MD and IVD European Regulations, debate continues on urgent review
The latest call to the European Commission by all most important European association of the biomedical sector (read here our article on this) for an urgent review of the European regulations on medical devices and IVDs, was soon followed by a series of interventions by several stakeholders, thus creating an intense exchange on the topic, underlining the relevance for all of taking concrete measures in the short term.
Review of Regulations 2017/745 and 2017/746
First of all, in chronological order, there was the joint motion for a resolution on the need of an urgent review of both Regulations 2017/745 and 2017/746 (here its integral text.)
The motion was submitted by all Parliament groups, and points out that, in spite of all the “good intentions” of the Regulations, their implementation is causing great difficulties, especially to small- and medium-sized enterprises, for which the transition of their products toward the new Regulations is particularly difficult due to the complexity of the new regulatory procedures, also accompanied by huge uncertainty due to a lack of harmonisation, and often of transparency, in the procedures, in the timelines and in the costs between the different Notified Bodies.
All these aspects have a strong impact on the market access of many products, and are therefore causing, in some cases, serious shortage of some devices and, consequently a difficulty by patients to access appropriate care.
Technological innovation
Along with this – Parliament groups have pointed out – in this way technological innovation, so relevant for this sector, is slowed down, since there are no suitable options for the assessment of innovative products, that clearly cannot be assessed with the same criteria adopted for more traditional products.
For this reason, the Commission has been invited to implement urgent measures, using any “legislative and non-legislative tools”, to overcome the deadlock created in the sector, acting on the same aspects already brought to the attention of the Commission by trade associations: increasing harmonisation and transparency in the Notified Bodies assessment procedures, making timelines and costs to access the market more certain, eliminate any bureaucratic-only procedures to unburden the operations of companies and Notified Bodies, creating dedicated pathways to support small- and medium-sized enterprises and those with technologically innovative products.
The reaction from Medtech Europe
The Parliament resolution has prompted immediate reaction by Medtech Europe, that has declared their full support to the resolution, and has confirmed their availability to work together with the European Commission on these common goals.
On the other hand, the reaction of national competent authorities (HMA core group on medical devices) was less enthusiastic. In a letter to the General Director of Health and Food Safety (DG SANTE), they have pointed out that, although agreeing with the detected critical issues, they believe that tools for immediate implementation are not appropriately suitable to solve them, since this kind of problems should not be evaluated via “abridged” pathways, in order to prevent the introduction of processes and requirements that were not adequately considered.
The position taken by the Notified Bodies
Notified Bodies also made their press release via the association TEAM-NB, to take their stand on the topic.
They said they are essentially in favour of the adoption of tools to harmonise the procedures, of the deletion of some purely bureaucratic aspects, and of the publication of further more specific guidance to solve and harmonise some aspects considered as critical during assessments.
However, they have also pointed out that, in many cases, the extension of their time for assessment is a consequence of the delay with which manufacturers provide information and responses during conformity assessment procedures; such delays, they fear, can cause criticalities, especially close to the deadline of the new transitory period (2027 and 2028).
Therefore, they believe that any tool implemented, any guideline adopted should not lead to a further extension of these timelines.
What emerges?
Based on this picture, it becomes clear that, essentially, there is just one certainty: the fact that, after years of transition, it is no more possible to wait further to solve in a concrete and final way the issues that have been showing the weaknesses of the new Regulations from the beginning, and that today, more than 7 years after their entering into force, are still open.
