Neither manufacturers nor notified bodies are to blame for delays in implementing the EU Regulations on medical devices and in vitro diagnostics. It is down to bad project management; there are ways forward through dialogue and compromise, but time is tight, Bassil Akra tells Medtech Insight.
It is wrong to blame manufacturers and notified bodies for the slow rate of compliance with the EU Medical Device and IVD Regulations (MDR and IVDR).
The responsibility for the delays lies in many areas, most of which are beyond manufacturers’ control, Bassil Akra, CEO of consultancy firm Akra
FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.
Despite regional unrest, it is business as usual for medtech innovators and investors in Israel as evidenced by continued high-value M&A of locally developed technologies. Irit Yaniv, co-chair of the medtech session at the upcoming BioMed Israel 2025, explained the unique dynamics of Israeli medtech innovation.
Communication with patients has become a particularly crucial factor for investors, payers, and other healthcare decision-makers in a hostile market environment.
