days, TUV SUD 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 COASTGUARD AGENCY RELEASE

 

6TH OCTOBER 2020

 

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 1 January 2023. However, as with the CE marking guidance, this extension is subject to continued alignment of the EU and UK standards requirements.

 

From the 1st Jan 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

 

24TH SEPTEMBER 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

 

17 SEPTEMBER 2020

 

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

 

8 SEPTEMBER 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 1 January 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 (30 April 2021)
  • 8 months: Class IIb (non-implantable), Class IIa, IVD List B, Self-test IVDs (31 August 2021)
  • 12 months: Class I devices, general IVDs (31 December 2021) – not applicable for devices already registered

 

  • CE marking will be recognised in Great Britain (England, Scotland and Wales) until 30 June 2023. In Northern Ireland, the CE mark will continue to be allowed after 30 June 2023
  • From 1 July 2023 – UKCA requirements will apply in full in GB
  • UKCA mark will not be recognised 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 1 January 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 1/9/20

 

1 SEPTEMBER 2020

 

This latest guidance explains how to use the UKCA marking. The new UKCA mark can be used on all new products from the 1st January 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 1st January 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 1st January 2021, including (where applicable) engaging the services of a UK-recognised 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 recognised in the EU market.
If all these apply to you then you must be using the UKCA marking by the 1st January 2021. If your product:

 

  • Is for the market in GB
  • 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 recognised body before the 1st January 2021

 

View guidance document

 


 

WHAT DOES ONE OF THE MOST RECENT EU EXIT METROLOGY UK SI DO?

 

28 AUGUST 2020

 

UKSI 0852There 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 2nd July 2020 and 40 days later was ‘Laid’ to Parliament on the 12th August via the negative shifting process.

 

View UK Statutory Instrument 2020 No.852

 


 

LATEST UKCA WEBINAR NOW AVAILABLE ON DEMAND

 

27 AUGUST 2020

 

The UKCA Webinar, hosted on the 26th August 2020 by TUV SUD, 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

 

次のステップ

Site Selector