It really does not get any easier than these two articles when discussing the virtues and implications associated with compliance to this Directive. Enjoy!
This week’s Article 22 delineates the salient requirement that Member States must comply with this Directive. Compliance to Directives is not optional for the manufacturers of IVDDs and the same holds true for all 27 Member States. Isn’t life grand?
Although Article 21 of the IVDD does not directly influence the Directive, “changes are coming,” so please stay tuned.
Remember, “cooperation” is the key term in understanding the fundamental concept of Article 20.
This week’s guidance is all about ‘keeping secrets’ and has three takeaways: having a signed contract and NDA in place; properly labeling all confidential information; and knowing that all information cannot be categorized as confidential.
Article 18 does provide for an open channel, ensuring lines of communication exist between the 27-Member States, their Competent Authorities, the offending device manufacturer, and the device manufacturer’s European Authorized Representative.
For this edition of DG, there is just one takeaway: there is never a good reason to have product in the European device market with a wrongly-affixed CE Mark.
The regulatory gods in the EU like their CE Mark as is, so there is no need for improvement. In fact, the notified bodies are mostly in agreement (a rare event indeed) that there needs to be consistency in regards to CE mark construction and visibility.
The takeaway from this week’s edition is pretty simple; in reality, it comes down to two words: oversight and compliance.
There are two takeaways from this week: One, Member States retain the right to request revisions to the list of devices delineated under Annex II of the IVDD, and pursue device conformity via the derogation from provisions established by Article 9; and two, the Commission will not blindly make a decision and will review available device information, including vigilance procedures, prior to rendering an opinion.