Regulation 745/2017 (MDR) lists among its primary objectives the improving safety standards and expanding access to medical devices by patients and healthcare professionals. To achieve these goals, Europe countries have set out to attribute common rules to themselves, harmonizing a discipline which, fragmented and uneven, risked creating barriers to the market and the flow of data. However, the introduction of the new regulatory framework has dealt heavy blows to the system, which is struggling to reorganize itself to meet the new obligations.
What is happening, in fact, is that an initiative introduced to protect citizens paradoxically risks penalizing them. This is occurring, moreover, at an extremely critical historical period, in which medical device companies are also being called upon to deal with the payback storm, which threatens to overwhelm much of the industry.
The unfortunate international economic situation adds to this discouraging picture the crisis in diplomatic relations with some of the raw material supplier countries and the consequent disruption of the supply chain.
The alarming picture thus legitimizes serious concerns about the fate of innovation and for the fate of individual patients, who will necessarily have to face serious shortages if appropriate solutions are not identified quickly.
The survey “Analysing the availability of medical devices in 2022 in connection with the medical device regulation implementation” carried out by MedTech Europe (a trade association of European medical device manufacturers) shows that many of the companies in the industry are considering reducing their portfolio products by as much as 33 percent. A phenomenon that would have repercussions significant on healthcare systems and would remove many essential products from the market.
The most fragile realities are represented by small and medium-sized enterprises, particularly represented in our country and penalized by a mechanism of certification even slower than for larger companies.
The capacity of notified bodies
One of the key junctures of the issue is the number of Notified Bodies, which is insufficient to cover the requests for issuing new certifications within the timeframe set by the Regulation. On January 6, the European Commission adopted a proposal to extend the time interval given to companies to obtain certification of medical devices beyond the original deadline of May 26, 2024.
This decision was made in light of the congestion of outstanding requests that had been created, as well as the cumbersome nature of the transition from certificates for devices existing devices to the new MDR rules. That something was not working correctly had been sensed: suffice it to say that last October the certificates MDRs issued were 2,000 and that the goal would be to reach 23,000 by May 2024.
For so-called legacy medical devices (certified before May 26, 2021, the date of full implementation of the new regulations) the deadline was extended to Dec. 31 December 2027 for products in the highest risk classes and to December 31 December 2028 for those with medium and low risk. The European Commission’s proposal includes the elimination of the cut-off date for the sale (or, better said, “clearance”) established by the Regulation: this will allow prevent restriction of access to medical devices, without limiting their safety standards. The proposal is currently under consideration by the European Parliament and Council, which will evaluate it through an accelerated co-decision procedure.
The node of sanctions
The penalty regime introduced under the new legislation is strengthened compared to that in force in the directive system. The regulation delegates the individual states members to establish the sanctions. In Italy, compliance with MDR was achieved through the issuance of Decrees 137 and 138 of August 5, 2022. Article 27 of Decree 137/2022, in particular, introduces sanctions that impact mainly in the areas of clinical investigations, other types of data collection, and the Person Responsible for Compliance of the regulations. A further noteworthy aspect is that the sanctions also affect importers and distributors.
An evolving database
One of the key elements for the operationalisation of the new regulatory framework is represented by the Eudamed database, the implementation of which appears to be running far behind schedule. In fact, the regulations envisioned full entry into operation by May 26, 2021. Eudamed will consist of a public site and six interconnected modules: to date, only three only three have been made available. Estimates call for completion by 2024.
While the compilation of such a database remains temporarily on a voluntary, there is also the question of how to deal with the issue of classification, i.e. how medical devices are to be classified within such a repository. The new regulatory framework identifies the nomenclator to be used for inclusion in the database of individual products, the European medical device nomenclature, Emdn.
Despite the fact that this is a tool made by taking the Italian classification as a model role, there does not seem to be much advantage for our companies in this respect either. In fact, manufacturers are still required to verify the appropriateness of the classes assigned to their products, according to a process that involves a significant expenditure of time, energy and financial resources.
However, experts are very cautious on this point: the development fine-tuning of Eudamed, with all its associated aspects, is predictably complex but critical to improving the safety of medical devices, access to their use and the quality of the system in general.
What will become of innovation…
The difficulties that are bearing down on the medtech industry are discouraging the investors and manufacturers themselves, who are serious about considering opportunities for expansion to other markets. After years in which the European landscape was highly attractive, it seems a deprioritization of the EU market is looming. Already significant is the number of companies that have chosen, since that May 26, 2021, to launch new medical devices outside the European Union.
Analysts warn: other countries (one among them the United States) could reap without hesitation the fruits of the impasse. A prospect, this one, until recently completely unimaginable.