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EUDAMED roundup | What’s happened and what’s next

Posted on by Congenius

The creation of a European database for registering certified medical devices is regarded as a cornerstone of the EU MDR and IVDR. Ultimately, the purpose of EUDAMED is to provide a “living picture of the lifecycle of medical devices” placed on the EU market.

Originally planned for completion in 2020, EUDAMED’s progress has been thwarted by COVID-19 restrictions – which prevented many on-site audits, and a shortage of notified bodies designated to operate under the MDR and IVDR.

With the EU Commission’s recent publishing of an updated EUDAMED delivery timeline, our CEO Jörg Dogwiler recaps what’s happened so far regarding the EU medical device database and summarises what’s to come in the months ahead.

First, a quick recap | What is EUDAMED?

By integrating different electronic systems to collate and process medical device information, the EU medical device database (EUDAMED) aims to improve the overall transparency of information for the public and healthcare professionals, and enhance coordination between the EU and Member States.

Once finalised, EUDAMED will be comprised of six modules:

  • Actor registration
  • Unique Device Identification (UDI) and device registration
  • Notified Bodies and Certificates
  • Clinical Investigations and Performance Studies
  • Vigilance and Market surveillance

December 2020 | Actor registration

On 1 December 2020, the European Commission made the Actor Registration module available to Member States and economic operators.

The first of the six EUDAMED modules, 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 then guarantees an EU-wide unique identification for economic operators.

Every economic operator – including EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers, must register as an actor in EUDAMED and provide the required information.

As part of the Actor Registration Request, all actors must upload a signed declaration on information security responsibilities. To register in EUDAMED, non-EU manufacturers must also have an active authorised representative and submit a Mandate Summary Document with the registration. For an actor already registered in EUDAMED, all persons who intend to act on behalf of this actor need to enter an access request.

February 2021 | Processes shared for managing legacy devices and IVDs in EUDAMED

February 2021 brought with it new information from the EU Commission regarding how legacy medical devices and IVDs will be managed in EUDAMED.

The term “legacy device” in this context covers any medical device or IVD with a valid CE Mark certification under the MDD, that may remain on the EU market after the MDR and IVDR application dates, for as long as their existing CE Marking remains valid.

Additional processes were laid out for EUDAMED registration for these products, including Unique Device Identification (UDI)-related requirements and considerations. The new information built on the April 2019 guidance on EUDAMED registration for legacy devices.

May 2021 | MDCG issues interim templates as EUDAMED modules delayed 

With EUDAMED delayed and its Clinical Investigations and Performance Studies module outstanding, in May 2021 the MDCG prepared an interim set of documents to support the clinical investigation procedures under MDR.

The documents include:

  • the clinical investigation application/notification form (containing, for the most part, identical data fields to those being developed for the EUDAMED Clinical Investigation module)
  • addendums for additional investigational devices, comparator devices and investigation sites
  • an appendix of clinical investigation documents to attach to submissions
  • a checklist of general safety and performance requirements, standards, common specifications, and scientific advice

It is anticipated that the templates will be withdrawn as soon as the EUDAMED Clinical Investigations module becomes fully functional.

July 2021 | MDCG answers questions on EUDAMED actor registration

With a growing number of queries regarding the EUDAMED Actor Registration module, in July 2021 the MDCG published a Q&A on requirements for EUDAMED registration of actors other than manufacturers, authorised representatives, and importers subject to the obligations of MDR and IVDR. The Questions and Answers document also clarified the circumstances for which an Actor ID is issued as opposed to a Single Registration Number (SRN).

July 2021 | Guidance on UDI integration within a QMS

In the same month, the MDCG published a guidance note on the integration of the UDI within an organisation’s quality management system, including UDI data to be provided to EUDAMED.

The guidance contains considerations for integrating the UDI obligations within the different areas of a QMS covering design and development, product documentation and retention, production and process, serious incidents and field safety corrective actions, purchasing controls, documentation and records, enterprise resource planning, and UDI data to enter into the EU medical devices database.

October 2021 | Unique device identification (UDI) and device registration & Notified Bodies and Certificates modules released

October 2021 saw the release of the second and third EUDAMED modules – regarding UDI / device registration, and Notified Bodies & Certificates.

However, according to MDR, the EU Commission will not be able to mandate the use of the released modules until EUDAMED is fully functional. Until then, data entry into the system by Economic Operators and Notified Bodies remains voluntary.

December 2021 | EU Commission sets rules for applying MDR to EUDAMED

In December 2021, Commission Implementing Regulation (EU) 2021/2078 was passed, laying down rules for the application of the EU MDR with regards to EUDAMED. The regulation, which took effect from 19 December 2021, covers EUDAMED set up, maintenance, accessibility, and cybersecurity.

December 2021 | MDCG releases template for substantial modification of clinical investigation under MDR

With the industry still awaiting EUDAMED’s completion, the MDCG continued to add to their series of clinical investigation application/notification documents to support clinical investigation procedures with respect to MDR.

MDCG 2021-28 provides a template for the substantial modification of clinical investigations under MDR. Whilst this template will likely be withdrawn once the EUDAMED module for clinical investigations is fully functional, in the meantime the template is intended to be facilitative – including the same data fields as the EUDAMED system in development insofar as possible.

April 2022 | Updated technical documentation made available for second and third EUDAMED modules

In Spring this year, updated technical documentation for the second and third EUDAMED modules – UDI / device registration and Notified Bodies & Certificates, was made available.

July 2022 | MDCG releases practices and solutions for use until EUDAMED fully functional

In early July this year, the EU Commission released an updated timeline for EUDAMED’s completion that communicated a delivery date of Q4 2023 for the Minimum Viable Product (meaning that the system developed will implement at least the minimum MDR requirements and will allow competent authorities and all stakeholders to comply with their legal obligations).

In the interim, the MDCG has released harmonised administrative practices and alternative technical solutions for IVDR, to utilise until EUDAMED becomes fully functional. MDCG 2022-12 provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during EUDAMED’s absence. In particular, the guidance addresses cases where the exchange of information would be difficult or impossible to achieve based on the corresponding provisions within Directive 98/79/EC.

So what’s next for EUDAMED?

The EU Commission’s updated timeline outlines the below milestones:

  • Q4 2023 | End of EUDAMED Minimum Viable Product development for all six modules
  • Q1-Q2 2024 | Independent Audit to be carried out
  • Q2 2024 | Audit results will be presented to the MDCG
  • Q4 2024 | Will mark the end of the 6-month transitional period after publication of the notice in the OJEU. The use of EUDAMED will become mandatory regarding obligations and requirements related to Actors, Vigilance, Clinical Investigation & Performance Studies, and Market Surveillance modules
  • Q2 2026 | Will mark the end of the 24-month transitional period after publication of the notice in the OJEU. The use of EUDAMED will become mandatory regarding obligations and requirements related to UDI/Device and Notified Bodies & Certificates modules

Here at Congenius we’re optimistic that the release of this timeline post-pandemic marks the end of further delays to EUDAMED’s finalisation, but we’ll certainly keep you posted of any further developments as they happen over the next months.

Should you have a challenge related to EUDAMED or MDR / IVDR compliance, please do get in touch. Our Regulatory experts are ready and happy to help.

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