"Why choose BSI for certifying your devices with ancillary medicinal substances?
BSI is very proud of our unrivalled history in certifying medical devices incorporating medicinal substances. With our extensive knowledge and experience in this area, BSI will provide you with timely, responsive and informed support at every stage of the certification process."
Note that growth factors are given as examples of ancillary medicinal substance and woundcare preparations/creams as examples of devices.
Also,
"During the certification process for devices with an ancillary medicinal substance, the Notified Body must review device aspects and seek the opinion of a European Competent Authority in relation to the ancillary medicinal substance incorporated in the device.
Prior to seeking the opinion of the Competent Authority, BSI must verify the usefulness of the medicinal substance incorporated in the device.
The Competent Authority will provide the Notified Body with a scientific opinion on the quality and safety of the substance taking in to account the clinical benefit/risk profile of the incorporation of the medicinal substance into the device.
The review of the medicinal substance by the Competent Authority may take up to 210 days and usually runs in parallel with the review of the device by the Notified Body."
But BSI didn't seek a review from the Competent Authority until after the interminable debate about device classification.
Does the website reflect a change in how BSI approach this issue post-TIS debacle? Maybe its been a learning experience for all.
TIS Price at posting:
11.0¢ Sentiment: None Disclosure: Held
