Oliver Bisazza

Oliver Bisazza joined MedTech Europe in August 2017. He comes to us from Medtronic, where he served since 2014 as Director of Regulatory Policy for Europe, the Middle East and Africa. In this role, he was also highly active within MedTech Europe, leading and participating in numerous committees and stakeholder alliances. 

Prior to joining Medtronic, Oliver was Technical and Regulatory Affairs Manager at COCIR, the European association for the radiological, electromedical and healthcare IT industries. His career in Brussels started with 4 years of progressively responsible regulatory roles within EDANA, the industry association for the nonwovens and related industries.

A dual national of Australia and Malta, Oliver has a Masters degree in Economic Sciences from the University of Wales, where his research focused on European legislative systems and their preparedness for emerging public health threats.

One year has now passed since the ‘new’ EU IVD and medical devices regulations entered into force. Since Day 1, the medical technology industry has been working at full capacity to achieve and maintain maximum possible readiness. While I’d love to claim the same for all other essential elements of the new regulatory system, progress has so far been too slow and piecemeal. Let me repeat that: To the fullest extent possible, industry is ready, but the system is not. Time is running, and it’s running fast. Unless all essential elements of the new system are in place soon, time could very well run out. It could run out for our industry, for sure, but also for the hospitals, laboratories, patients and physicians who rely, every day, on life-saving and life-transforming medical technology products. Why, you ask? Surely the new EU regulations were designed to increase patient safety, better protect public health, and ensure both legal certainty and an innovation-friendly environment, right? Yes, those are the goals, but as we have been saying from the very beginning , these benefits can only be achieved if the necessary building blocks of the new regulatory system are in place early-on . Well, one-third of the transition period is now gone for medical devices. There is a little more time for IVDs, but on that front the work is even more daunting. Time running out to put the system in place Our regulators have been working as fast as they can, despite systemic resource constraints , it’s true that a few pieces of the system have started to emerge in the past 12 months. However, a huge amount is still outstanding, and is needed for manufacturers to fully comply by the dates of application. For instance, to date, we still have none of...
We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike. Last week, at the Association of the European Self-Medication Industry’s (AESGP) regulatory conference, I presented MedTech Europe’s vision to the Heads of EU Medicines Agencies. In most Member States, these agencies are the home of our IVD and medical device competent authorities, meaning that the heads of these agencies bear ultimate responsibility for the successes (and failures) of our present regulatory journey. Building on MedTech Europe’s political messages for a successful IVDR and MDR implementation, our messages to the regulatory leaders are: 1) INVEST! The new Regulations are 2-3 times larger than the former Directives and they’re more detailed and burdensome, for business and for regulators. Good regulatory practice states that authorities need expertise and resources proportionate to the legislation they implement. After 50+ years of EU pharmaceutical legislation, most of our industry’s competent authorities sit in agencies with excellent pharmaceutical expertise. Several even have respectable medical devices’ expertise. Only a few have noteworthy IVD expertise and nearly none have ‘enough’ general expertise and (human) resources to properly implement the new Regulations. To their credit, several agencies are staffing up or would like to. Not many have received enough support – financial or political – from their leaders in the Ministries. Where support exists, it’s often challenging to find suitably trained people, especially in IVDs and emerging technologies. This needs to improve and quickly. Industry and Notified Bodies are already recruiting the best people they can find, and national authorities will struggle to compete in this well-tapped labour market. If staffing up...
At long last, the date has arrived. Organisations who aspire to be Notified Bodies under the European IVD and medical devices regulations can submit their applications as of yesterday, 26 November 2017. In order for the new regulatory system to function as intended, it is essential that these assessment bodies be up-and-running as early as possible. This will impact a vast majority of the 500,000 medtech products already on the market as well as new ones. It includes in particular, IVDs, which need Notified Body oversight for the first time. What happens next? Applications are open. The application forms and the necessary Implementing Act were all published on-time. Organisations who apply will be treated on a “first come, first served” basis. Their applications receive a completeness check and preliminary review by their responsible national authority, and if all is in order they undergo an on-site audit. This process is called a “joint assessment,” because it involves both the European Commission and experts from at least three different national authorities. On-site visits, phone calls, paper reviews and more all happen to confirm that the organisations have the necessary competence and expertise to check the safety and performance of IVDs and medical devices. When that happens successfully, the respective national designating authorities will give these organisations their license to operate as Notified Bodies in the IVD or medical devices field. Who is applying? Demand for Notified Bodies in this sector is at an all-time high, and is expected to increase substantially, especially for IVDs. The vast majority of our existing Notified Bodies are therefore expected to apply to remain Notified Bodies under the new Regulations. We also expect that new players will seek to enter this space in the future, though some longstanding Notified Bodies may cease to exist. Many well-established Notified...