Regulation (EU) 2017/745 on medical devices (MDR) comprises various articles. Its Article 33 requires European Commission to set up a European database on medical devices “EUDAMED.” This EUDAMED will comprise six different electronic systems that will be designated as “modules.”
These modules can facilitate in various places such as:
- Collation and processing of information under EU MDR regarding the registration of relevant economic operators
- Devices and systems and procedure packs (UDI)
- Notified Bodies and Certificates, and certain aspects of
- Conformity assessment
- Clinical investigations
- Vigilance
- Market surveillance
- Post-market surveillance.
According to a notice published by the Commission on 30th October 2019, EUDAMED requires individual and joint availability and operation of all six modules. This availability of modules will help to launch EUDAMED in May 2022. Therefore, until it is launched and fully functional, some alternate solutions can be used for information submission and exchange.
Alternative Solutions for Submission and/or Exchanging the Information
Registration of Devices-Article 29
Using EUDAMED System for Device Registration
Once the functionality is available in EUDAMED, the system can register devices even before the publication of notice regarding EUDAMED’s full functionality. In this regard, the manufacturers should refer to the Member States’ national provisions that establish the product registration schemes.
Manufacturers should also note that:
- According to Article 27(3), the obligation of UDI assignment (basic UDI and UDI-DI) to a device applies from 26 May 2021
- As per Article 123(3)(f), labeling requirements apply gradually, starting from 26 May 2021.
Registration of Manufacturers, Authorized Representatives, and Importers-Article 31
Using EUDAMED System for Registration of Manufacturers, Authorized Representatives, and Importers
Once the functionality is available in EUDAMED, the system can be used for the registration of
- Manufacturers
- Authorized Representatives
- Importers.
This registration of manufacturers, Authorized Representatives, and importers can be done even before the publication of notice regarding EUDAMED’s full functionality. However, manufacturers, Authorized Representatives, and importers should refer to the national provisions in the Member States in this regard.
Summary and Safety of Clinical Performance-Article 32
Availability of SSCP to the Public
Upon public request
- The Summary and Safety of Clinical Performance (SSCP) shall be made available without any undue delay
- The manufacturer can specify where it has been made publicly available or not.
Once the functionality is made available in the EUDAMED, the system can be used for uploading the SSCP even before the publication of notice regarding EUDAMED’s full functionality.
European Database on Medical Devices-Article 33
Submitting Different Sets of Required Information
From the date the Commission ensures availability of the respective EUDAMED module, submitting different sets of the required information will become possible voluntarily.
Nomination of Experts for Joint Assessment of Applications for Notification-Article 40
CircaBC (Communication and Information Resources Center for Administrations, Businesses, and Citizens)
Through a dedicated secure directory in CircaBC (Communication and Information Resources Center for Administrations, Businesses, and Citizens), the Commission has already made the availability of the list to the Member States.
Designation and Notification Procedure-Article 42
NANDO and Publication of Notifications
NANDO is used for publishing notifications.
Identification Number and List of Notified Bodies-Article 43
NANDO and Availability of Information
NANDO is used to ensure the availability of information.
Monitoring and Re-assessment of Notified Bodies-Article 44
Uploading the Reports to the Secure CircaBC Directory
As referred to under Article 42, the Member States should upload the reports to the secure CircaBC directory. Once uploaded, the Commission shall ensure that the summaries of these reports are available to the public.
Changes to Designation and Notifications-Article 46
Suspension or Withdrawal of Certificates
Management of the information about requests for withdrawing or suspending certificates is done at the national level.
Informing the Competent Authority by Suitable Communication Channels
For each Member State where the manufacturer has his registered place of business, the process of informing the Competent Authority for medical devices should be done by suitable communication channels such as
- A secure directory in CircaBC
- Email.
Whenever possible, the information shared by electronic means shall be encrypted.
Involvement of Notified Bodies in Conformity Assessment Procedures-Article 53
This article is in conjunction with Section 4.3 of Annex VII.
Uploading of the Required Information by Notified Bodies
Notified Bodies shall perform the task of uploading the required information to a secured directory in CircaBC. This information uploading shall be done by using a pre-defined template.
