CE certification, my introduction.
My first job started on April 14th 2001 at a TIC company in the Netherlands. Professional in selling CE certification the CE mark I would say that time. They were an experienced telecom testing laboratory. Leased line technology (PSTN) was there focus. Telecom equipment connected to the network should comply to each country law. Until April 8th. 2000 it was mandatory to have the telecom equipment tested by a governmental designated test laboratory and certification body. This monopoly position changed from one to the other day. The New Approach was devastating for the established order in the TIC industry.
The New Approach.
It was just 1 year the Directive 1999/5/EC came in force when I started my job. The (R&TTE) Radio & Telecom Terminal Equipment Directive came into force on the 8th. of April 2000. Under the so called “New Approach” legislation. Of course free movement of goods was a fundamental objective of the single European market. The mechanism in place to achieve this aim where based on prevention of new barriers to trade. In addition mutual recognition and technical harmonization ‘New Approach’ directives came in effect. This process allowed products legally manufacturer of marketed in one country to move freely throughout all member states of the EU. The success of the European standardization system in removing technical barriers to trade have played a vital role in ensuring fee movement of goods between the member states. Moreover that was the time when the market really opened. When would globally a same regulations harmonization be achieved so that one single approval can result in 1 global approval? This would be less positive for our Approval Service.
Few key principles of the New Approach.
- Separation between EU legislation and European standardization;
- EU legislation is limited to the essential requirements;
- Drawing up corresponding technical specification is entrusted to the standardization bodies;
- Products manufactured in conformity with harmonized standards are presumed to be in conformity to to the essential requirements;
- Standards to show compliance to the essential requirements are not mandatory and remain voluntary ;
- Standards must offer guarantee of quality with regard to the essential requirements.
- Public authorities are still responsible for the protection requirements to there territory;
- Safeguard clauses require the Member States to take all measures to withdraw unsafe product from the market.
The European Commission directives defined the “essential requirements”. Correspondingly these are described as:
- 3.1(a) health and safety
- 3.1(b) adequate level of electromagnetic compatibility
- 3.2 effectively and efficient use of the radio spectrum
The New Legislative Framework
The New Legislative Framework is the modernization of the New Approach for marketing of the products and adopted on July 9th. 2008. Moreover the start of renewing directives and regulations.
On June 13th. 2016 the modernization of the R&TTE directive came in force. The RED 2014/53/EU (Radio Equipment Directive).
CE certification and CE Mark
The CE Mark is the indication that your product meet the ‘Essential Requirements’ of all applicable directives and that the products have been subject to a conformity assessment procedure provides for in the directives. You use the Harmonized standards or other. In addition test reports to these standards are showing you meet the essential requirements are always included in your Technical Construction File.
You must label the end product with the CE mark when meeting the essential requirements. The CE certificate is as a matter of fact an undefined piece of paper when following the European directives and regulations. In the years I have seen a lot of so called “CE certificates” which are nothing more then a declaration issued by some kind of external party. As a matter of fact the directives are not familiar with the term “CE Certificate” however they are familiar with the “EU-Type examination certificate”.
The EU country local notifying authority is appointing the Notified Body who can issue the “EU-Type examination”. The nando website shows the list of appointed Notified bodies. These listed Notified Bodies can issue the “EU-type examination” to there designated scope. Notified bodies only come in place when NOT having used harmonized standards (OR you explicitly request this service) when showing compliance with the essential requirements. Showing compliance to the market and a showing a higher level of Impartiality is for many manufacturers a reason to request this service with the EU Type examination as outcome.
Being sure you have received a true “EU-type examination” check the link above.
A lot of test laboratories these day’s offer so called CE certificates. These documents are not the document you think they are and can not replace the “Declaration of Conformity”.
Declaration of Conformity
Not only the CE mark but also the EC Declaration of conformity (DoC) is compulsory. Responsibility lays at the manufacturer or the authorized representative in the community. A procedure, in which they declare that the product placed on the market complies with all the relevant requirements of the appropriate directive. This form needs to be provided with every product and in users language. Also this document is NOT a CE Certificate! Together with with the Technical construction file this needs to be filed for 10 years from last date of placing on the market.
CE Certification, To be or Not to be!
Summary with regard to CE Certification and CE mark.
- Your product placing on the market needs to comply with the essential requirements as described in the applicable directive or regulation.
- The economic operator placing the product on the EU market has the responsibility for compliance;
- CE mark is compulsory and furthermore not for sale;
- The CE Certificate is not for sale and does not exist following the directives;
- The EC-Type Examination does exist and can be requested at a Notified body when showing compliance other then having used harmonized standards.
- Filing of the Technical Documentation containing the DoC is for 10 years.
- RF module, partial compliance to the essential requirements of the directive, can not lead to a direct compliance to the directive of the final product.
- Start as soon as possible with the compliance approval procedure, best before product design to increase success!
Great Britain and CE mark
Combinations of Directives and Regulations
As the integration of IoT modules into e.g. consumer electronics, Industry, Education and healthcare are increasing it is nowadays common that for product marketing compliance to more than one regulation, the directive is required. An example is IoT in Healthcare. This is certainly not the easiest combination.
As from October 1st. 2020, IoT Consulting Partners has the availability of their exclusive Online shop. Not only IoT related services concerning the European regulations, but also for United States, Canada, Japan, UK, or across the world can be found. COVID-19 does increase the essential need for more transparency in IoT and IoMT related and online services.
To diversify from our competitors and fulfill market requirements we see that offering our services on-line results in more efficiency.
Several cards and methods are accepted. More will come.
In case of further questions.
It is understandable that more questions will pop up when starting your compliance procedure for your new device. Check our services page for further assistance and feel free to contact us by the on-line form or on-line chat. We are sure we can get you immediately back on track.
For IoT Startups we offer a special arrangement on top of the 30% coupon discount, however also request for our Sponsor deals!