After a recent statement by the EU health commissioner, it appears that FDASIA's influence may have gone abroad. As the medical device industry gears up and is adapting to the changes that FDASIA brings, it may also have to prepare itself for even more changes heading our way.

At the end of September, the EU announced two proposals, both involving the medical device industry. The first proposal involves general medical devices and active implantables. The second proposal, if passed, would affect in vitro devices. Both proposals call for increased stringency on the assessment of safety and the monitoring of use for medical devices and implants.

The main elements of the proposals include:

  • Broader and more transparent scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified for instance, as regards medical software;
  • Increased supervision of independent assessment bodies by national authorities;
  • More powers and obligations for assessment bodies, to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections and sample testing;
  • Clearer rights and responsibilities for manufacturers, importers and distributors, applying also to diagnostic services and internet sales;
  • Expanded medical device database, providing comprehensive publically accessible information on products available on the EU market;
  • Enhanced traceability of devices throughout the supply chain, with introduction of a Unique Device Identification system;
  • Stricter requirements for clinical evidence;
  • Adaptation of the rules to technological and scientific progress, e.g. to software or nanomaterials used in healthcare;
  • Better coordination between national surveillance authorities; and
  • Alignment to international guidelines.

If these proposals are passed, what would it mean to the medical device industry?

Would some American-based medical device companies decide to remain in the domestic market and opt not to obtain CE Marking?

Are these proposals just now catching up to some of the legislation of the FDA? Or are they in alignment with the recently passed FDASIA?

I welcome your comments, thoughts, and feedback!

-RSpelich ^_^


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