Understanding the significance of Article 9 and correctly classifying a device will drive the entire qualification process by identifying the appropriate Annexes needed to support the testing and application of IVD medical devices.
IVD medical device manufacturers that fail to act quickly in regards to addressing issues associated with bad devices, will be on the receiving end of the splenetic tone coming from each of the Member States from their respective Competent Authorities.
IVD device manufacturers should always be aware of obscure and not so obscure changes made to the IVDD and Directives as a whole, especially with more changes to the IVDD being planned.
Article 5 of the IVDD is all about the presumption of IVD medical devices complying with their essential requirements and the only sure-fire way to ensure compliance is achieved is through the application of harmonized standards and common technical specifications.
This edition has two important takeaways: one, without a CE mark, the device cannot enter into commerce in the EEC; and two, the language requirement will continue to be a big challenge for device manufacturers as more countries opt to have labeling and IFUs in their native tongues.
The path toward conforming to essential requirements begins with a robust design and development process that ultimately results in an IVD medical device that is safe and effective in its intended use.
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.
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.
