Once a device is CE Marked, there may be additional registration/notification requirements to consider for individual countries.
Until EUDAMED 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 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 European Single Market, the United Kingdom (UK) and 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
Which Medical Devices & IVDs Require Registration?
Directives versus Regulations
The information in our tool applies to all devices CE marked under both the Directives (MDD, IVDD and AIMDD) and the Regulations (MDR and IVDR).
Until EUDAMED is mandatory, all medical devices (Regulation and Directive legacy devices) are subject to the registration requirements under the Directives.
Class I devices and IVDs
Per the MDD, all Class I devices must be registered by the manufacturer (or its authorized representative) in the member state where they are located. Per the IVDD, all IVDs must be registered by the manufacturer (or its authorized representative) in the member state where they are located.
Class IIa, IIb, III/AIMD Devices
Per the MDD/AIMDD, each Competent Authority (e.g., AEMPS in Spain) may decide on a case-by-case basis if they wish to be informed of Class IIa, IIb and III/AIMD devices being placed onto their market. Each country may also maintain its own medical device registration database, e.g., Italy’s “Repertorio”.
Annex II List A, List B, and self-test IVDs
Per the IVDD, each member state may decide on a case-by-case basis if they wish to receive additional details related to Annex II, List A, List B and/or self-test products (e.g., label and IFU).
What products are included in this registration tool?
Since the registration requirements are clear for Class I and IVD products, our tool covers requirements for Class IIa, IIb, III, active implantable medical devices, Annex II, List A, List B, and self-test IVDs. That said, 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.
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.
Switzerland and the UK
Now that Switzerland and the UK are no longer part of the European Single Market, different registration requirements apply. Our tool includes these requirements.
NOTE: The UK is made up of two territories. Great Britain (England, Scotland, Wales), which is governed by the UK medical device legislation (UK MDR 2002). Northern Ireland, the fourth UK country, is still part of the European Single Market.
EUDAMED & SWISSDAMED
Under the MDR and IVDR, EUDAMED was introduced as a mechanism to reduce the burden of submitting individual country notifications. However, the device registration module of EUDAMED is not yet mandatory. Therefore, 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. For the most current understanding of EUDAMED’s deadlines, please read: EU Commission Proposes EUDAMED Gradual Rollout
Swissmedic is also developing a registration system expected to launch in 2024.
For more information, please read: Switzerland Registration Database (Swissdamed)
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.