Notified bodies will need to clear a few more hurdles when recommending a CE Mark for a drug-device combination in the UK.
The UK’s Medicines and Healthcare products Regulatory Agency issued updated guidance for notified bodies to evaluate drug-device combination products. The new guidance refers to medical devices incorporating an ancillary medicinal substance, such as drug-eluting stents, catheters coated with heparin or antibiotics and wound dressings with antibacterial agents.
Information addressing the safety, quality and usefulness of the medicinal substance should be submitted to the notified body and then forwarded to the MHRA. The notified body must first verify the “usefulness” of the medicinal substance as part of the medical device, taking into account the intended purpose of the device.