Classification Challenge

Added: 6th October 2015

A client asked us to assist with classification of a complex novel biomaterial consisting of elements of a medical device, medicinal products and human blood-derived proteins. The company had sought classification advice through both the UK Competent Authority and the European Medicines Agency but needed help with interpretation of the legal definitions and the responses received from the agencies. A number of conflicting recommendations had been received from various sources, leading to understandable confusion on the part of the company. We were able to analyse the situation based on extensive correspondence, and provided a report that explained the regulators' positions, clarified their meaning and intent, and clearly determined the regulatory classification of the product.

"CellData Services did a superb job in helping us to determine the regulatory classification of a complex regenerative medical device. A number of other conflicting opinions had been given which served to confuse the issue. CellData Services worked through the available information to come to a logical and sound conclusion."

Mark Wickham - Principal - Alacrita LLP