Articles

Results 1 to 5 of 62


MDR/IVDR update - Sympathy, but no relief

United Kingdom - June 14 2022 At the end of last week, the Competent Authorities for Medical Devices (CAMD) released a statement following their 50th Plenary meeting.[1] The…

Harry Woodcock

Spotlight on IVDR - The European Union’s new In Vitro Diagnostic Medical Device Regulation is here

United Kingdom - May 27 2022 The European Union’s new In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) is here, a revolutionary piece of legislation which (for…

Jamie Hatzel, Harry Woodcock

The start of Golden Age? The rise of private equity

United Kingdom - May 24 2022 What was notable about the Bain Capital deal was not simply the sheer amount of money raised, sizeable though it was, but who had raised it. After…

David Horner

Spotlight on IVDR - Will the European Commission blink?

European Union, United Kingdom - May 23 2022 The rollout of the In Vitro Diagnostic Medical Device Regulation (IVDR) is imminent. As it stands, there is not enough Noti ed Body capacity, and…

Jamie Hatzel, Harry Woodcock

Spotlight on IVDR — Circumventing the Notified Body bottleneck

European Union, United Kingdom - May 17 2022 Together, the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) represent the greatest regulatory…

Jamie Hatzel, Harry Woodcock