Availability of the Information via National System
If compliance with requirements on notification of all other Notified Bodies is ensured, then a National System can be used to make the required information available.
Clinical Evaluation Consultation Procedure for Certain Class III and IIb Devices-Article 54
Notifying the Relevant Parties
Using a pre-defined template and uploading the required information to a dedicated secure directory in CircaBC, the Notified Bodies should notify the relevant parties.
Functioning of Expert Panels
Regarding the functioning of expert panels, the Commission will provide and manage a technical platform. Guidance on this technical solution to the relevant parties shall be provided.
Mechanism for Scrutiny of Conformity Assessments of Certain Class III and Class IIb Devices-Article 55
Uploading the Required Certificates and Other Mandatory Requirements
Notified Bodies shall ensure that they upload the required certificates and other mandatory information as referenced in Article 54.
Certificates of Conformity-Article 56
Availability of Certificates
Certificates will be either
- Made available upon the request
- Uploaded in the national system where required.
Once the EUDAMED functionality is available, the system can be used for uploading the certificates. However, this does not require the publication of the notice, indicating EUDAMED’s full functionality.
Application for Clinical Investigations-Article 70
Clinical Investigation Applications
Respective national procedures applicable to clinical investigations shall be used regarding applications for clinical investigations.
Notifying the Member States about Non-substantial Modifications
Before their implementation, the non-substantial modifications shall be notified to the Member States. This will be done through either
- National procedures
- By the procedure defined by the Member State.
Notification of Relevant Information and its Submission
- The notification of the relevant information must occur through the respective national procedures applying to the clinical investigations
- Regarding submission, a list of national contact points should be published on the Commission website
- At the national level, the new clinical investigation form developed under the MDR framework can be considered.
Electronic System on Clinical Investigation-Article 73
Issuance of CIV-ID by EUDAMED
EUDAMED2 has issued a unique single device identification number (CIV-ID) across the whole EU. This CIV-ID will be used in clinical investigations after the required information to the system has been submitted.
Using National Procedures for Issuance of CIV-ID
Use of CIV-ID should take place through national procedures applying to clinical investigations.
Facilitation in Issuing CIV-IDs
The process of issuing CIV-IDs can be facilitated through ad hoc exchange. Examples include:
- Regular teleconferences
- Collaborative platforms (e.g., CircaBC or other online platforms.)
Publication of CI and Other Respective Summary Reports
A dedicated and publicly accessible CircaBC directory should publish CI reports ad other respective summary reports. To avoid duplications, the MDCG should coordinate the publication process.
All clinical investigations should
- Take place through respective national procedures applicable to clinical investigations
- As per MDCG Guidance on safety reporting in clinical investigations.
Accessibility of the Required Information
From the date when the Commission ensures the availability of the respective EUDAMED module, or from the day when the EUDAMED becomes fully functional, all the sets of required information shall be accessible to the
- Commission
- Member States
- Public.
Clinical Investigations Regarding the Devices Bearing CE Marking-Article 74
Notification of the Relevant Information
This should take place through respective national procedures applicable to clinical investigations.
Substantial Modifications to Clinical Investigations-Article 75
Notification of the Relevant Information
This should take place through respective national procedures applicable to clinical investigations.
Corrective Measures to be taken by the Member States and Information Exchange between Member States-Article 76
Using CircaBC for Uploading the Information
Communicating the relevant information to the Member States and the Commission should e done using a pre-defined template and then uploading that information to a dedicated secure directory in CircabBC.
Information from the Sponsor at the End of a Clinical Investigation or in the Event of a Temporary Halt or Early Termination-Article 77
Communication of the Relevant Information
This should take place through respective national procedures applicable to clinical investigations.
Uploading the Relevant Information
This should take place through respective national procedures applicable to clinical investigations.
Sharing and Publication of CI Reports and Respective Summary Reports
Sharing and publication of CI reports and respective summary reports should be done using a dedicated CircaBC directory that is publicly available.
Coordinated Assessment Procedure for Clinical Investigations-Article 78
Application Procedure
The application procedure is mandatory for the participating Member States.
