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BREXIT and CE Marking ???  

"Prediction is very difficult, especially if it's about the future."    - Nils Bohr

BREXIT and CE Marking - Questions and "Answers"  

BREXIT "UPDATE": 10th February 2020

As of 11:00 pm 31st January 2020, the UK has officially left the EU... however basically for the rest of the year (as least) there is no change when it comes to the Product Regulatory situation.  A majority of Manufacturers are hoping that the status quo will be maintained indefinitely, but that has , as yet , not been decided. Hopefully this will be clarified in the coming months... we'll try and keep you informed.

 

 

 

 

 

BREXIT "UPDATE": 13th December 2019

 

Following the election result it would appear the initial withdrawal from the EU is about to happens.  When it does, fortunately the situation relating to product regulatory issues is clear, basically no change!  This will remain the same at least until December 2020... what happens after that date it yet to be determined. When we know , we'll let you know!

 

BREXIT "UPDATE": 3rd June 2019

 

The uncertainty surrounding the UK (potential) exit from the European Union continues to permeate all aspects of life. Fortunately at present the situation relating to product regulatory issues is clear, basically no change!  This will remain the same at least until 31st October 2019... what happens after that date ????  When we know , we;ll let you know!

There has be a some of talk and little contingency information  concerning what would happen in the event of a "no deal" scenario,  ("UK Marking" in addition to "CE Marking" etc.), but in reality none of this has reached a stage where it is sensible (or even possible) to plan for the event. In reality under any conceivable situation the actual product requirements are very unlikely to change , although there could be significant "administrative" changes. These would affect any products that require Notified Body involvement, but could also affect other "self-declared" products .

 

BREXIT UPDATE:  10th July 2019

Chequers Statement 6th July 2018 (... may be subject to change!) 

4. The Government will publish a White Paper setting out this proposal in detail next week, but in summary we agreed its four main elements.

a. The UK and the EU would maintain a common rulebook for all goods including agri-food, with the UK making an upfront choice to commit by treaty to ongoing harmonisation with EU rules on goods, covering only those necessary to provide for frictionless trade at the border. These rules are relatively stable, and supported by a large share of our manufacturing businesses. The UK would of course continue to play a strong role in shaping the international standards that underpin them, and Parliament would have oversight of the incorporation of these rules into the UK’s legal order – with the ability to choose not to do so, recognising that this would have consequences. We would strike different arrangements for services, where it is in our interests to have regulatory flexibility, recognising the UK and the EU will not have current levels of access to each other’s markets.

...  this means that (if agreed)  for "Products"  there should be no change in the foreseeable future.

BREXIT UPDATE: February 2018

 

A (very) brief document titled "Notice to Stakeholders WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF INDUSTRIAL PRODUCTS"  was released by the European Commission on 22nd January 2018, the first of many no doubt.....  click here to read it 

 

BREXIT UPDATE: 8th December 2017  - SOME PROGRESS!

 

The Joint Report  (TF50 (2017) 19) covering the first stage of the UK's "disengagement" from the EU has now been issed , it obviously covers a lot of ground, but the important part from the point-of-view of CE Marking is Aricle 90 on page 14 (of 15) which reads, 

90. On ensuring continuity in the availability of goods placed on the market under Union law before withdrawal both Parties recognise the need to provide legal certainty and minimise disruption to business and consumers. Both Parties have agreed the principles that the goods placed on the market under Union law before withdrawal may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight. 

In a nutshell this means nothing changes... at least up until "withdrawal" (the "withdrawal date" is actually unclear from the communications and might vary depending on the area of interest). What happens afterwards is unclear and obviously there will be a lot of detailed legislation required to implement anything. We'll keep you informed as we hear.

Dr Colin R Petts   Original 27th June 2016, Updated 7th September 2016

Following the result of the referendum, every aspect of our (the UK) world appears to be in turmoil, and as a result almost everything that can be said is conjecture and should come with the standard financial warning that "predictions can go down as well as up".

If you've arrived at this web page then you're interested in how the coming changes in the status of the UK will affect the requirements for CE marking, indeed you're probably asking whether its needed at all,  if you only trade within the UK... I will restrict my musings to CE Marking and related issues (such as EN standards) and given below are some of my initial thoughts based on an engineer/scientist's pragmatism ... which obviously can be overturned by politicians and lawyers! 

