This weeks guidance delineates the steps that a device manufacturer must perform in the pursuit of making application to their notified body. The end result of a successful application process will be the authorization to affix the CE mark of registration onto product packaging and the entry of product into commerce within the EU.
Annex II of the IVDD is critical as it ultimately drives the path for establishing and complying with essential requirements, and hopefully, the eventual approval from your notified body. And significant changes to Annex II are coming.
From Dr. D’s standpoint, similar to 93/42/EEC (the MDD), the Annexes are where the proverbial rubber actually meets the road for device manufacturers.
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.