FAQs
MDR / EUDAMED Device Registration
What is EUDAMED?
The European Database on Medical Devices (Eudamed) is a database that serves to centrally store medical device information to inform the public about devices placed in the EU market, certificates that were issued by notified bodies, monitor the safety and performance of medical devices and facilitate efficient post-market surveillance.
EUDAMED is a great tool to improve quality, transparency and regulatory operations for medical devices manufacturers, notified bodies, competent authorities and the public as a whole.
What are the different modules of the EUDAMED database?
- Actor Registration
- Device Registration
- Notified Bodies & Certificates
- Clinical Investigations & Performance Studies
- Vigilance
- Market surveillance
What are the goals of the EUDAMED database?
The most important ones are the following:
- Enable the public to be informed about the medical devices currently on the market, including their manufactures and certificates.
- Facilitate the unique identification of devices for post-market surveillance and traceability.
- Ensure the public is informed about clinical investigations and performance studies.
- Provide competent authorities of member states with reliable data for market surveillance.
What are the general key dates?
- 26th May 2021: Date of application of the EU MDR. After four years of transition followed by a global pandemic in 2020, we reached a regulatory milestone on May 26, 2021 for Medical Device manufacturers in the European Union – with Medical Device Regulation 2017/745 finally taking effect.
- End of September 2021 – Device Registration Module expected to be available for voluntary use.
- 26th May 2022: Expected date for a fully functional EUDAMED to go live.
- 26th May 2024: Certificates issued under MDD/AIMDD become void if they have not expired already. This is the last date for placing medical devices on the market unless they meet MDR requirements.
- 26th May 2025: the last date for end-users (hospitals, for instance) to put products under the Directives (MDD/AIMDD) into service.
What do manufacturers need to consider for registering devices in EUDAMED?
Manufacturers need to determine the ‘intended purpose’ of the device they plan to place in the EU market. Article 51 requires medical devices to be classified into one of four risk classes (Class I, Class IIa, Class Ilb and Class III). The classification is important as it has subsequent implications in the conformity assessment that needs to be done by the applicable Notified Body. You also need to determine how the product is distributed within EU. If you are not a legal manufacturer based in EU, you need to designate an ‘Authorized Representative’ within the EU that can act on your behalf. You may also have an Importer that needs to register with the authorities and have their own responsibilities for MDR compliance.
Manufacturers, Authorized Representatives and Importers need to register in EUDAMED via the Actor Registration Module and get their Single Registration Number (SRN) after a review by the national competent authority (CA).
Manufacturers can then proceed to register their devices in the Device Registration Module in EUDAMED. If a device falls under a risk classification that requires a Notified Body to be involved in the conformity assessment, the device is put in a ‘Submitted’ status until the designated Notified Body uploads the relevant certificates in the Certificates module. Once the Notified Body uploads the certificates, the device registration status is changed to ‘Registered’.
What’s the European Medical Device Nomenclature (EMDN)?
The European Medical Device Nomenclature (EMDN) aims to facilitate the purposes of MDR and IVDR requirements in the identification and documentation of devices including for purposes of device registration in EUDAMED, certification by Notified Bodies, vigilance and post-market surveillance. It is associated at the Unique Device Identifier – Device Identifier (UDI-DI) level. EMDN permits global operators to recognize medical devices and interchange information concerning the performance and safety of the device. It is the outcome of the collaborative work of medical device professionals from all over the world and directed by the European Commission.
EMDN is based on the Italian Ministry’s ‘Classificazione Nazionale Dispositivi medici (CND) standard and is accessible to all stakeholders free of charge. A first version of the EMDN was released on 4 May 2021.
What do manufacturers need to consider for registering devices in EUDAMED?
Manufacturers need to determine the ‘intended purpose’ of the device they plan to place in the EU market. Article 51 requires medical devices to be classified into one of four risk classes (Class I, Class IIa, Class Ilb and Class III). The classification is important as it has subsequent implications in the conformity assessment that needs to be done by the applicable Notified Body. You also need to determine how the product is distributed within EU. If you are not a legal manufacturer based in EU, you need to designate an ‘Authorized Representative’ within the EU that can act on your behalf. You may also have an Importer that needs to register with the authorities and have their own responsibilities for MDR compliance.
