124 results
Posted on 24.04.2019
Regulatory affairs: One way of addressing the skill shortage Notified Bodies are facing
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 […]
Posted on 01.02.2019
Putting Health and Innovation at the heart of a European Social Contract
Given that the number of Europeans aged over 65 will double in the next 50 years, and the number of over 80 year olds will almost triple, it follows that keeping this age group in good health is a particular priority. However, European healthcare systems are at a tipping point, driven by the increasing burden […]
Posted on 25.01.2019
Leprosy: the forgotten disease
Leprosy is the oldest known disease to humanity, but it is also one of the least understood and accepted. Contrary to popular belief, it is also a disease that is very much with us. To the public at large, leprosy is a largely forgotten disease with many believing it was eliminated or consigned to the […]
Posted on 02.10.2018
IVDR: The designation issue during the transitional period
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 […]
Posted on 14.09.2018
What does Brexit mean for Notified Bodies?
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 […]
Posted on 12.09.2018
New EU regulations: what’s next for Notified Bodies?
It is now circa ten months since any well-prepared Notified Bodies (NB) wishing to undertake conformity assessment under MDR (EU) 2017/745 and IVDR (EU) 2017/746 were able to submit formal applications. The date of application of the MDR and IVDR, 27th May 2020, is currently 20 months away. I would like to publicly acknowledge the […]
Posted on 06.09.2018
Patients & Medical technologies: why we must deepen our dialogue
As healthcare advocates, we know that dialogue between patients and the medical technology industry can deepen understanding between those who develop new healthcare solutions and those who use them. That is why our organisations, the European Patients’ Forum (EPF) and MedTech Europe, devised the Patient-Medtech Dialogue as a forum for regular interaction on topics of […]
Posted on 21.06.2018
Distributors play key role in compliance
This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, How to create and maintain an ethical culture, Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress […]
Posted on 11.06.2018
New Medical Device Regulation – an obstacle to progress
On May 25th, 2017, a new era began. The date marks the beginning of the Medical Device Regulation, the MDR in short. It provides a new framework for the certification of medical devices in Europe and is supposed to increase the transparency of the approval and application of medical devices, as well as to improve […]