24th June 2016 - > 2 years after Article 50 is triggered (?) :  No change

The surprise result on Friday 24th 2016 affected many things very quickly, the Pound, share prices, the PM, the shadow cabinet etc. What it didn't do was actually change any laws or actually our status within the EU. As a result all previous requirements for CE marking of products remain unchanged, if a product needed CE Marking on 23rd June, it still does and will do for the foreseeable future. Products sold solely in the UK still need CE marking (where appropriate) and those exported to other EU members also need it.

 

Since there are many more pressing things to be sorted out in the 2 years after Article 50 is triggered, it is my gut feel that most of the technical stuff associated with product compliance will be put on something of a back-burner hence the >>2 years.... and might never actually change.

 

After the "Degree Absolute"

It is conceivable (likely?) that there will be some form of deal on product regulations that mean we'll carry on CE marking as before like the EFTA countries (Iceland, Norway and Liechtenstein) or like Switzerland and Turkey which would mean that for a vast majority of products there would be no change in the future.

 

If however there was a complete break, it is my opinion that since the UK has always been a significant force behind the adoption of the (Product) CE marking directives, it is highly unlikely that the detailed (Essential) requirements given in the EU Directives and taken into UK law via Statutory Instruments will change after the UK (or parts of it!) officially leave the EU.

 

There would be "administrative" differences, for example the actual marking may/would change and for some directives there would be a requirement for EU-based Authorized Representative to be appointed. The biggest change would be those products requiring the involvement of a Notified Body, manufacturers would find that they  have to change bodies to one based in the EU (since "Notified Body" is really an EU idea), although I'm sure the current NBs will figure out a way through this.   

European Standards

The normal approach to demonstrating compliance with the various directives is to assess the product with respect to Euro-Normalized standards that are cited within the Official Journal and provide a "presumption of conformity", so what will/might change?  The simple answer is not a lot.  The United Kingdom is a full member of the European Committee for Standardization (CEN) and adopts Euro-normalized standards as National standards (EN become BS EN), leaving the EU won't affect that process since its completely independent.

 

Directives are different from Standards!

 

I've heard it said recently (even by Organizations that should know better!) that since the standards are unlikely to change there's nothing to discuss/worry about... that is so wrong!  EU Directives (and Regulations) relating to CE marking of products are instruction from the EU to the member states to put onto their own statute books laws that make all of the applicable "Essential Requirements" mandatory, i.e. once "on the books" compliance is the law.  When a particular standard is cited in the Official Journal of a particular directive it become a meansof  demonstrating that the product complies (gives a "Presumption of Conformity" ) and is often used as support information in the "technical file" for the product.... however it is important to realise that this is NOT the only way to demonstrate compliance, you can CED Mark a product by complying with the Essential Requirements alone without once referring to a standard!  indeed, although standards are regarded as "best practice they have no "legal status" as such,  and include statements like " Compliance with a Standard cannot confer immunity from legal obligations."

 

There are a number of reasons why this distinction is important.  For example some years down the line there may be the situation where a product that is being imported into the post-BREXIT UK, legitimately bears the CE marking but includes no reference to EN standards, if the UK only recognizes standards presumably that product would not be accepted without further testing/assessment.   Also, since the standards don't necessarily cover everything required by the Directives/Regulations, the situation could arise where a UK product that complies with a suitable EN standard doesn't comply with all of the CE marking requirements because some change may have occurred in the current version that's not in the UK Statutory Instrument.  Obviously this could be addressed by the exporter ... with help from us!  but it would be so much better if there were no differences anyway.

Some BREXIT Questions and "Answers"

 

Given below are a number questions that we have been asked since the Referendum results were declared, together with the best "Answer" that we have been able to give at this stage. These answers are based on "Engineering Pragmatism" ... hence may be overturned by Political Expediency! These questions are only one-line summaries of more detailed discussions, if you have a particular query please feel free to call us to us and we'll try and help (contact us).

Note: The below summary is provided for guidance purposes only and does not constitute advice. The details of the actual directives and applicable conformity processes should be reviewed and used for all business, legal, and product compliance purposes.

 

What complications do you forsee post BREXIT if things aren't sorted sensibly ? (21/09/16)  - There are many things that could get complicated... one simple example is that when the UK is out of the EU, English may no longer be an "Official Language" and hence all Technical Documentation relating to CE marking might have to be presented in another language!  This would also cause difficulties for English speaking countries such as USA and Australia... the thing is that life could be very difficult if the negotiations are done badly, one can only hope before deciding upon anything, a suitable level of consultation with people in the know (i.e. people that actually work with the requirements) will take place.  At this stage the only sensible advice to give is .... DON'T PANIC, but keep your eyes and ears open. So far there has been no official statements on this ... or just about anything! 

