New EU Regulations on medical devices and in vitro diagnostic medical devices (IVDs) mean all stakeholders, including manufacturers, competent authorities, and Notified Bodies – need new knowledge and skills.
The Regulations seek to harmonise requirements, capacities and competencies of Notified Bodies and to me, one of the key advances is the new responsibilities for Notified Bodies. In short, they have a lot more work to do and need to recruit new expertise and upskill existing team members.
In 2012, there were 87 Notified Bodies. Since then this number has fallen to 58. Now, they need to be designated under the new Regulations and it has become clear that not all will reapply – and, for those that do, not all applications will be successful.
In terms of demand for their services, the only way is up. Additional and stringent requirements mean an enhanced role for Notified Bodies. Some products that were not subject to conformity assessment and post-market surveillance before, notably a large volume of IVDs, will now require much closer scrutiny.
There are too few appropriately-staffed Notified Bodies to absorb the workload that is about to land on their desks. For many manufacturers, this will make it challenging to obtain certification under the Regulations. This uncertainty is bad for business, especially smaller players. For patients and health services, it risks delaying or discontinuing access to medical technology products.
To address a clear long-term need for new skills, the Lübeck University of Applied Sciences is offering an online MSc in Regulatory Affairs for professionals in the medtech field. While this may not solve the short-term challenges, it can help strengthen the system in the years ahead.
To me, this is a really exciting opportunity to bring expertise in regulatory affairs and biomedtech sciences to those who need it. Our faculty has been offering a modular online training course since 2013. Our masters study programme, launched last year, brings even greater depth and academic rigour for those keen to develop expertise in this important field.
The course is 100% online, apart from a two-day kick-off meeting and a small number of exams which are done in person for each semester. The vast majority of the work is done through a Moodle learning room, web conferences, an in online discussions.
I must admit, I initially had some doubts about how well an online course would work as it was a relatively new departure for me. However, it has surpassed even my most optimistic expectations. The students really like it and I have found it a pleasure to be involved with.
Our course is designed to cover the basics of regulatory affairs (conformity assessment, classification and so on); clinical affairs and clinical evaluation (including performance evaluation of IVDs), and essential elements of biomedical engineering. We also offer a module on international regulatory affairs focusing on leading markets (US and Japan) and rapidly emerging markets such as China.
One of the questions I am often asked about the MSc is why we went for an academic masters’ programme rather than a simple training module. My answer is that the market is crying out for a more rigorous course that leads to an academic qualification. And by encouraging students to undertake projects and thesis, we will also foster greater research and insights into the regulatory affairs environment in Europe.