Are you still with me on where we are with the EU revision of medical devices and IVD legislation? If you are, you have strong tolerances for fast moving complexity – congratulations! – because so far it has been a wild ride so far with drama, denial and divergence. And it looks like it will […]
Presentations can be downloaded by clicking on the titles:Developments in Clinical trials for medical devices by Joris Bannenberg, Factory CROClinical trial agreements and developments in clinical data transparency by Erik Vollebregt, Axon Lawyers …
After a royal time of suspense, the new Blue Guide has finally arrived. Was it worth the wait and what is new and noteworthy in medical devices? Let’s see. I will take you through this substantial document in a number of blogs, of which this is the first. Some history But first, for those who are […]
We had the first reading vote by the European Parliament on 2 April. Let’s put it in perspective. The previous last important iterations in the legislative process are the EP’s plenary vote on 22 October 2013 and the Council’s discussion of the MDR proposal with respect to reprocessing and market access mechanism. Parliament The Parliament’s plenary […]
A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between the lines of the existing MEDDEV on standalone software (which itself is under revision currently but seems to have been bogged down considerably […]
Wednesday 9 April Clinical Trial DataAxon organizes a seminar addressing recent developments in the clinical trial data requirements in the life sciences sector.Program and invitation …
This spring holiday I took the recently published Study on Corruption in the Healthcare Sector with me as holiday reading and that proved a good choice. The 332 pages long study was commissioned by the European Commission (EC) Directorate-General Home Affairs and involved cooperation between Ecorys, the European Healthcare Fraud & Corruption Network (EHFCN) and individual country […]
Lately I have thought a lot about future-proofing of the new EU regulation proposals for medical devices and IVDs, specifically with respect to the development of 3D printing of individualized (custom) medical devices – which is well on its way with more and more companies joining the fray. With companies like Siemens and GE investing […]
mHealth is one of the big promises worldwide to reduce costs of healthcare and empower patients. The challenges in mHealth are roughly the same in the EU and US: watch Rock Health’s Halle Tecco’s speech in the Stanford Technology Ventures Program identifies systemic challenges facing healthcare in America and shares examples of companies working to address these […]