What is EUDAMED and what new requirements should medical device companies take into account?

What is EUDAMED and what new requirements should medical device companies take into account? | QbD Group

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The new medical device regulations and the associated implementation of EUDAMED should give the general public access to relevant information about medical devices and thus provide more transparency.

We can only encourage this, but EUDAMED also comes with new requirements for market participants present throughout the life cycle of medical devices. Learn more about these new requirements below!

What is EUDAMED?

EUDAMED – the European Database on Medical Devices – was launched to exchange information between the European Commission (EC) and national competent authorities. The development and implementation of this IT system is a high priority for the Commission. It has been developed to implement the MDR or Medical Devices Regulation (EU) 2017/745 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

EUDAMED aims to visualize the life cycle of medical devices made in the European Union (EU) and available on the European market. This secure, web-based portal will act as an interpretable registration, collaboration, reporting, and dissemination system accessible to the public.

The overall transparency of information would improve with EUDAMED. It provides national competent authorities, such as healthcare professionals, with quick and easy access to relevant regulatory information. Information coordination between the different EU Member States will also be improved to implement a unified approach to the Medical Device Directives.

EUDAMED’s 6 modules: an overview

The EUDAMED database is built around 6 interconnected modules and a public website. The EUDAMED modules include:

actor registration,
unique device identifier (UDI) and device registration,
notified bodies and certificates,
clinical and performance studies,
vigilance,
and market surveillance.

and will contain some of the following data:

registration of manufacturers,
their authorized representative and the devices in particular,
declaration of conformity,
monitoring and traceability system (declaration or ISO certificate),
labeling and instructions,
justification of the classification,
copy of ISO certificate or proof of QMS,
information from clinical studies,
Etc.

Below, we briefly explain each EUDAMED module.

1. Actor Registration module

The EUDAMED Actor Registration Module was the first module to become available in December 2020 to the following actors:

regulatory bodies (such as EC, competent/designating authorities, notified bodies),
economic operators (such as manufacturers, procedure kit/system manufacturers, importers, and authorized representatives)

and sponsors of clinical/performance studies.

This module allows the registration of the various actors in the field of medical devices. Actors must enter data such as name, address, information about the person in charge of regulatory compliance, website, etc. to obtain an actor identifier/single registration number (Actor ID/SRN). Most of the information about actors will be available to the public.

Looking for an EU or non-EU manufacturer, system/procedure packaging producer, authorized representative or importer?

Click here to visit the EUDAMED Actor Registration Module

2. Unique Device Identifier (UDI) modul

The second module, UDI and Device Identification and Device Registration, is for medical device registration and allows system/procedure package manufacturers and manufacturers to enter and update UDI core data elements of medical devices, and to register legacy devices.

This module became available in October 2021, except for the Clinical Assessment Consultation Procedure (CEDP) and the Review Mechanism. The CEDP procedure and the mechanism for scrutiny of the second module will be released when EUDAMED is fully functional together with the remaining modules. The full functionality of the database is expected to be launched in May 2022.

Do you want to search for UDI-DI and device data including SS(C)P?

Click here to visit the EUDAMED UDI Module

3. Notified Bodies & Certificates module

The third module is intended to enable communication between notified bodies and makes it possible to make the summaries of safety and clinical performance and their assessment reports of notified bodies available to the public.

It contains information about notified bodies, such as information about their appointed experts. Apart from that, there are several processes managed by EUDAMED notified bodies. The main one relates to the issuance of CE marking certificates, a process that also includes the refusal, restriction, suspension or revocation of a certificate.

4. Clinical Investigation module

The Clinical Investigation module is the fourth module of EUDAMED. This module covers the management of data from clinical trials and performance studies for IVDs.

The main actor for this module is the sponsor, who, together with any of the competent authorities involved, can make important notifications and changes to the status of the study.

At the time this blog post was published, this module was not yet operational. Please check this link for the latest status.

5. Vigilance module

Like the Clinical Research module, the Vigilance module has multiple actors working together in a process. Manufacturers may report trends in incidents that are not serious incidents or for which adverse events are expected that show a statistically significant increase in frequency or severity.

These Trend Reports must be uploaded and made available to the appropriate Competent Authorities and Notified Bodies. Vigilance is the most complex module to manage, as the consequences of an error or misunderstanding can be the greatest.

At the time this blog post was published, this module was not yet operational. Please check this link for the latest status.

6. Market Surveillance module

Part of EUDAMED is being established to facilitate coordination and cooperation between Member States. This module allows Member States to upload their summaries of market surveillance results, as well as reports of inspections carried out on economic operators.

This information will be kept almost entirely between the competent authorities and the European Commission. Notified bodies also have access to information about device certifications in which they are involved. The summary reports of the Member State’s market surveillance activities will also be publicly available.

At the time this blog post was published, this module was not yet operational. Please check this link for the latest status.

What EUDAMED data will be publicly available?

EUDAMED is partially open to the public. Among others, the following items will be publicly available from the launch of EUDAMED, or from the moment they are uploaded to the database:

identities of economic operators and sponsors,
restricted datasets of devices,
nomenclature codes for medical devices and their descriptions,
list of notified bodies designated,
issued and refused CE marking certificates,
summaries of safety and clinical performance,
applications and notifications for clinical investigations or performance studies, except for notifications of withdrawn applications,
reported adverse reactions and device defects,
summaries of clinical studies or performance studies before devices or within one year of submission to EUDAMED,
summary reports of the Member States’ market surveillance activities.

Other items may become publicly available at a later stage. Information that was not publicly accessible in EUDAMED at the time of entry will remain confidential.

What should be your next steps?

The full implementation of EUDAMED has been postponed a few times already, at the time this blogpost was published, three modules were available.

The remaining three modules (Clinical Investigations and Performance Studies, Vigilance and Post-Market Surveillance , and Market Surveillance) are expected to be launched when EUDAMED if fully operational in May 2022.

Therefore, please keep a close eye on the EUDAMED website.

In case you still have questions on the correct application of EUDAMED on your specific device or your specific role within the lifecycle of medical devices, don’t hesitate to contact us. Our experts are happy to assist you!