Regulation

State of play The aim of Europe’s policies and actions in public health is to improve and protect human health, and to support the modernisation of Europe’s health systems – which the EU sees both as improving the quality of its citizens’ lives, and as a contribution to goals involving growth and jobs. While the […]

20 years ago, I’d have called you foolish if you suggested that the world’s largest taxi company would not own any taxis. I’d have called you ill-advised if you suggested that the world’s largest hotelier would not own any hotels. I’d have thought you unwise if you suggested that the world’s largest book store could […]

With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously!), most manufacturers should now be gearing up to shift from self-certification to notified body oversight as we enter into the third year of the In Vitro Diagnostic Regulation’s transition period. A […]

The new EU regulations on medical devices and in vitro diagnostics (IVDs) share a laudable aim: They seek to modernise the regulatory framework and enhance transparency. The goal, shared by all stakeholders, is to enhance patient safety without harming innovations that improve patient outcomes. However, with these two regulations coming into force by May 2020 […]

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 […]

As I followed the 1,075 km cycling route starting at the Belgium coast and ending in Basel, Switzerland, along the Western Front line of the First World War, I began to consider the plight of soldiers and generals a century ago. For military leaders, it was impossible to have an overview of what was happening […]

The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) was published in May 2017. While the IVDR has a five-year transition period (longer than the three-year transition for the EU Medical Devices Regulation), the procedures to designate Notified Bodies (NBs) under each of these two regulations have started at the same time. NBs are […]

For me, one of the most intriguing health policy questions of our time is how to encourage citizens to embrace healthy lifestyles. Should we tax and punish bad behaviour or empower citizens with the information they need to make their own decisions?   An interesting ‘league table’ caught my eye recently. Entitled the Nanny State […]

With 45% of devices accessing the EU via UK NBs, what would be the impact of a so-called “hard Brexit?” The political landscape is far from clear. However, BSI would concur with the recent MHRA  paper as we fully anticipate remaining part of the EU system for the long term. We also agree that nothing […]