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.
The device industry is far from being utopic, so manufacturers need to be ready to quickly respond to and act with integrity when the Competent Authorities come knocking on the door with concerns about device safety and efficacy.
The regulatory authorities in the EU are getting much better at managing the flow of information as it pertains to device manufacturers, device registration, certificates, and vigilance reporting. Prior to May 2011, use of the EUDAMED was strictly voluntary; now, however, it is mandatory and the Competent Authorities, from each of the Member States, are required to input data into the databank.
If an IVDD manufacturer designs develops, and manufactures IVDDs that are safe and effective, then incidents of vigilance reporting will be few and far between.
Article 10 (Registration of Manufacturers and Devices) delineates the notification requirements in regards to the Competent Authorities located in each of the Member States; and the need to have a European Authorized Representative, with a valid European address, if a manufacturer does not have a registered place of business in the EU.
