The European Union has invented a system where the responsibility to know about every possible standard and directive falls on the manufacturer, more specifically on the company that puts the product on the market.
There exists no government or EU funded authorities which will tell you or help you with knowing what directives or standards your product needs to conform to. The authorities in every country are only there to supervise the market: to find out who doesn’t follow the directives and punish them accordingly. Most often this is done afterthe occurrence of a serious accident, caused by products not conforming to the relevant standards.
So it is up to the company who puts the product on the market to figure out which directives that apply to their product. Most notable directives for electronics are:
- The EMC directive. Applies universally to all electronics, except if the product contains radio. If so then use:
- The radio directive. Currently known as R&TTE – Radio and Telecommunications Terminal Equipment, soon to be known as RED, Radio Electronics Directive. Contains special EMC requirements and also in turn enforces compliance to:
- The low voltage directive. Applies to equipment using voltages from 50-1000VAC or 75-1500VDC (and also to radio equipment).
- The RoHS directive (restriction of the use of certain hazardous substances). Environment concerns.
The above are the major ones for electronics, but you may also need to confirm to other directives if the product is intended for machinery, med-tech, automotive, avionics, high voltage, explosive environments etc etc.
Also, there are non-compatible directives in other countries, most notably the US FCC, that require their own approvals for EMC, radio etc. If you are approved for Europe and US both, you can sell to most other countries too. Countries in South America and Oceania tend to accept either or both of the US and EU approvals (some times with reservations or exceptions). Asia is more complicated as they have national requirements pretty much in every single country. Exporting electronics world-wide is quite a bureaucratic nightmare.
To get back to the EU directives, every such directive comes with a vast list of harmonized, normative technical standards (hundreds or even thousands of standards) that may or may not apply to the specific product. Again, you will get no help from anyone to determine which standards that apply.
If you ask a test house (formally called notified body, they are appointed by the EU), they will happily suggest as many standards as possible, as that means more income for them. It is notable that not even the test houses actually know this, as it is no exact science. They are just better at making a qualified guess than the average person. They also see no moral concerns when it comes to work as consultant for you at first, and then as a “neutral” third party for tests later. Who needs morals when you get twice the pay! Hint: pay them money as consultants first and then the expensive test later on usually passes.
Once you have figured out/guessed which standards that apply, you will most likely have to pay big money for them. Most ISO/IEC standards are quite expensive, particularly if you want them translated to your native language. A few rare cases exist where standards are available free of charge, for example all the normative radio standards from ETSI.
In most cases, there is actually no requirement that you test if your products fulfil the standards. Simply writing a EC declaration of conformity and putting the CE mark on your product is sufficient for the frightening majority of products. There exist a few, very safety-critical products that actually must go through a conformance test by a 3rd party notified body before they are allowed to be put on market.
But in the general case, anyone can put any kind of crap on the market as long as they have a declaration of conformity. And then afterwards, when their non-conforming products have already killed people, the producer may end up in court and their products may get withdrawn from the market.
So for the lone engineer of the new fancy electronics device. If you want to sell your product legally in the European Union:
- Employ one technical bureaucrat who can determine exactly what directives and standards that apply and what you have to do to fulfil them. This is pretty much a full-time job for one person.
- Spend a lot of money on purchasing technical standards and have your employed bureaucrat study them. Or study them yourself, instead of working with actual electronics.
- If you are serious, literally spend a fortune on tests at a test house. We are talking of a sum equivalent to buying one or several brand new cars here.
As you may have noticed between the lines at this point: the system is designed to keep the lone engineer or the small, innovative company out of the market, in favour for the large corporations.
Or alternatively you could skip all of that, just sign a EC declaration of conformity and hope that your products work. But then if you end up in court, you are in some serious trouble. Courts are far more lenient if you can prove that you have put substantial effort into ensuring that your product is fine (by spending a fortune, as described above).