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Are you ready for RED?

The new CE Marking directive covering ‘Radio Equipment’ came into force on 13th June 2016.  To assist manufacturers and other economic operators adjust to the new Legislation, the Radio Equipment Directive (RED) 2014/53/EU featured a transitionary period of 1 year during which time it has been permissible to declare conformance to the old R&TTE Directive. However, from 13th June 2017 any product containing a radio transmitter or receiver (within scope of the RED) will need to conform to the new Directive.

Most companies would want to follow the self-assessment route to conformity, but there has been a difficulty in that most of the harmonised standards needed to demonstrate conformity have not been published on the EU Official Journal. Up until recently, this has meant that the only route to conformity for the radio parts of a product was to engage a Notified Body.

However, over the last few months a number of standards have been added to the Official Journal. For example a number of standards have been added for Short Range Devices (SRD) such as ETSI EN 300 220-2 V3.1.1 which covers 25 MHz to 1000 MHz for non-specific radio equipment. Also on the list are ETSI EN 300 330 V2.1.1 and ETSI EN 302 208 V3.1.1 whose scopes cover some RFID devices.

If you have been waiting for standards to become available now is the time to see if you can update your conformity. First assess which category in the list of Class 1 sub-classes your product falls under: http://ec.europa.eu/DocsRoom/documents/7981/attachments/1/translations

The sub-class details will give the ETSI standard that covers the sub-class. Then check the Official Journal to see if the applicable standard is now on the list: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/rtte_en

Note that if the Class 1 sub-class calls up a standard ending “-2” for example, try searching for the standard number without the dash number.

If you need any support with CE Marking under the new Radio Equipment Directive, then please get in contact to discuss how we can help you.

BREXIT & CE Marking Update (March 17)

UPDATE: On 29th March 2017, the UK government delivered a letter to Donald Tusk, President of the European Council announcing its intention to leave the European Union and in doing so formally started the ‘Article 50’ process. The process will now involve a two-year period of negotiation to agree the terms of the UK exit. Fundamental to this is the creation of a ‘Great Repeal Act’ which will transfer the body of EU legislation into UK law.

Within the letter, Theresa May outlined a number of principles which will form the basis of the UK’s negotiations with the EU. Two statements within the letter which may have particular relevance to CE marking are as follows:

“…the Government will bring forward legislation that will repeal the Act of Parliament – the European Communities Act 1972 – that gives effect to EU law in our country. This legislation will, wherever practical and appropriate, in effect convert the body of existing European Union law (the “acquis”) into UK law. This means there will be certainty for UK citizens and for anybody from the European Union who does business in the United Kingdom.”

“We also understand that there will be consequences for the UK of leaving the EU: we know that we will lose influence over the rules that affect the European economy. We also know that UK companies will, as they trade within the EU, have to align with rules agreed by institutions of which we are no longer a part – just as UK companies do in other overseas markets.”

Although not definitive, this does appear to indicate a strong willing to retain existing product compliance legislation post-Brexit.

In terms of the UK’s position with regards to European Standards, BSI have offered the following advice, although it should be noted that this advice was issued prior to the triggering of Article 50 (which can be viewed here on the BSI Group website).

We will continue to follow the Brexit process and consider its effects on CE marking for UK manufacturers. If you wish to discuss any topics related to CE marking, then please get in contact.

Free CE Marking Seminars at Southern Manu Show

The CE Marking Association is once again attending the Southern Manufacturing & Electronics Show (at FIVE in Farnborough) providing CE marking seminars. This year, Peter Evans (Quality Assurance & Engineering Manager at the CE Marking Association) will give an overview of the CE marking process, discuss the implications of BREXIT and look forward to any changes in product and machine safety legislation. At the end of the presentation, there will be an opportunity to ask Peter and his team any questions on CE Marking.

The show runs from the 21st to 23rd March 2017 and our seminar times are:

 
  • Tuesday 21st March @ 10:10am (Seminar Theatre 1) – CE Marking 2017 & Beyond
  • Wednesday 22nd March @ 12:30pm (Seminar Theatre 1) – CE Marking 2017 & Beyond
  • Thursday 23rd March @ 11:45am (Seminar Theatre 2) – CE Marking 2017 & Beyond

 

The show and our seminars are free to attend and there is free parking on-site. It is not too late to register your attendance; visit the industrysouth.co.uk website or register on the day.

A copy of our presentation is available to download (PDF 2.59MB) here.

We hope to see you at the show.

If you would like to follow up any CE Marking questions, then please feel free to get in contact.

Product Compliance after Brexit and The UKCA Mark

eu_flagWith the outcome of Brexit still a matter of some uncertainty, we look at the implications of Brexit on UK Manufacturers placing products on the market in both the UK and the EU.

The UK Government has issued guidance to UK Manufacturers regarding the placing of products on the UK market as well as placing products on the EU market if the UK leaves the EU without a deal. The Government has issued similar advice for Medical Devices and for Construction Products.

With regards to the UK Market, the majority of CE Marking legislation is written into UK law and the legislation that is not, will be transposed into UK law as the UK leaves the EU. Therefore the CE Mark will still represent the legal base mark for products to be placed on the UK market.

The UK Government has made provision for a ‘UKCA’ mark. This is intended to be complimentary to the CE Mark and not replace it, and can be used where the Manufacturer is unable to apply a CE Mark; for instance, this may be if the Manufacturer has made use of a UK Approved Body (The UK equivalent of the EU Notified Body) and only wishes to place their products on the UK Market.

Manufacturers who place products on the market within the EU will not see any change in the legislation that applies to their products – the EU have not indicated that they intend to change any product legislation as a result of Brexit. There are, however some implications of UK Manufacturers being located outside the EU which should be considered:

  • Manufacturers who use a UK Notified Body should contact that body ASAP to understand their ‘Post Brexit’ plans or if, indeed the UKCA mark is more appropriate
  • Manufacturers who distribute through an EU supply chain should understand that the economic operator status of that supply chain will change which may require changes to packaging.
  • Manufacturers of Machinery are also reminded that if they intend to place products on the EU market following a ‘No Deal Brexit’, they should nominate the person who is responsible for compiling the Technical File who must be located within the EU.

A copy of the Statutory Instrument amending UK product compliance legislation in the event of a ‘No Deal’ Brexit can be found here

The advice given above is only applicable if the UK leaves the EU without a deal. The provisions of any Withdrawl Agreement or Future relationship would be bound by those agreements.

 

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The CE Marking Association will continue to keep an eye on future developments and will continue to support our clients with the UK and European product conformity requirements. If you have any questions about CE marking, then please feel free to get in contact.

Original article 4th April 2019

Northern Manufacturing Show Presentation 2016

The CE Marking Association was once again in attendance at the Northern Manufacturing Show at Event City in Manchester. We would like to say thank you for everyone who visited our stand and attended one of our CE Marking Seminars.

A copy of our presentation is available to download (PDF 2.24MB) here.

If you would like to follow up any CE Marking questions, then please feel free to get in contact.

We hope to attend to the next Manufacturing & Electronics Show at Farnborough on the 21st to 23rd March 2017, so hopefully we will see you there. More details about the Southern Show are available here: http://www.industrysouth.co.uk

 

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