Regulatory News – Unannounced visits

Two years ago very few people had heard of, never mind experienced the so-called unannounced visit.

Following the PIP breast implant scandal, the EU Commission introduced measures aimed at improving the safety of medical devices, one of which, introduced in 2014 was the requirement for Notified Bodies to complete unannounced visits to device manufacturers.

Tissuemed is pleased to report that following one such visit (with no prior knowledge), our Notified Body has provided positive feedback and we have been given a ‘clean bill of health’.

Dr David Mandley for Tissuemed commented, “I am extremely proud of the Quality Management System here at Tissuemed,. It’s robust and effective, and it supports various aspects of the business. I’m pleased we’ve passed with flying colours – it’s a credit to all colleagues who were involved during this visit.”