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.

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...