Recording and Reporting of Adverse Events that Occur During Clinical Investigations-Article 80
Reporting Procedures
Reporting of adverse events should take place through national procedures that
- apply on clinical investigations
- are following MDCG Guidance on safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745.
Periodic Safety Update Report (PSUR)-Article 86
Delivery of PSURs to Relevant Notified Bodies
Manufacturers should use appropriate means to deliver PSURs for
- Class III devices
- Class IIa devices
- IIb implantable devices to the relevant Notified Bodies.
Delivery of PSURs to the Manufacturers
- Notified Bodies shall provide PSURs and other corresponding evaluations to the manufacturers
- If the Competent Authority requests, then Notified Bodies should also make PSURs available to the Competent Authorities.
Reporting of Serious Incidents and Field Safety Corrective Actions-Article 87
Reporting the Serious Incidents to National Vigilance Systems
The manufacturers shall use the new MIR forms and the current FSCA system to report serious incidents and field safety corrective actions to the relevant national vigilance systems.
Transmission of the PSR Form
Manufacturers should also transmit the PSR Forms using the national vigilance systems.
Trend Reporting-Article 88
Submission of Trend Reports
Until it gets updated to the current MDR compliance system, the manufacturers shall use the current Trend Report system to submit trend reports to the national vigilance systems.
Analysis of Serious Incidents and Field Safety Corrective Actions-Article 89
Final Report Submission
Manufacturers will submit the final report to the relevant national vigilance system.
Communication with Other Competent Authorities
- Using a secure dedicated CircaBC directory for MDR devices, communication with other Competent Authorities shall occur
- The existing Eudamed2 system for NCAR should continue to apply to legacy and older devices.
Submission of Field Safety Notices
- Manufacturers will submit the field safety notices to the relevant national vigilance systems
- As per their national legislation, the Competent Authorities shall make these field safety notices publicly available.
Coordinating Competent Authority
About assuming its role of coordinating competent authority, the coordinating competent authority shall use email or any other suitable modes of communication to inform
- Other competent authorities
- The manufacturer
- The Commission.
Analysis of Vigilance Data-Article 90
Data Monitoring
Data Monitoring will become possible after the EUDAMED vigilance module becomes available.
Market Surveillance Activities-Article 93
Uploading the Summary Document
By uploading the summary document to a dedicated secure directory in CircaBC, the Competent Authority should inform the other relevant authorities.
Availability of Final Inspection Reports
By uploading the document to the CircaBC directory, the Competent Authority shall ensure the availability of final inspection reports to other authorities.
Availability of EUDAMED Functionality
EUDMED functionality will be available before the application of obligations. However, the Member States can still ensure public availability of the summaries on their websites.
Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety-Article 95
Notifying the Commission and the Other Member States
- The Member State shall use a pre-defined template and email to notify the Commission and other member states
- Whenever possible, the information shared by electronic means shall be encrypted.
Preventive Health Protection Measures-Article 98
Notifying the Commission and the Other Member States
- The Member State shall use a pre-defined template and email to notify the Commission and other member states
- Whenever possible, the information shared by electronic means shall be encrypted.
Good Administrative Practice-Article 99
Notifying the Relevant Notified Bodies and Responsible Authorities
- The Competent Authorities shall use email to notify the relevant notified bodies and responsible authorities
- Whenever possible, the information shared by electronic means shall be encrypted.
Transitional Provisions-Article 120
Application of Alternative Solutions to Legacy Devices
- Where appropriate, these alternative solutions can be applied to legacy devices. The availability of EUDAMED modules should be taken into account in this regard
- Registration of certificates issued as per the Directives should take place in Eudamed2.
Looking for a Reliable EUDAMED Provider?
TS Q and E is a well-known establishment in the medical device manufacturing industry. People experienced in the field of standards related to the medical device manufacturing industry are part of our organization. Under their expertise, TS Q and E are providing EUDAMED to medical device manufacturers around the globe. Get your exclusive EUDAMED solutions by TS Q and E by visiting our website today!
