product liability

Policymakers spent years on agreeing on one of the most modern medtech rules in the world – this should not be undermined by revisions to horizontal legislation. As Brussels powers down for a short summer lull, I find myself in a reflective mode. The pandemic has transformed our lives – suffice to say that we have all worked through our share of challenges. Our industry has worked hard to implement major new legislation while coping with other pressures. The Medical Devices Regulation (MDR) entered into full legal application in May, and we continue to work tirelessly to prepare for the application deadline of the In Vitro Diagnostic Medical Devices Regulation (IVDR) in May 2022. Those of us who lived through the drafting and redrafting of those heavyweight legal texts can attest to the complexity of the process. The regulations will support a level playing field amongst approval bodies and the scope has been tightened up and includes more product groups. There will also be more oversight from authorities, and transparency on products will increase significantly. All of that will hopefully significantly strengthen the trust in the CE marking system, medical technologies and the new legislative framework alike. Nevertheless, there are already signs that the increased complexity for getting to the market – including new post-market responsibilities – may be turning some off investing in innovation or launching new technologies on the European market. Policymakers, industry and other stakeholders have made considerable efforts to ensure ex ante that the MDR and IVDR protect patients and promote access to innovative products and solutions. Medtech innovation, it should be said, is in the interest of patients and consumers. The philosophy embedded in the MDR and IVDR reflects this need. Today, I must confess to a sense of unease when I hear talk of...