Profile

I agree with Dan based on the wording in Article 120(3) stating that it is with a valid MDD / AIMD certificate that a device can continue to be placed on the market "provided that it continues to comply with either of those directives​. . . "  I believe this includes the labeling requirements of those ...

Check out Grand Avenue. It is a very cost effective solution for small companies and easy to use.  The company is good to work with as well.  I do not know if they have implemented clinical data management into it though or if they have plans to. ------------------------------ Amy McKinney RAC Sr ...

It depends on your Notified Body really.  BSI is no longer reviewing products under MDD and TUV announced that their cutoff for reviewing significant changes under MDD is in November.  I do not know about other Notified Bodies or if any are still accepting new applications or not.  I think timing and ...

Per paragraphs 1 and 6, it is only applicable to manufacturers and authorized representatives. ------------------------------ Amy McKinney RAC Sr Manager, Regulatory Affairs, Interventional Oncology Fulshear TX United States ------------------------------

I haven't seen any guidances yet about this specifically, but Annex VI, Part C, paragraph 2 states the following: 2.2. The manufacturer shall assign and maintain unique UDIs for its devices. 2.3. Only the manufacturer may place the UDI on the device or its packaging. However, per 3.10: 3.10. ...