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.
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.
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.
