The need for new Directives
Some years ago, the European Commission (EC) published the New Legislative Framework (NLF), a separate piece of legislation intended to act upon all CE Marking directives. The 2014 Directives represent the first tranche to incorporate these new provisions.
The EC periodically reviews its legislation to check, amongst other things, that it is effective. One indication is feedback from market surveillance campaigns; this measures how effective individual Directives are at delivering compliant products onto the market.
Market surveillance campaigns consistently show that more needs to be done. The most recent market surveillance campaign for the EMC Directive, for example, sampled 55 solar panel inverters, finding that just 9% met the Directive’s technical and administrative requirements. Delving into the data reveals the samples were only tested for emissions, so the 9% compliance rate assumes that all samples would have met the requirements of all the immunity tests – an unlikely scenario. It also assumes that the two-thirds of samples that did not have their Technical Documentation assessed would have all met the requirements – again, unlikely.
The real compliance level will be lower, but how much lower? No-one knows, as the data isn’t available. What is certain is that this particular market sector is close to being entirely non-compliant.
This is not an isolated example; market surveillance from other CE Marking Directives shows an unacceptably large number of non-compliant products reaching the market – at least in the sectors chosen.
For manufacturers who take their compliance responsibilities seriously, there is an associated cost; whether this is from third-party testing or providing the resources necessary to generate the required documents. Other manufacturers don’t incur these costs and the EC is cognisant of the fact that producing compliant products could be seen as a competitive disadvantage.
The new Directives contain some important changes introduced by the NLF. While the manufacturer remains responsible for product compliance, everyone in the supply chain – from importer to distributor – has responsibilities, all designed to make sure the manufacturer has met the necessary regulatory obligations and that only compliant products reach the end user. The message is clear; the whole supply chain is now effectively policing the correct application of the new Directives.
Placing on the market
CE Marking Directives make reference to placing on the market, defined as ‘the initial action of making a product available for the first time on the Community market, with a view to distribution or use in the Community’.
This wording is often only partially understood; ask a typical manufacturer what this means in practice and the common interpretation is that placing on the market is the equivalent of launching a new product; it is something that happens once and that is the end of the matter.
However, the Directives’ definition is that each product is placed on the market individually and therefore should be compliant; hence the need to ensure on-going compliance beyond that initial product launch.
Non-compliant products on the market fall into one of two categories – those that were never compliant in the first place and those that were compliant when they were initially placed on the market as a new product, but have subsequently ceased to be compliant.
Remaining compliant
A product’s on-going compliance is affected by several factors and only one of these is within the manufacturer’s control.
Firstly, compliance with harmonised European standards is the basis on which a Declaration of Conformity is made for CE Marking Directives. These provide a clear set of requirements to be met in order to satisfy a Directive’s technical requirements. The issue is that all standards change over time; amendments are issued periodically, followed by complete revisions every few years.
New and revised standards are accompanied by a transition period, typically two or three years. During this time, the manufacturer can choose whether to continue to use the old version or to move to the new one. But, beyond the end of the transition period, only the new version applies. Therefore, the manufacturer needs to be assured the product is actually compliant with the new requirements and reflects this in the Technical Documentation and Declaration of Conformity (DoC).
Secondly, whilst standards change relatively frequently, Directives do not normally change from one year to the next. But 2016 is an exception and the nine updated Directives are all new pieces of legislation with new numbers which need to be reflected on the DoC. For example, the new EMC Directive came into force on 20 April 2016 with no transition period; from this date, DoCs for current products should refer to 2014/30/EU. Any ‘current’ DoCs still referring to 2004/108/EC are invalid as this Directive has been superseded.
“The message is clear; the whole supply chain is now effectively policing the correct application of the new Directives.” Nick Wainwright
Lastly, the product itself – something over which the manufacturer does have control – is likely to be subjected to a number of changes, including: necessary design changes; obsolete components; cheaper components; and additional functionality, all of which will result in a product that is different in some way to the one which was initially placed on the market. Just like for changes to standards, the manufacturer needs to be assured that the updated product is actually compliant and reflects this in the Technical Documentation and DoC.
Ensuring these three aspects are reviewed regularly should result in on-going compliance.
Protecting brand reputation
What can take many years to build can be tainted very quickly through adverse publicity. Currently, mention of the Samsung Galaxy Note 7 is more likely to conjure up images of melted phones, rather than a device at the forefront of mobile technology. Even for a company of Samsung’s size and resources, this will take some time to shake off.
Meeting the requirements of the relevant CE Marking Directives is also a form of brand protection. The Directives are in place not only to allow the free movement of goods within the EU, but also to ensure that products are safe and reliable; an inherent consumer expectation. Products that are not compliant, or those where the manufacturer cannot adequately demonstrate that they are, may be hindered within the supply chain through the additional responsibilities on importers, authorised representatives and distributors.
Moreover, the new Directives seek to ensure that market surveillance is more robust and that the identification of products, particularly where they have been rebranded, can be more easily established so that their path through the supply chain can be established. Non-compliant products detected in one country can lead to the removal from the market in all Member States.
With the stated aim of the new Directives focussed firmly on ensuring that only compliant products reach the market, manufacturers need to be aware of their responsibilities, now more than ever – not only to ensure that a product is compliant at launch but also that compliance is on going.
Author profile:
Nick Wainwright is chief executive of York EMC Services.
