Last week, Germany’s Federal Ministry of Health has adjusted the rules governing Digital Health Applications (DiGA) once more. Key changes include new reporting obligations that require manufacturers to measure and document the success of their digital health apps. This reform adds notable operational pressure, while the reported outcomes will directly
Continue Reading Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More WorkGerman Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects
Germany has kicked off a new Pharma and MedTech Dialogue that aims to develop new policies and regulatory reform proposals to re‑establish Germany as a competitive, innovation‑friendly location for life sciences R&D and manufacturing. The outcome of this dialogue shall be the basis for a new German Pharma and MedTech
Continue Reading German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects
European Commission Announces (Long Awaited) Proposal to Simplify EU Medical Device Regulations
The European Commission announced today (16 December) its plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices (“IVDs”). Many industry stakeholders have criticized the current EU device rules as being slow, costly, unpredictable, and unnecessarily complex. Under the proposed revisions, the Commission
Continue Reading European Commission Announces (Long Awaited) Proposal to Simplify EU Medical Device RegulationsHow do the recent changes to the MDR and IVDR impact you and your medical devices? — Top 10 Questions
To avoid a real and imminent risk of shortages of devices on the EU market, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU) 2017/745 (the “MDR”) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the “IVDR”). The Commission has published a Q&A on the practical aspects of the latest changes (the “Q&A”). We set out the top 10 questions to think about when assessing how the changes to the MDR and IVDR may impact you and your medical devices.
Continue Reading How do the recent changes to the MDR and IVDR impact you and your medical devices? — Top 10 Questions