[FEATURED] Substantial Drop In Certificates Withdrawn By EU Notified Bodies: Why Now?
Data from TEAM-NB, the EU notified body association, shows a big drop in withdrawn certificates from device firms. Does this signal an improvement in the quality of manufacturers’ submissions to […]
[FEATURED] Does EU Regulation Of 3D-Printed Implants Expose Gap In MDR Regime?
“Given that 3D printing is used for making device implants, many would expect tight regulation. But the EU Medical Device Regulation does not specifically regulate it, and there may be […]
[FEATURED] EU Regulatory Reads, 2017: Are We Heading Toward A 2018 Crisis?
“Since the EU’s new Medical Device and IVD Regulations took effect in May 2017, progress toward implementation has been painfully slow. So, what is needed in 2018 to ensure the […]
