December 14, 2021

[FEATURED] Timelines And Deadlines For Stakeholders To Submit Information To EU’s Eudamed Database

IT system deadlines are renowned for being delayed. With speculation that the full implementation of the Eudamed medical device database will be postponed again, what will this mean for stakeholders?


The timelines and deadlines for uploading information into the upgraded Eudamed database have never been easy to understand. Indeed, the complex wording and cross-referencing in Articles 123 and 113 of the Medical Device Regulation and IVD Regulation, respectively, have perplexed even the experts and lawyers over the years.

Gradually, light has been shone on Eudamed’s intricate web of compliance conditions, and the Medical Device Coordination Group has issued guidance. But in parallel, it has also emerged that there are now likely to be problems with the European Commission managing to launch the full system on its 26 May 2022 anticipated go-live date (already itself delayed by some two years compared with the date originally set).

Do you like it?0
December 7, 2021

[FEATURED] Are Latest Challenges Threatening To Push Eudamed Launch Date Into 2023?

While nothing is official yet, it seems that the EU is likely to struggle to have two of the six Eudamed modules ready on time. Might this mean a further delay, or will the system be officially launched without them? 


The clinical investigations and the market surveillance modules of the new version of the EU medical device database, Eudamed, are reported to be causing the biggest challenges when it comes to setting up all six modules so that the entire database can be launched in 2022.

“We may even see Eudamed being launched officially with one or both missing, Ronald Boumans, senior consultant, regulatory affairs Emergo by UL, speculated.

Do you like it?0
May 3, 2021

EUDAMED3 Update: Two More Eudamed Modules Will Be Available Later This Year & Guidance on Alternatives Until the Remaining Three Modules are Released and the Database is Fully Functional

Author: Suzanne Broussard, PhD  | May 3, 2021  

By the end of the year, the first three modules will be accessible on the European medical device database, Eudamed3: Actor Registration, Unique Device Identifiers (UDI)/Device Registration, and Notified Bodies Certificates. The use of these modules is voluntary until all six inter-related modules are ready and Eudamed3 is fully functional. The existing Eudamed2 data base is being overhauled to support the Medical Device Regulations (MDR) and In Vitro Device Regulation (IVDR). 

For more information on the transition from EUDAMED2 to EUDAMED3 see our previous post, The European Commission Pledges Make the Different Eudamed Modules Available On A Rolling Basis.

The six EUMDADED modules are: 

  • Actors Registration 
  • UDI/Devices Registration 
  • Notified Bodies and Certificates 
  • Clinical Investigations and Performance Studies 
  • Vigilance and Post-Market Surveillance 
  • Market Surveillance 

The Actor Registration module became active December 1, 2020. The European Commission has officially confirmed that two more modules will be available by September 2021, the UDI/Device registration (second module) and Notified Bodies and Certificates (third module). Three more modules are scheduled to be displayed as soon as they are functional.  

(more…)
Categories:
Do you like it?0
July 27, 2020

The European Commission Pledges Make the Different Eudamed Modules Available On A Rolling Basis

Author: Dr. Suzanne Broussard

One of the recent announcements in the everchanging medtech sector is that the newest European database on medical devices (Eudamed 3) will roll out modules as they become functional. Eudamed 3 is the cornerstone for the new medical device regulations (MDR) and in vitro device regulations (IVDR) and is by all accounts an ambitious project.  

The version of Eudamed currently in use (Eudamed2) is a secure web-based portal designed to conduct effective market surveillance on medical devices through information exchange between competent Authorities and the Commission.   

Eudamed 3 will be dramatically different when it eventually rolls out. Eudamed 3 is designed to be multipurpose and function as a: 

  • Registration system 
  • Collaborative system 
  • Notification system 
  • Dissemination system (open to the public) 
  • Interoperable 

The original intention was that the newest Eudamed database would launch at the same time as the original MDR date of application. However, challenges in preparing the new updated system forced the delay by 2 years. Under this delay, Eudamed 3 will roll out on 26 May 2022.  

(more…)
Categories:
Do you like it?0
May 19, 2020

The Summary of Safety and Clinical Performance (SSCP) is a Required Part of Medical Device Regulation (MDR) 2017/745: Is Your Organization Ready?

Blast off for succession

Author: Suzanne Broussard

The Summary of Safety and Clinical Performance (SSCP) plays an important part of the very strong post-market follow-up required in MDR 2017/745 for implantable and class III medical devices. The SSCP is intended to provide healthcare workers and relevant patients access to current clinical data and other information about the safety and clinical performance of the medical device. 

SSCP is 1 of 2 yearly reports required of manufacturers to remain complaint under MDR to market medical devices in the European Union. The 2 reports are the Product Safety Update Report (PSUR) and the Summary of Safety and Clinical Performance (SSCP). The SSCP is not the same as the regular CER update. The SSCP needs to be updated when the PMCF and PSUR are updated as part of the ongoing lifecycle of these regulatory documents. 

The specific requirements of the SSCP can be found in Article 32 of MDR 2017/745. In addition, the European Union released MDCG 2019-9: Summary of safety and clinical performance, A guide for manufactures and notified bodies to provide guidance on the presentation of content in the validation of the SSCP.  

The guidance document outlines the minimum content required, and the manufacturer is encouraged to include additional information to enhance the readers understanding of the device’s safety and performance. Of course, the additional information cannot include promotional material and should not interfere with readability. Manufacturers should also keep in mind that the SSCP must be validated by notified bodies (NB); the guideline also provides information for NBs that the manufacturer can use to ensure that the SSPC includes all the relevant information. 

Another point to consider is that the target audience is healthcare workers as well as relevant patients. The European Commission considers relevant patients the target audience in special circumstances where the patient is directly engaged in the use of the device, such as implantable devices for which patients will be given an implant card and class III devices that are intended to be used directly by the patient.  

However, once the European Database on Medical Devices (Eudamed) database goes live May 26, 2022the SSCP can be accessed by anyone and everyone.  

(more…)
Categories:
Do you like it?0