Concern has been mounting about the future of Europe’s regulatory environment for medicines and medical technology, but the growing anxiety isn’t limited to Brussels, London or Munich. Companies from Boston to Tel Aviv to Singapore have a lot riding on Europe. For better or worse, the unease being felt around the world is a mark of both how important the healthcare products sector is to Europe and how important Europe is to the global healthcare products sector.
Europe’s Position as Key Hub for Medicine, Healthcare
Europe comprises about 29% of the global medtech market and 22.2% of the global market for pharmaceuticals. It is easily the second largest market in the world for these vital healthcare products after the United States, and is worth more than €300 billion (nearly $350 billion). Both European and global life sciences companies have invested significantly in European operations with nearly 2,000 pharma companies and 27,000 medtech companies operating in Europe, employing a total of more than 1.4 million people in the region.1
Factor in the indirect employment these industries generate—estimated to be up to 3 million additional jobs created by pharma alone—and investment in Europe-based research and development, and we are talking about a significant portion of the European economy, one of the world’s top three along with the United States and China. Any disruption in the European healthcare product sector reverberates across the continent and around the globe.
As regulatory professionals know well, understanding and comprehensively addressing European regulations is an essential element of any truly global regulatory strategy. Unfortunately, this task has been made much more challenging by the current regulatory environment in Europe, which is experiencing something of a perfect storm of uncertainty.
Time Running Out to Prepare for New Device, IVD Regulations
As we have known for some time now, the EU’s new Medical Device Regulation (MDR) is set to take effect next year, and the In Vitro Diagnostic Regulation (IVDR) will become law in 2022. These two laws will enact sweeping changes to Europe’s regulatory framework for medical technology and remake the way medtech companies develop and market products in the EU. Despite the relatively short time until scheduled implementation, much more preparation is needed, and many questions remain…