There are 27 member states that belong to the European Union (EU), along with additional countries that participate in the European Economic Area (EEA) and the EU’s single market. One of the benefits of belonging to the EU is the unification of regulations for medical devices and in-vitro diagnostics. As you know, registering medtech devices (ultimately known as applying the CE Mark) is a complex process. Applying the CE Mark allows your devices to easily be imported and sold throughout Europe.
Some of the member states and those participating in the single market require additional registration steps beyond those required by the EU for class IIa, class IIb, and class III medical devices. In general, a medical device manufacturer is required to submit a registration form and/or enter information in the online database before placing the product on the market. Typically, this notification includes the upload of a localized label, instructions for use, Declaration of Conformity, and the CE certificate.
The additional registration requirements apply to manufacturers outside of the EU who wish to market devices in an EU member country. Most markets will also have additional or different registration requirements for local Authorized Representatives and Manufacturers. Once EUDAMED is fully implemented, the assumption is that most of these country-specific registration requirements will be removed.
The table below lists all 27 EU member states, along with additional countries that participate in the EU single market. This table is for reference only – Regulatory professionals are urged to consult country Competent Authority websites for country-specific requirements.
* Countries not in the EU
+ Devices supported by Finnish distributors to hospitals and retailers require notification.
++ Registration may be required if an importer, authorized representative, or manufacturer located in Germany is placing the product on the market for the first time.
Note: Specific requirements for local economic operators are not included here and may include both additional entity and device registration requirements.