We have been looking for a similar article on the Internet for a long time. All we found were highly technical and basically uninformative pages about what a CE or a declaration of conformity is, from which we knew the same as before we read them. So I apologise in advance to newcomers who were looking forward to finding out about other freeze-dried foods. This time the topic of the article will be a little different.
I guess I'll try to describe what the famous CE is to begin with. It is the marking of a product and it says that an EC Declaration of Conformity has been issued for that product. Some may wonder, but it means nothing more and nothing less. Just because you find a CE on something doesn't say anything at all about the quality of the device, how powerful it is or that it is made in the EU. CE simply means "There is an EC Declaration of Conformity for the product".
This brings us to the question "What is the EC Declaration of Conformity?". We've probably all seen one when we've bought a coffee machine or a fridge. In short, an EC Declaration of Conformity is someone's commitment that they have compared a product with European regulations and found it to be in conformity with those regulations. That someone may be the manufacturer, importer or seller.
So if you want to manufacture a lyophilizer, you can make your own EC Declaration of Conformity (indeed, you have to - no one will do it for you). However, if the proper authority (especially the Czech Trade Inspection Authority) finds out that you have not verified compliance with the required EU standards, the penalty will not pass you by, and from what I have been able to find out, it can be hundreds to millions of EURO.
But how do you find out which regulations apply to your product and how do you verify them honestly? Either you have a company full of people and there are those who will do it (e.g. an inspection engineer with the appropriate qualifications will verify compliance with the Low Voltage Equipment Decree 2014/35/EU) or you can turn to a so-called notified person. To make things not so simple, not every Notified Person can verify everything and different companies are differently specialised. In the end, we chose the Engineering test institute, public enterprise (SZU).
SZU also verified for us which standards apply to our freeze dryer. Thanks to them, we can be sure that none of our customers will be harassed by a government official, as can happen with products that the manufacturer verifies himself. An example is the 2006/42/EC - Machinery Standard, which is required if you want to use the lyophilizer for business and not just for home use.
Above all, the user is assured that, for example, the electrical safety has actually been verified by someone who understands this and that the manufacturer has not just written a piece of paper himself.
It is also worth mentioning that there are only a few products that are legally required to be verified by a notified person. These include, for example, toys or medical devices. For the vast majority of products, there is no such obligation, and it is then a question of enforceability, for example with an Asian manufacturer, if damage or injury occurs due to non-compliance with the standards.
Once the contract is signed, you can take the instrument to the institute and happily wait for confirmation that everything is in order and the test reports are being printed. Instead, you get a list of about 20 points of what is wrong and what does not meet the standards. Some things become clear on the spot and some things really need to be fixed/adjusted, from a sticker on one component that is unreadable after a minute of rubbing with alcohol (so the standard says) to a 1250 V overvoltage test where a component is putting out more than 20 mA to the " frame".
You can argue about the occasion when more than five times the voltage in the socket gets into the device (we ourselves have only come across the moment when someone would connect the AMARU directly to the lightning rod during a thunderstorm), but it makes no sense. The rules are fixed, and if you choose the notified person verification route, you can count on them being followed to the letter.
When you have positively dealt with all the comments, you will find out that it was only one test station (e.g. electrical) and a similar process awaits you for the electromagnetic compatibility (EMC) measurements and the 2006/42/EC machinery measurements. The whole verification takes about a month, but of course this does not include the time necessary for transporting the instrument between Prague and Brno or the time you spend modifying the instrument to make it compliant.
It may sound like we want to complain about the nonsensical standards and requirements of the European Union, but the opposite is true. After all, we can sleep well at night knowing that every AMARU is safe, meets even multiple limits and can be sold to all EU member states without further obstruction.