Early 2000s. The French regulator received numerous reports of accidents from women undergoing implantation of breast implants manufactured by the French manufacturer Poly Implants Prosthesis. The Agence française de sécurité sanitari des produits de Santé has initiated a series of safety checks, from which it emerges that the prostheses are defective: not only do they tend to break, releasing silicone particles (first problem), but this is a industrial type, not suitable for the purpose for which it is used (second problem). Following the verifications, in 2010 the company withdraws the product from the market and orders the recall of women undergoing surgery for the replacement of the implant.
But in the meantime, the years have passed.
In the absence of a network, tracing the path of each individual prosthesis, identifying it and withdrawing it, then going back to the patient for which it was used becomes a long and complex path. In the end, there are hundreds of thousands of women involved in this painful affair. During the stages of the process, the judiciary ascertains that the manufacturer had used inappropriate material for the production and that the notified body (the German Tüv Rheinland) had drawn up a false certification.
A new horizon
The PIP prosthetic scandal changed the world of medical devices forever. And not just from a regulatory point of view.
Also on the basis of the events related to those dramatic errors, the EU felt the need to establish a network to guarantee the traceability and post-marketing safety of medical devices on the model of the existing one for medicines.
Regulation (EU) 745/2017 (MDR), which became applicable on May 26, 2021, also responds to this need, in particular as regards the creation of Eudamed (European databank for medical device), the community database that must contain all data on medical devices on the market made available to all stakeholders (and not only).
Not a simple archive-catalog, but a single official reference, a tool for monitoring the entire life cycle of each individual device, with a view to transparency and data sharing that protects all the players involved.
New constraints in favor of safety
Eudamed is (or rather will be) an important example of how digitalisation can be used to protect the safety of medical devices.
The new Regulation imposes the obligation to assign an identification code (UDI) to each device, to record its data on Eudamed and to represent the UDI of the device on a carrier shown in the package. These are fulfilments aimed at identifying solutions to make the supply chain increasingly safe and efficient.
The advantages are manifold. Just think of achieving the objectives of product traceability, real-time monitoring by the competent authorities, simplification of purchasing policies and minimization of the number of errors and accidents associated with the use of the devices.
The central hub of the mechanism is Eudamed itself which, to meet the needs of the figures involved in the process, has been imagined with different interfaces, easily accessible and usable, each unique for interaction with the specific stakeholder.
A public interface will also be available, naturally limited compared to that designed for professionals, through which it will be possible to access information regarding the CE certification of each individual product, economic operators involved and the surveys that generated the related efficacy data. .
And here we come to the second fundamental aspect: MDR revolutionizes the overall vision of medical devices, made more complex and sophisticated, as well as the perception generated by these products among the public. Here then, in this context, Eudamed also becomes a reference for issues relating to effectiveness and the real core in which much of the new added value of the Regulation resides.
But today Eudamed is only half active. The first two modules, “UDI / device registration” and “Notified and certified bodies”, are available last October, while those relating to “Clinical investigations and performance studies”, “Post-marketing surveillance and surveillance” and “Surveillance of the market “are still being finalized and therefore can be filled in on a voluntary basis.
The European Commission has not provided precise deadlines regarding the date on which the latter will be published online, limiting itself to stating that it will happen when Eudamed is fully functional.
It is rather difficult to form a clear idea of future scenarios. This is an aspect that is generating quite a few concerns among companies in the sector. In an attempt to manage the impasse, pending the full operation of Eudamed, two documents have recently been published at the community level.
“MDCG 2021-08 Clinical investigation application / notification documents” provides templates of documents to be filled in and forwarded to the competent authorities of the specific Member State. The instructions for generating the CIV-ID code for clinical investigations on Eudamed are instead contained in the “MDCG 2021-20 Instruction for generating CIV-ID for MDR clinical investigations”.
Furthermore, MDCG 2021-1 was already issued last May, which contains some technical and administrative solutions, harmonized at European level, which can be temporarily adopted pending the full functioning of Eudamed.
In essence, the document provides that the databases of individual Member States will continue to be used. With the ministerial note of 16 December, the Italian ministerial database relating to the medical device surveillance system was therefore updated, to allow manufacturers and agents to register the devices in any case.
The current situation therefore appears paradoxical: the implementation of the solution that should guarantee the protection of the safety of medical devices is (indirectly) generating a dangerous transition situation that risks penalizing precisely these aspects.
An Italian success
In analyzing the situation, we cannot forget to emphasize that Eudamed brings with it considerations to be experienced as an important result for our country.
In February 2019, the Medical device coordination group (MDCG) chose to use our “National classification of medical devices (CND)” for its peculiarities of structure, purpose, usability and updating methodology, as a basis for the EMDN nomenclator of Eudamed.
In April 2021, the official listing proposal was presented by Italy, positively evaluated and authorized for publication (last May) and translation.