Less than two months after the MDR applied in the EU, GMED’s Tarik Krim explains how his notified body navigated the early phase of the transition from auditing the directives to the regulation, and how the change has impacted its clients and demand for services.
The run up to the full implementation of the EU Medical Device Regulation was a period of intense activity and change for notified bodies, which, among other things, had to seek designation against the new rules and adjust from testing against the medical device directives to the much stricter requirements of the MDR.
It has been a challenging time, not least because certain aspects of the new regulation, such as standards and the...
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.
European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.
