EU country-specific medical device registration requirements

By
Wendy Levine
-
April 14, 2023
EU country-specific medical device registration requirements

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.

Notification submission by:
Country Additional registration requirements Manufacturer, AR, or Distributor Importer or Distributor Competent Authority
Austria No Austrian Federal Office for Safety in Healthcare (BASG)
Belgium Yes X Federal Agency for Medicines and Health Products (FAMHP)
Bulgaria No Bulgarian Drug Agency (BDA)
Croatia Yes X Agency for Medicinal Products and Medical Devices (HALMED)
Cyprus Yes X Cyprus Medical Devices Authority
Czechia Yes X State Institute for Drug Control (SUKL)
Denmark No Danish Medicines Agency
Estonia Yes X Republic of Estonia Health Board
Finland No + Finnish Medicines Agency (Fimea)
France Yes X The National Agency for the Safety of Medicines and Health Products
Germany No ++ Germany Federal Institute for Drugs and Medical Devices (BFARM)
Greece Yes X National Organization for Medicines (EOF)
Hungary No National Institute of Pharmacy and Nutrition (OGYEI)
Iceland * No Icelandic Medicines Agency (IMA)
Ireland No Health Products Regulatory Authority (HPRA)
Italy Yes X Ministry of Health
Latvia Yes X State Agency of Medicines of Latvia (ZVA)
Liechtenstein * No Office of Public Health (AG)
Lithuania No The State Health Care Accreditation Agency (VASPVT)
Luxembourg No Ministry of Health
Malta No Malta Medicines Authority
Netherlands No Dutch Health and Youth Care Inspectorate (IGJ)
Norway * No The Norwegian Medicines Agency
Poland Yes X Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal Yes X Infarmed - National Authority of Medicines and Health Products
Romania No National Agency for Medicines and Medical Devices of Romania (ANMDMR)
Slovakia Yes X State Institute for Drug Control, Medical Devices Section (SUKL)
Slovenia No Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)
Spain Yes X Agency for Medicines and Health Products (AEMPS)
Sweden No Swedish Medical Products Agency, Department of Medical Devices
Switzerland * No Swissmedic
Turkey * Yes X Turkish Medicines and Medical Devices Agency, Ministry of Health (TITCK)
United Kingdom * Yes X Medicines and Healthcare products Regulatory Agency (MHRA)

* 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.

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