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.
Article 5 of the IVDD is all about the presumption of IVD medical devices complying with their essential requirements and the only sure-fire way to ensure compliance is achieved is through the application of harmonized standards and common technical specifications.
This edition has two important takeaways: one, without a CE mark, the device cannot enter into commerce in the EEC; and two, the language requirement will continue to be a big challenge for device manufacturers as more countries opt to have labeling and IFUs in their native tongues.
The path toward conforming to essential requirements begins with a robust design and development process that ultimately results in an IVD medical device that is safe and effective in its intended use.