Manufacturers, Authorized Representatives and Importers need to register in EUDAMED via the Actor Registration Module and get their Single Registration Number (SRN) after a review by the national competent authority (CA).
Manufacturers can then proceed to register their devices in the Device Registration Module in EUDAMED. If a device falls under a risk classification that requires a Notified Body to be involved in the conformity assessment, the device is put in a ‘Submitted’ status until the designated Notified Body uploads the relevant certificates in the Certificates module. Once the Notified Body uploads the certificates, the device registration status is changed to ‘Registered’.
Did You Know?
26 May 2021 marks the start of transition arrangements from the former Medical Device Directive (MDD) to new Medical Device Regulation (MDR) until 26 May 2024.
What’s the European Medical Device Nomenclature (EMDN)?
The European Medical Device Nomenclature (EMDN) aims to facilitate the purposes of MDR and IVDR requirements in the identification and documentation of devices including for purposes of device registration in EUDAMED, certification by Notified Bodies, vigilance and post-market surveillance. It is associated at the Unique Device Identifier – Device Identifier (UDI-DI) level. EMDN permits global operators to recognize medical devices and interchange information concerning the performance and safety of the device. It is the outcome of the collaborative work of medical device professionals from all over the world and directed by the European Commission.
EMDN is based on the Italian Ministry’s ‘Classificazione Nazionale Dispositivi medici (CND) standard and is accessible to all stakeholders free of charge. A first version of the EMDN was released on 4 May 2021.
What is the Basic UDI-DI?
The “Basic UDI” is introduced by EU’s Medical Device Regulations to represent a device model. A device model is a family of products that share similar characteristics (i.e. products with similar attributes). Those common attributes are defined within the EUDAMED system to construct a Basic UDI record, and this device record structure includes a unique identifier, called the “Basic UDI – DI” (also known as BUDI for short) to identify the device model.
For Medical Device manufacturers that are using GS1 as their Issuing Entity, the structure of a BUDI identifier is represented by the GMN – a Global Model Number which includes the:
- Manufacturer’s GS1 Company Prefix;
- The device model reference or internal number
- Check digits
The GMN can be a maximum of 25 characters including the two mandatory check characters. The check characters are calculated using a Modulo-80 algorithm based on the contents of its preceding characters (just like check-digits of a GTIN used for the UDI-DI), but these check-characters can be alphanumeric.
Many organizations are faced with the challenge of generating and assigning BUDI Identifiers in their PLM, ERP and PIM applications. Innovit has encapsulated the rules to simplify and automate the generation, validation and assignment of Basic UDI-DIs for our customers, based on their specific product identification requirements.
Which documents contain the Basic UDI-DI references?
The Basic UDI-DI is intended to identify a product model and connect associated regulatory documents much more easily. Some of these documents include:
- EU Declaration of Conformity
- Technical Documentation Assessment Certificates
- Type-Examination Certificates
- Product Verification Certificates
- SS(C)P – Summary of Safety and (Clinical) Performance
The Basic UDI-DI does not appear in any packaging/labelling of the device.
What remaining work needs to be done specifically on EUDAMED?
The EU MDR Date of Application on May 26th, 2021 marks an important milestone to continue regulatory momentum and to focus on upcoming dates specifically for EUDAMED. The next version of the Device Registration Playground is due to be available at the end of July 2021 before it goes into production at the end of September. The scope for the remaining modules (i.e. Clinical Investigation, Vigilance and Market Surveillance) still needs to be finalized while they’re still targeted to be available on May 26th, 2022.
How can Innovit help?
Get started today for free with Innovit’s EUDAMED.cloud – your free one-stop Knowledge Center for everything you need to know about complying with EUDAMED!
We have all the tools you need to prepare for EUDAMED compliance.
- Gain full visibility into EUDAMED data requirements
- Gather and validate your BUDI and UDI data
- Data quality review & approval processes systemized
- Train and test your staff in Innovit’s EUDAMED playground environment
- Go-live and share your data to EUDAMED from September 2021.
Get Started for free with Innovit’s EUDAMED.cloud solution!