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 

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.  

Actor Registration Module 

“The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN).” 

The SRN is required under MDR and IVDR and allows economic actors to be clearly identified throughout the European Union. In addition, submitting information related to the device to Eudamed as well as submitting an application for conformity assessment to a Notified Body require a SRN. 

Under MDR, all medical device actors, including manufacturers, must register in the updated EUDAMED3 database from May 26, 2021. This includes devices with CE marking under both the directives (MDD 93/42/EEC and IVDR 98/97/EC) and newest regulations (MDR 2017/745 and IVDR 2017/746) that are replacing them. Care should be taken not to duplicate registration as it will trigger a duplication check requiring justification. 

Legacy device manufacturers are also required to register in order to facilitate post-market surveillance, conduct field safety corrective actions, and manage adverse events. However, legacy devices requirements are different, and the European Commission provides detailed guidance on how legacy devices will be identified in Eudamed and how their different device identifier will be generated and assigned. 

The European Commission Medical Devices website on Eudamed currently has the following technical documents, videos, and infographic to support registration of all devices.  

Fully Functional Eudamed 

The Medical Device Coordination Group Document (MDCG 2020-15) foresees the launch Eudamed with all six modules fully functional in May 2022. Use of the modules is volunteer until that full launch. However, while actor registration in still volunteer, the members of the MDCG strongly encourage its use by all relevant actors on their territories, including the use of the SRN by actors as stipulated in the MDR (e.g., indicating the SRN on certificates). One reasons it that actor registration is a prerequisite for accessing Eudamed.  

Note that manufacturers still must maintain compliance with MDR and IVDR regulations even though Eudamed is not functional. MDCG provides guidance on how manufacturers can accomplish compliance. 

Exchange of Information Until Eudamend3 is Launched 

MDCG endorses a guidance document that “describe harmonised administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.” This guidance addressed cases in which the exchange of information would be difficult, or even not possible, based on the corresponding provisions in MDD and Active Implantable Medical Devices (AIMDD).  

MDCG 2021-1 
Guidance on harmonized administrative practices and alternative technical solutions until Eudamed is fully functional 

The MDCG 2021-1 guidance document provides helpful tables that cross reference different articles within MDR and provide guidance on how to meet these requirements in the absence of a fully functional Eudamed. Indeed, 28 pages of the 31-page document presents a table that clearly notes within the article which actor is responsible for what type of information exchange. Previsions related to the use of Eudamed (as referred to in Art. 123(3)(d) MDR) are side by side with the alternative solutions to submit and/or exchange information (as required under the MDR).  

One solution that is referenced throughout MDCG-2021-1 is the use of the European Commission’s collaborative platform the Communication and Information Resource Centre for Administrations, Businesses and Citizens, referred to as CircaBC. This website is used for the distribution and management of information by a variety of sectors. An example is both sponsors and member states using the secure folders in CircaBC for reports and certificates for clinical investigations. It is unclear how the documents will be handled once Eudamed is fully functional. Will everyone need to upload the document to Eudamed?  

Moving Forward 

The deadline for MDR 2017/745 compliance is May 26, 2021, and IVDR 746/2017 compliance is May 25, 2021. 

If your organization needs support getting your technical documents ready for the transition to MDR or IVDR during this ever-changing landscape of medical regulations, Criterion Edge has the expertise and bandwidth to work with you and get the job done. Please reach out to us for a free consult. 

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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.  

The SSCP should always have 2 parts. One part for healthcare professionals, and a second part for patients. Ensuring the SSCP includes a writeup that targets both audiences requires medical writers with strong technical writing skills and writers that transform complex scientific information into easy to read content.  

The SSCP has 9 sections that need to be addressed: 

1. The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN (single registration number) 

2. The intended purpose of the device and any indications, contraindication and target populations  

3. A description of the device, including a reference to previous generations(s) of variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device.  

4. Information on any residual risks and any undesirable effects, warnings and precautions 

5. The summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up 

6. Possible diagnostic or therapeutic alternatives 

7. Suggested profile and training for users 

8. Reference to any harmonized standards and CS applied 

9. Revision history 

While the SSCP provides a plethora of information, MDCG 2019-9 clearly states that SSCP is not intended to: 

  • give general advice on the diagnosis or treatment of particular medical conditions, nor 
  • replace the instructions for use (IFU) as the main document that will be provided to ensure the safe use of a particular device, nor 
  • replace the mandatory information on implant cards or in any other mandatory documents. 

Unlike the Post-Market Clinical Follow-Up (PMCF) plans and report, the SSCP is only required for implantable and class III medical devices. Custom made and investigational devices are the exceptions that do not require an SSCP.  

The data needs to be presented in an objective manner that clearly summarizes both favorable data and unfavorable data. Putting together an SSCP that includes the devices benefit to risk, diagnostic and therapeutic alternatives as well as the specific conditions in which the device is considered can be a real challenge. All SSCPs need to be entered into the Eudamed. The fact that SSCPCs will be available to the public as soon as Eudamed is updated and goes live in 2022 puts even more pressure on getting the SSCP right.  

Criterion Edge works with experienced medical writers to help ensure that the critical SSCP elements, such as the source of quality data, are correctly disclosed in the SSCP. Chat with us about our experience with SSCPs.

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[WEBINAR] How to Assess Your CER for MDR Readiness: Part 2: Clinical Data Sources, Risk-Benefit Analysis and Overall Analyses and Conclusions

In this second installment of a 2-part webinar series on Wednesday May 12, 2021 at 11AM PST / 2PM EST, we will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, and help you identify possible gaps for mitigation prior to submission to regulatory authorities.

Attendees are eligible for a free consultation and scan of their CER. Spots are limited – click to register for this free webinar.