Want to sell your medical device in the European Union? Europe accounts for 30% of the world’s medical device market. To get a slice of that pie takes a CE mark first.
The CE mark, also called a CE marking, is a safety designation that is required for many different types of products that are sold in Europe, such as medical devices. The CE mark serves as proof that a medical device has been manufactured to comply with European Union legislation, is in accordance with the EU’s health and safety requirements, and is allowed to be sold in Europe.
Medical devices may be manufactured anywhere in the world, but the CE mark is expected for them to be sold in Europe’s single market. This includes the 28 countries currently in the European Union; plus Iceland, Liechtenstein and Norway, which are members of the European Economic Area (EEA); and Switzerland, which has adopted CE mark rules on a national level.
Each country has its own language requirements for the CE mark. For example, Greece mandates that documentation is available in Greek while Belgium mandates the same in Dutch, French and German. For that reason, translation is an essential element in the process of getting a CE mark and thus selling your medical devices in Europe. Depending on your distribution and marketing plans, this could mean 22 languages.
If you are unsure where to get started, the European Union outlines six steps to achieve a CE mark for your medical device:
First, locate the directives and standards that apply to your medical device. For example, implantable medical devices have different regulations than other types of medical devices.
Second, check any requirements that are specific to your medical device and the countries you plan to sell it in. Plan on how you can meet those requirements if you do not already.
Third, determine if you are required to undergo an independent conformity assessment.
Fourth, evaluate the medical device and its conformity.
Fifth, prepare and keep the necessary technical documentation.
Sixth, fill out the EU Declaration of Conformity and affix the CE mark to your medical device.
We know it is easier said than done, but with good translation on your side, selling medical devices in Europe goes a lot more smoothly.