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.
Understanding the significance of Article 9 and correctly classifying a device will drive the entire qualification process by identifying the appropriate Annexes needed to support the testing and application of IVD medical devices.
IVD medical device manufacturers that fail to act quickly in regards to addressing issues associated with bad devices, will be on the receiving end of the splenetic tone coming from each of the Member States from their respective Competent Authorities.
IVD device manufacturers should always be aware of obscure and not so obscure changes made to the IVDD and Directives as a whole, especially with more changes to the IVDD being planned.