Surgical masks and lasers, programmable pacemakers with microchip technology, laboratory equipment for general use. These are just a few examples of medical devices for which the new European regulation (MDR 2017/745) – effective from May 26, 2021, 12 months late due to the pandemic emergency, “enhances the collection of efficacy and safety data, strengthens post-market surveillance and ensures a high level of traceability of the device”, Underline the experts of Crispel – Roma Tre University Interdepartmental Research Center for Political-Constitutional Studies and Comparative Legislation.
The legislation, valid in all EU countries, also provides for theobligation to provide preclinical and clinical evidence, in order to obtain the CE marking. “In addition to obtaining an increase in the levels of safety and quality in the field of medical devices – explain Crispel – the new Regulation creates fertile ground for the birth of new scientific partnerships between researchers, health professionals, clinicians and manufacturers. In this regard, it would certainly be useful if, at a European or national level, shared guidelines were defined that would give space and allow for the structuring of virtuous collaboration paths between healthcare institutions and companies ”.
The introduction of a unique European-wide traceability system for medical devices will also favor and enhance the collection of consumption, durability and adverse event data. and, consequently, strengthen the security of the same. The systematic collection of data and the analysis of scientific evidence will also make it possible to compare the medical device with its equivalents and to determine clinically relevant differences, thus generating an efficient treatment path. “With a view to optimizing resources and health expenditure, these data – add dal Crispel – they can be used to improve the ability to govern technological innovation and clinical-scientific progress, ensuring an efficient allocation of resources “.
But the Crispel experts sound an alarm: “The new regulation on medical devices is not a regulation within everyone’s reach. The costs that companies will have to bear to adapt are not quantifiable to date but are still many, starting with the fact that it will be necessary to have a fixed structure that follows the post-sales surveillance and follow-up activities. It is then necessary to appoint a manager of the regulatory area and the services of the Notified Body also have costs “. And they add: “There is a small number of notified bodies compared to the amount of requests they are receiving and the number of fulfilments and requirements they are called upon to check. Their role is crucial but, at the moment, they are still too few ”.
Until a few weeks ago, only 20 bodies were accredited in the European database of ‘Nando’ Notified Bodies, of which just 2 in Italy. “So long as all or most of the devices will require a new certification by a Notified Body, the reduced number of such entities could lead to longer time to market and higher costs for the development of new DMs for manufacturers. Surely, at first the main objective of the manufacturers will be represented by the re-certification of the already existing devices with possible delay in the development of new innovative technologies ”underline from Crispel. Furthermore, since “the medical device market is characterized by rapid turnover for the rapid technological evolution – again according to Crispel – collaboration between the certifying bodies and the business sector will be needed.
But the concern also comes from the companies associated with Confindustria Medical Devices. According to a survey conducted by Medtech Europe, the European association of medical device companies, 80% of manufacturers are experiencing difficulties in starting or completing the compliance process and plan to not certify 15-20% of devices due to a process of rationalization of the product catalog according to an evaluation of the certification costs and market benefits. Some medium and small producers may exit the market and the system.