 

We're a non-EU manufacturer based in the US and sell a product that falls under the EMC directive (only) , we currently have an Authorized Representative in the UK who also act as an Agent and we're happy with them. We've been approaches by an Organization in Holland who say we need to get a non-UK Authorized Representaive now and have offered us a deal, should we take it? (06/09/16)  - We have heard that a number of ... shall we say "less scrupulous" organizations have been targeting non-EU manufacturers saying they need to switch now to ensure compliance... its just not true! In your case you do need an Authorized Representative since you've not had a Notified Body check the EMC assessment, but if your happy with the current guys, stay with them. There is no change at present and won't be for more than 2 years, it may be that the UK will be "accepted" in future anyway. Don't be pressurized!

 

We're UK based, do I need to sort out an Authorized Representative in the EU ? (06/09/16)  - At present whether a non-EU based manufacturer requires and "EU Authorized Representative" depends on the detail of the directives involved (i.e. LVD - No,  Medical - Yes etc.). Irrespective of that , at present there is no change, so you don't need to sort one out now even if the directive involved requires it for non-EU manufacturers. We would also advise waiting since there may be a deal done to accept UK based manufacturers (mutual recognition) ... at this stage its unknown so don't jump the gun!

 

What has been said officially about all of this by the government, HSE etc ? (12/07/16)       - We haven't heard anything about this at all.  All of the comments made so far are by people like ourselves, hopefully realistic but nothing "official".

 

What about all of the EN standards will we have to revert to BS standards ? (12/07/16) -   The European organization that sorts out the standards (CEN) is not part of the EU. BSI who issue the standards in the UK is a member of CEN and one of the requirements of membership is to remove "national" standards that conflict with CEN standards.  Hence exiting from the EU would not change the standards that are currently used.

If we leave the EU but still want to sell CE Marked product into it, will we need EU Authorized Representatives? (01/07/16) -   Here the answer is a little complex since it depends on the directives that apply. For example if a product only falls under the Low Voltage Directive, a non-EU manufacturer can CE mark their own product with no other involvement, whereas all Medical Devices require a Authorized Representative.... there are others where "it depends".

We sell Class IIa Medical Devices and hence have a UK Notified Body involved, is this ok now and going forward? (30/06/16) -   At present there is no change, UK Notified Bodies will continue to maintain their status at least until the UK exit. Following the exit the situation becomes more complex (since Notified Bodies are generally expected to be EU-based). It is likely that either they will continue to be accepted as part of the divorce deal, or the UK sections will operate under "control" from EU based parts of the Organization, this is similar to the way in which the assessment bodies operate elsewhere in the world.

 

Note:  The above answer would also be valid for other products that require the involvement of a Notified body (i.e. Atex, Annex IV Machinery etc).

 

When we exit from the EU, will CE marking still be valid? (27/06/16) -   Its impossible to say 100%, but generally the CE marking approach/process is based on what the UK regarded as best practice and hence we would expect that for the foreseeable future the basic approach will be continued. There are however some detailed things that might change, particularly when third party (Notified Bodies) are involved, also when directives change, it may be that the SI will not reflect the most recent version of the Essential Requirements given in the directive.

We sell a product (only in the UK) that should be CE marked, but we've not got around to it, can we now delay doing anything until things are sorted out? (27/06/16) -   The simple answer is NO, for products tha fall within the scope of the directives, CE marking is (and remains) mandatory. The directives were transcribed into UK Statutory Instruments (Laws) and hence need to be implemented, if you continue to do nothing then you continue to be exposed legally.

 

At this moment,  is CE marking required in the UK?  (24/06/16) -   The simple answer is YES , if it applied to the product prior to 23rd June, it still applies within the whole of the EU , including the UK.

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Statement: Petts Consulting Ltd will provide an Organization with the knowledge of the Directives and an appropriate process which, when applied correctly will demonstrate due-diligence. However, the CE-marking is the manufacturers claim that the product meets the essential requirements of all relevant European Directives. In many cases the process to be carried out is a self-declaration process and the responsibility for any decisions lie with the management of the Company. During the course of the project Petts Consulting Limited will provide guidance and advice but ultimately it cannot be held responsible for such decisions.