Medical devices, what changes with the new European regulation

Surgical masks and lasers, programmable pacemakers with microchip technology, laboratory equipment for general use. These are just some examples of medical devices for which the new European Regulation (MDR 2017/745) – in force since May 26, 2021, with a 12-month delay due to the pandemic emergency, “enhances the collection of data relating to efficacy and security, strengthens post-marketing surveillance and guarantees 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. EU countries, also provides for the obligation to provide preclinical and clinical evidence, in order to obtain the CE marking. “In addition to obtaining an increase in safety and quality levels 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. it is useful that, at a European or national level, shared guidelines were defined that give space and allow for the structuring of virtuous collaboration paths between health institutions and companies “. The introduction of a traceability system for medical devices, unique at European level, will also favor and enhance the collection of consumption, durability and adverse event data and, consequently, strengthen their safety. 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 Crispel – 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 they 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. “Since all or almost all the devices will require a new certification by a Notified Body, the reduced number of these bodies could lead to longer times for placing on the market (time to market) and higher costs for the development of new DMs for the 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 due to rapid technological evolution – again according to Crispel – a collaboration between the certifying bodies and the business sector will be required. 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 rationalizing 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.