With its 30% share, Europe is a big player in the medical devices market. European regulations controlling manufacturing, marketing and usage of the medical devices, also controls the language requirements for the medical devices that will be sold in the European Union.
Since its first introduction in the 1990’s, one of the important consequences of the regulations was virtually eliminating the costly regulations imposed by the individual Member States. Medical device manufacturers simply were able to apply for the CE Mark for their products and this multinational standardized mark was giving them the “passport” to sell in European Union without any additional testing or approvals.
But regardless of this harmony between the Member States, as expected, each state is forcing manufacturers to translate their documents into their own local languages. Depending on the presence of your product, there are currently 24 languages in the EU that should be used. With current and potential new candidates, this number most likely will only grow.
How New Regulations Will Affect Medical Companies?
The latest 2017 MDR and IVDR will continue to enable a multilingual approach to sell devices across the EU by delegating the decision as to which languages are needed for each territory to the Competent Authorities in each Member State.
As expected, new regulations apply progressive regulatory requirements to medical devices and their accessories depending on the classified risk. But different from the older versions, new regulations define a serious of rules which consider devices’ risk to patients, their function and intended use. This risk matrix determines whether conformity assessment can be carried out internally or whether they need to be assessed by a Notified Body.
By general consensus, the regulations will result in an increase in the number of devices requiring a third-party Notified Body to independently certify compliance before a manufacturer can declare conformity and finally use the CE mark. This is also likely to result in significant changes to technical documents and additional translations where a product has been reclassified.