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.
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:
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 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.
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:
It is anticipated that the templates will be withdrawn as soon as the EUDAMED Clinical Investigations module becomes fully functional.
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).
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 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.
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.
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.
In Spring this year, updated technical documentation for the second and third EUDAMED modules – UDI / device registration and Notified Bodies & Certificates, was made available.
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.
The EU Commission’s updated timeline outlines the below milestones:
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.