IVDD Articles 23 and 24
It really does not get any easier than these two articles when discussing the virtues and implications associated with compliance to this Directive. Enjoy!
Tag Archives: IVDD
IVDD Article 22 – Implementation, Transitional Provisions
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?
IVDD Article 21 – Amendment of Directives
Although Article 21 of the IVDD does not directly influence the Directive, “changes are coming,” so please stay tuned.
IVDD Article 20 – Cooperation between Member States
Remember, “cooperation” is the key term in understanding the fundamental concept of Article 20.
IVDD Article 19 – Confidentiality
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.
IVDD Article 18 – Decisions in Respect of Refusal or Restriction
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.
IVDD Article 17 – Wrongly-Affixed CE Marking
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.
IVDD Article 16 – CE Marking
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.
IVDD Article 15 – Notified Bodies
The takeaway from this week’s edition is pretty simple; in reality, it comes down to two words: oversight and compliance.
IVDD Article 14 – The Derogation Clause
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.
