Time up for EU states on breast implants directive:
This article was originally published in Clinica
Executive Summary
This week's issue of Clinica (No 1068) coincides with the August 1 deadline by which all EU member states should have transposed into their national laws the EU Breast Implants Directive in readiness for the regulations to take effect on September 1. The Directive 2003/12/EC imposes stricter manufacturing requirements on breast implants by upgrading them from class IIb (medium-to-high) risk to class III (high risk), ensuring that the notified body will have to review the manufacturer's design dossiers. Directive 2003/12/EC on the reclassification of breast implants was adopted on February 3 and published in the Official Journal of the European Union on February 4. Breast implants that are placed on the market before September 1 2003 will need to be assessed against the stricter requirements by March 1 2004.
You may also be interested in...
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.