Nocco (Aiic): ‘Possible shortage of medical devices’

“We are concerned about the survey whose data were submitted to us by MedTech Europe, the association that brings together all European manufacturers of medical devices”. The fear is that “the implementation of the new regulation on medical devices – MDR 2017/745 – instead of creating balance, safety and regulation, could generate a shortage of products in European health services, with the consequent lack of responses to patients’ needs. Obviously it was never the intention of the European legislator to create periods of unavailability, but certainly today the limited number of notified bodies and the complexity of the authorization processes can affect citizens, who can see a reduction in safe and authorized devices placed at their disposal “. Thus Umberto Nocco, president of the Italian Association of Clinical Engineers (Aiic), against the data of a survey that MedTech Europe has published, analyzing the availability of devices in relation to the implementation of the New Regulation. 475 companies took part in the survey, including 102 multinationals and 373 small and medium-sized enterprises. Overall, the panel of survey respondents represents 60-70% of the European market. The survey indicated some concise conclusions: authorization certificates have not yet been issued for about 85% of the more than 500,000 devices previously certified under the previous directives on medical devices. 54% of MedTech Europe interviewees stated that they have no intention of transferring part of their portfolio within the provisions of MDR 2017/745: all product categories are therefore currently affected – little or much – by potential interruptions of The other data from the MedTech Europe survey apparently concern the productive world more than that of citizens and patients. Small and medium-sized enterprises in the sector – and here Italian companies are particularly represented – have to face more difficult challenges in the implementation of 2017/745 than large companies: a share of companies, estimated at between 15% and 30% of brands small and medium-sized, does not yet have access to a designated notified body (those responsible for authorizations for entry into the market). Finally, in a reading of the “international production scenario”, the New Regulation 2017/745 currently appears as a disincentive – rather than a support – to the launch of medical device innovation in the European Union: about 50% of respondents are ‘deprioritising’ the EU market as the chosen geographical area for the first regulatory approval of their new devices. “It is obviously not the task of health technology professionals to enter into the merits of European regulations or their application path, but we can only feel a certain perplexity about the consequences that the New European regulation 2017/745 is generating in Italy and throughout Europe “, observes Nocco.” Overall – continues President Aiic – we believe that these data should be taken seriously by institutions and agencies The world of production is expressing a criticality which, although not the only point of view to be taken in c This consideration cannot be ignored if the health technology sector is to be brought into a phase of greater transparency, safety and regulation “. “In conclusion – underlines Nocco – we believe that the world of citizens and professionals must also be involved in the overall dialogue, in such a way as to jointly reach more certain times and ways of implementing the New European regulation that do not penalize health systems and those productive guaranteeing rules and safety “.