IVDD – Article 2
Article 2 of the IVDD establishes the salient requirements with which IVD devices need to comply to gain entry into the EU. Remember, there is no such thing as minimum compliance, or maximum compliance; it’s just compliance.
Article 2 of the IVDD establishes the salient requirements with which IVD devices need to comply to gain entry into the EU. Remember, there is no such thing as minimum compliance, or maximum compliance; it’s just compliance.
There are four fundamental differences associated with Article 1 of the IVDD versus the MDD. It is incumbent upon device manufacturers to comprehend these fundamental differences along with definitions specific to the IVDD to support the successful entry of in-vitro devices into the European market.
True sustainability isn’t about compromise; it is about creating innovative solutions that are not only good for the world, but good for business.
This series of articles will be premised on the IVDD.The primary takeaway from this week’s edition is that there are significant similarities between the MDD and the IVDD. However, there are also several differences that make the IVDD appear quirky. With revisions to the IVDD looming on the horizon, ongoing compliance with this Directive will continue to be a challenge.
Annex XII (CE Marking of Conformity) of the Medical Device Directive is all about the Mark, the whole Mark, and nothing but the Mark. The regulatory gods in the EU like their CE marking of conformity just as the mark is depicted in Annex XII. Dr. D’s best advice is to abide by the Annex and leave perfection alone.
Medical device manufacturers are increasingly aware of the need to conduct in-depth user research in the field as part of the product requirements process. Little information exists on what to expect when conducting user research in the OR. Although every hospital is different, here is some practical advice from our recent experience.
The takeaway from this edition of DG is extremely simple. Device manufacturers wishing to enter into the European device market must have a notified body. And under Annex XI of the Medical Device Directive, device manufacturers can take some comfort in knowing that notified bodies are also held to a high standard.
The takeaway from this week’s edition on MDD Annex X (Clinical Evaluation) is simple: the expectations of the Competent Authorities are that medical devices should always be safe and effective while conformity to essential requirements is achieved.
Instead of who should begin the conceptualization of new products—engineers or industrial designers, the question probably should be what attributes are more valuable in early product development—words, numbers, drawings or CAD…
The take away from this week pertains to the accuracy of the declaration: device manufacturers need to ensure all of the information depicted within the declaration is factual and accurate, including those relating to rules and classifications.