The European Regulations on MD and IVD and the “Urgent Need for Action”: Will This Mark the Beginning of the End of the New Approach?

We are now in year 8 of our coexistence with the (no more) new European Regulations 2017/745 and 2017/746 that, as of their  coming into force on 26 May 2017, keep changing dramatically the European regulatory landscape of medical devices and in vitro diagnostics, still driving forward for this sector the regulatory model defined as “New Approach”.

This model had been already implemented as of the early ’90 with the old Directives, with the aim of promoting product standardization  to the safety and quality requirements, facilitating at the same time free exchanges in the European market, aiming at harmonizing minimum basic safety requirements and product performance, but leaving manufacturers free to decide how to meet them, and therefore leaving them with the responsibility of providing evidence to support their operations – a bit in contrast with the traditional “authorization” approach, where an authority releases marketing authorizations directly, after verifying that all legal requirements were accurately complied with just as requested by regulations.

The voice of the European and national associations

Today, the biggest European and national associations of the biomedical sector have loudly pointed out (not for the first time) that although 8 years have elapsed on the calendar as of 26 May 2017, the reality is that we are still in a full transition phase, due “serious implementation issues”, serious criticalities in the implementation of the provisions of these regulations.

Therefore, 40 associations signed an open letter where they stated that a series of concrete and immediate measures should be adopted to face the deadlock and uncertainty that, now persisting for all these years with no end on the horizon, risk to become a “new regulatory regime”, rather than a transitory one, for all manufacturers and even more for patients.

This is because regulators’ timelines, as it is well known, are very different from the needs of the market, of technological innovations and, above all, of the “health’s needs” of citizens (as 2020 should have taught to us).

The open letter, addressed to the outgoing European Health Commissioner Stella Kyriakides, is only the last of many reminders that were submitted to Europe in these years.

The letter’s contents

The “novelty” in the contents of this letter is perhaps the level of details with which the signing associations are proposing the measures to be adopted, in order to prevent or slow down the most dangerous consequences of this situation, (since long) identified in a risk of a market stock-out of products necessary to cover the needs of citizens; in the impossibility, especially by small- and medium-sized companies, to support the burdens that this level of requirements would imply; and in the general loss of attractiveness of the European market that is leading, and will lead more and more companies to prefer investments on markets with clearer and smoother regulatory procedures (the letter suggests to “reverse the exodus of innovation from Europe”).

Briefly (for more details, here is the integral text of the letter), there are three areas of action for which proposals have been submitted: a short- and medium-term action area, one with actions to be adopted on an ongoing basis, and one where more specific and urgent main proposals are explained, that are to be adopted immediately.

Central Entity, More Predictability and CE Certificates with no validity expiry

First of all, there is the request (more than a proposal) to institute a central entity dedicated to the management and supervision of the whole European regulatory system of this sector, especially ensuring coherence between the various European legislations during their evolution.

Then, there is a request of more predictability on times and costs of the new evaluation pathways for the conformity of products.

No need to stress that these are the most relevant “items” that are considered in the companies’ market strategies, therefore it is not acceptable that their extent is known only when a product’s development project is in an advanced phase (as in the case of the costs, since the NBs require to examine several product information before issuing a quotation, and this information must have been already prepared by the companies), or even along the way, (as in the case of the time, considering the almost total lack of defined times by the various NBs, for assessments, re-assessments, waiting lists, etc.).

Another very explicit request is to eliminate the “expiry” of the validity from the CE certificates , now of 5 years at most, to avoid a step that most of the times is only bureaucratic, since it is not related to actual changes to the product, and involving therefore an additional, but little helpful, workload (and costs) for companies as well as NBs.

Final considerations

Examining all these proposals, a consideration emerges, from a while ago, when in September 2012 the first draft of the new MD and IVD Regulations was proposed. Not a Directive anymore, but a kind of text to be applied as it is, uniformly, in all Member States, with the regulator’s goal being, among others, the harmonization of the rules for the marketing of these products to guarantee common quality and safety standards, exercising at the same time a central reinforced control on NBs as well as on the safety of products circulating on the territory.

On the companies’ side, today’s proposals ask for: the institution of a central authority for the governance of the whole regulatory system, a certainty in the times, costs and methods of the conformity procedures, the cancellation of the procedure for the CE certificate renewal.

Going out from the medical device world to enter the pharmaceutical regulatory system, we can see that the latter has always adopted a more traditional approach with an authorization “from above”: thus, in EU we have EMA,  coordinating all national regulatory agencies , directly responsible of some authorization procedures.

Still in the pharmaceuticals sector, the fees to be paid to the authorities for authorization or variations procedures are usually established by a national decree, along with the timetable (that can be longer based on any suspension in the procedure).

Finally, the medicinal products marketing authorizations are subject to the obligation of a single-time renewal, 5 years after the release of the first authorization, after which its validity is unlimited (until given conditions are met).

So, the question is: in the outburst of revolutionizing the medical regulatory system aren’t we all (regulators as well as stakeholders) perhaps wishing, without saying, the fading of the New Approach?

Written on 24/10/2024 by Silvia Petroni