Advice
Regulatory information
Regulatory information
Biopatch was CE marked as a class III device in July 2003.
A search of the Medicines and Healthcare products Regulatory Agency (MHRA) website revealed that no manufacturer field safety notices or medical device alerts have been issued for this technology.
One medical device alert is in place for all medical devices and medicinal products containing chlorhexidine: risk of anaphylactic reaction due to chlorhexidine allergy. The MHRA has received a number of reports of anaphylactic reactions following the use of products containing chlorhexidine.