The French National Agency for Medicines and Health Products Safety has updated its Guidance and templates for consultation for medical devices with ancillary medicinal substances.
Scientific opinion must be requested for any new medical device or device-drug combination product, even if the medical device taken in isolation is already CE marked or if the medicinal substance already has a marketing authorization.
Meditrial team of medical, regulatory and technical experts will assist you to efficiently bring innovative medical devices and combination products to market. Please feel free to contact us for advice and support.
“When a medical device incorporates a medicinal substance as an accessory, the notified body (responsible for issuing the EU certificate of conformity leading to the CE marking of the device) must call on a competent authority in the field of medicinal products for the evaluation of the quality and safety of the active substance, as well as the benefit / risk profile associated with its incorporation into the device.
The scientific opinion delivered by the competent authority or by the European Medicines Agency will take into account the data relating to the usefulness of the incorporation of the substance assessed by the notified body.
Note, this procedure only applies to medical devices when the activity of the drug substance is accessory, that is to say when the substance is not responsible for the main activity but acts on the human body by an action accessory to that medical device.”
The updated forms (listed below) can be found on the ANSM website in English and French language version:
- Guide for notified bodies and manufacturers on the procedure to be followed and the documentation necessary to consult the ANSM (07/20/2021)
- Application form for QS consultation (20/07/2021)
- Notified body decision (07/20/2021)
For more details, please see the official communication from the ANSM (in French language).
Contact Meditrial for immediate assistance in Europe or the US.
I needs to spend some time studying more or figuring out more.
Thank you for magnificent information I used to be on the lookout for this info for my mission.
An intriguing discussion is definitely worth comment.
I believe that you should publish more on this subject matter, it may not
be a taboo subject but usually folks don’t talk about such
issues. To the next! Best wishes!!
Sorry I know it sounds strange but I am wondering if any
other poster knows what theme this site is using because I
really love it thank you
I believe this is one of the most important pieces of information for me.
And I am glad to read your article. But wanna remark on some normal issues, The site taste is wonderful, the articles are excellent.
Just desire to say your article is as astounding. The clearness in your post is just nice and i could assume you are an expert on this subject.
Fine with your permission allow me to grab your RSS feed to keep up to date with forthcoming post. Thanks a million and please carry on the rewarding work.
I actually like what you have got here, really like what you’re saying and the way during which you assert it. You are making it enjoyable and you still take care of to keep it smart. I can not wait to learn much more from you. That is really a great website.
Hi there i am kavin, its my first occasion to commenting anywhere, when i read this post i thought i could also create comment due to
this brilliant paragraph.
Thanks for a marvelous posting! I really enjoyed reading it, you can be a great author.
I will make sure to bookmark your blog and will eventually come back in the foreseeable future.
I want to encourage you to continue your great posts, have a
nice holiday weekend!