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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 […]

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 […]

This blog is part of the Early Diagnosis campaign #BeFirst Early diagnosis and care can prevent illness from developing and slow disease progression. Lab tests, genetic tests, tests for chronic diseases and modern lab diagnostics can help facilitate earlier intervention and improves outcomes for patients and are increasingly valuable in informing treatment choice.  Read the other […]

Empowering the citizen when it comes to healthcare involves several elements, writes European Alliance for Personalised Medicine executive director Denis Horgan. It can be education regarding what is actually out there in modern medicine (not least full-genome sequencing), leading to more up-to-date knowledge on the part of the patient and the healthcare professionals (HCPs), it […]

One year has now passed since the ‘new’ EU IVD and medical devices regulations entered into force. Since Day 1, the medical technology industry has been working at full capacity to achieve and maintain maximum possible readiness.  While I’d love to claim the same for all other essential elements of the new regulatory system, progress […]

We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike. Last week, at the Association of the […]

At long last, the date has arrived.  Organisations who aspire to be Notified Bodies under the European IVD and medical devices regulations can submit their applications as of yesterday, 26 November 2017.  In order for the new regulatory system to function as intended, it is essential that these assessment bodies be up-and-running as early as […]

As Germany goes to the polls, the VDGH, which represents in vitro diagnostics companies in Germany, has published a new policy paper on the future of healthcare. VDGH Managing Director Martin Walger tells Gary Finnegan why this is a crucial moment for health policy The paper was released just ahead of federal elections in Germany […]

According to the preliminary results of a study* aimed at the Finnish medical device industry, regulatory compliance pops up as the second biggest challenge burdening the industry. This, according to the study, comes in the wake of challenges for establishing effective international distributor channels. To me, this only verifies what I have experienced working in […]