Natale Bova

Natale Bova is Quality Assurance & Regulatory Affairs Director at Instrumentation Laboratory S.p.A. – a Werfen Company.  He has 25 years of experience in the IVD sector, both in the regulatory area and in the business management with responsibility for EMEA, LATAM and SEA territories.

Natale is the current chairman of IVD Regulatory Forum at Confindustria Dispositivi Medici, the Italian Association of Medical Device Industry. He has also been representing Werfen at Medtech Europe IVD Regulatory Affairs Committee in the past 15 years.

In order to keep them available to the health care system and to patients, more than 85% of IVDs will need to be updated in view of the new in vitro Diagnostic Regulation (IVDR) which is at risk due to the ongoing COVID-19 pandemic. The remaining IVDR transition time is not sustainable and requires attention and effective solutions. An exponential increase in swabs and serological tests, a continuously evolving demand for quicker and accurate diagnosis as well as for tests monitoring respiratory functions and diagnosing complications are some examples of the high pressure that the IVD sector had to face and has been responding to since the beginning of the COVID-19 pandemic. IVD manufacturers have been on the frontlines of this fight, supporting Europe’s health services. They have invested in production, logistics, and expertise support to meet this challenge and have put research and innovation front and centre in order to define ways to identify the virus with increasingly effective methods. COVID-19 is monopolising the scene, increasing the already existing challenges for the sector in implementing the new IVDR. It has diverted the resources of companies, institutions, and all parties involved, with the result of slowing down implementation. The remaining transition time for the IVDR is no longer sustainable. The IVDR is scheduled to enter into full legal application from May 26 th , 2022 – in merely 18 months from today. The key elements of the regulatory system have been substantially upgraded, especially the requirements for clinical studies and post-marketing ones, the role of notified bodies, and a new risk classification system. However, the structural elements of the new regulatory framework have not yet been prepared. The guidance documents for new processes, such as on clinical evidence, are lacking. Expert panels and expert laboratories that are necessary to certify...