UK MHRA Opens New Public Consultation: International Reliance, IVD Regulatory Process, and more
14 November 2024
November “In All Other News”: New MDCG Guidance, Updates from Team NB, and more
3 December 2024Overview
The Q&A is available: HERE
The guidance covers questions such as: when will EUDAMED become mandatory, clarification on which companies and devices are (or are not) exempt from registration, and more. Below we outline some of the items addressed; please refer to the guidance for the full list of questions & answers.
Actor Module
Which organizations need to register?
The following types of organizations must register themselves in the EUDAMED:
- Manufacturers
- Authorized representatives
- Importers
- System/Procedure Pack Producers
- Sponsors of clinical investigations/performance studies, in order to submit applications in the Clinical Investigation/Performance Study module or report serious adverse events.
Which organizations are exempt from registration?
- Distributors
- However, they may have registration obligations on the national level
- Manufacturers, importers, and System/Procedure Pack Producers who will not place devices or systems/procedure packs on the European market after the use of EUDAMED becomes mandatory
- Unless they need to take a post-market surveillance or vigilance related action in the Post-market Surveillance and Vigilance module
Read here for the difference between an Importer and Distributor: Importer vs Distributor
Note on Custom-Made Devices (CMDs)
The above information does not include Custom-Made Devices. Manufacturers of CMDs must meet the following requirements:
- Manufacturers who exclusively sell Class III implantable CMDs must register themselves, so their Notified Body can register the manufacturer’s QMS Certificate in the Notified Body/Certificates module
- Manufacturers of all other custom-made devices are exempt from registration, unless:
- They will market non-CMDs, in addition to CMDs
- They need to use any of the other EUDAMED modules, e.g., report a serious incident in the Post-market Surveillance and Vigilance module
UDI/Devices Module
Which Devices Require Registration?
The following types of products must be registered:
- Regulation medical devices & IVDs
- Legacy
medical devices & IVDs
- See section below for possible exemptions from this requirement
- Systems and procedure packs
Read here for more information on Systems/Procedure Packs: EU/Swiss/UK Guide to Systems/Procedure Packs and Kits
Which devices are exempt from registration?
- Devices where individual (sales) unit are no longer placed on the market when the UDI/Device module becomes mandatory
- Unless the manufacturer needs to take a post-market surveillance or vigilance related action in the Post-market Surveillance and Vigilance module
- ‘Old’
devices
- If the device is the subject of a serious incident report (MIR) or field safety corrective action (FSCA), the manufacturer will need to provide a limited device data set to submit the relevant report in the Post-market Surveillance and Vigilance module
- Custom-Made Device
- If the device is the subject of a serious incident report (MIR) or field safety corrective action (FSCA), the manufacturer will need to provide a limited device data set to submit the relevant report in the Post-market Surveillance and Vigilance module
- A legacy device that is ‘the same device’, as is already registered as a Regulation device
- Unless the manufacturer needs to take a post-market surveillance or vigilance related action in the Post-market Surveillance and Vigilance module
- ‘The same device’ means that the Regulation device and the legacy device have the same identification, such as UDI-DI, and/or catalogue/reference number, and/or trade name which follows from shared characteristics.
Timing
Actor Module
The Actor module will become mandatory six months after its full functionality is published in the Official Journal of the European Union (OJEU). For example, if the notice is published in the OJEU January 1, 2025, then Actor registration will become mandatory by July 1, 2025.
Note that you can voluntarily register early. You do not have to wait for publication in the OJEU to register your organization in the Actor module.
Read more about the process here: How to register your company in the EUDAMED Actor module
UDI/Devices Module
For devices being newly placed onto the market after the UDI/Devices module becomes mandatory, the device must be registered before the first individual unit is placed on the European market.
For devices already being placed on the market before the UDI/Devices module becomes mandatory, they have 12 months to register, after its full functionality is published in the Official Journal of the European Union (OJEU).
For example, if the notice is published in the OJEU January 1, 2025, then UDI/Device registration will become mandatory by January 1, 2026.
Note that you can voluntarily register early. You do not have to wait for publication in the OJEU to register your products in the UDI/Devices module.
Read more about the process here: How to register medical devices and IVDs in EUDAMED
