PharmaLex applies expert knowledge of EU medical device regulation and achieves a positive opinion from the MHRA on a Class III medical device, despite a flawed study design.

  • A US-based company developed a class III medical device with an ancillary medicinal product (according to Rule 13, Annex IX of the Medical Device Directive 93/42/EEC).  The data were positive in a multi-center, randomised, comparative clinical trial but a prospective protocol-defined primary endpoint was flawed and unfortunately this led to early termination of the study.  With the risk of needing to repeat the trial, the company required a partner with specialist knowledge of EU medical device regulations and strong Notified Body experience to avoid a significant delay and costly consequence.