Europe Registration Requirements
While CE marking is the main requirement for medical device and IVD manufacturers to fulfill, there are additional registration/notification requirements to consider for individual countries.
Until EUDAMED (the EU medical device database) is fully functional, the requirements under the old Directives (MDD/AIMDD/IVDD) continue to apply. Brexit and the withdrawal of Switzerland from the European Single Market for medical devices further complicate the registration process.
Our tool helps you keep track of the medical device registration process across 33 countries.
Registration Requirements Tool Features:
- Confirms if a local registration is needed in the EU-27, Iceland, Liechtenstein, Norway, Turkey, the United Kingdom (England, Scotland, Wales, and Northern Ireland), or Switzerland
- Outlines the submission process, including who can submit, how to submit, what to include in the application, and when you can begin marketing the device
- Provides fee amount for the registration, if required
- Includes additional notes, where available, to better understand the requirements and submission process
- Provides helpful links and citations to each Competent Authority (CA) website and any applicable registration forms and/or databases
Casus reviews this data annually. The most recent review date is posted below the search selection options.
The registration requirements provided below are for reference only. Casus Consulting does not take responsibility for the accuracy of this information. Casus Consulting has taken due care in preparing the registration requirements tool, but we do not guarantee, nor do we assume legal liability or responsibility for, the accuracy or completeness of the information contained in these materials.
The registration requirements are publicly available on each Competent Authority website. Links are provided in the tool and individuals should verify the information as published by the Competent Authority before taking any action. Further, if there is a question on a specific requirement, Casus suggests reaching out to the Competent Authority directly to confirm.
Devices Covered within this Tool
- Directives versus Regulations: The information applies to all devices CE marked under both the Directives (MDD, IVDD and AIMDD) and the Regulations (MDR and IVDR).
- Classifications Included: This tool is primarily intended for higher risk-class devices.
- Per the MDD, all Class I devices must be registered by the authorized representative in the member state where they are located. Per the IVDD, all IVDs must be registered by the authorized representative in the member state where they are located.
- Per the Directives, each member state may decide on a case-by-case basis if they wish to be informed of higher-risk devices being placed onto their market. Therefore, this tool covers Class IIa, IIb, III and active implantable medical devices and Annex II, List A, List B and self-test IVDs. However, there are some exceptions, which are noted in the tool below.
- Foreign versus Local Entity Requirements: The requirements detailed below apply to foreign manufacturers placing devices in each market.
- Most (if not all) markets have additional or different registration requirements for local Authorized Representatives and Manufacturers. Specific requirements for local economic operators are not included and may include both additional entity and device registration requirements.
- Custom-Made Devices: Casus’ tool includes requirements for CE Marked products. It does not include requirements for custom-made devices, which may have their own registration process in each market. Manufacturers should review the Competent Authority websites linked below to confirm information related to custom-made devices.
EUDAMED & SWISSDAMED
Under the MDR and IVDR, EUDAMED was introduced as a mechanism to reduce the burden of submitting individual country notifications. However, as the device module of EUDAMED is not yet mandatory, the registration requirements established under the Directives apply unless otherwise stated by a specific Competent Authority.
Many of the below local registration requirements will be removed once the device registration module of EUDAMED becomes mandatory, currently expected in Q2 2026.
For more information, please read: New EUDAMED ‘Go Live’ Date is Q2 2024
Swissmedic is also developing a registration system expected to launch in 2023.
For more information, please read: Switzerland Registration Database (Swissdamed)
Last Reviewed: December 2022