UK notified body qualifies for certain EC inspections:
This article was originally published in Clinica
SGS Yarsley ICS has joined the British Standards Institute (BSI) to become the second notified body in the UK qualified to carry out Annex III EC examinations and Annex IV EC verifications of medical devices. Annex III concerns batch testing and Annex IV covers sample product testing to meet the requirements of the Medical Devices Directive. The Durham-based body is also notified under Annex II (quality systems certifications) and Annexes V and VI (same product quality assurance). It was granted this extension of its certification scope together with SGS Bio Pharma in Wavre, Belgium. SGS Yarsley now plans to become a notified body for the IVD Directive.
You may also be interested in...
According to the plaintiff, Unilever’s Pond’s Rejuveness Anti-Wrinkle Cream is defective insofar as tested product has been found to contain unlabeled mercury, constituting negligence that has resulted in user injuries. The plaintiff seeks certification of a transnational class and compensatory and punitive damages, among other relief.
HBW Product Launches: New Chapter Collagen, Alkamind Acid-Kicking, GNC China, Tetra Bio Canada, More
GNC, Harbin launch supplements in China following regulatory approval; Bee Gone expands with allergy swabs; Bed, Bath & Beyond expands distribution of CBDMedic personal care products promoted by Rob Gronkowski; Tetra Bio has Canadian OK For hemorrhoid and pain relief OTCs, US and European pending; Agrozen offers Urban Daze CBD products; New Chapter portfolio expansion also includes fermented vitamins, elderberry supplements and magnesium; and Alkamind’s Acid-Kicking Coffee Alkalizer creamers help neutralize acid from coffee.
In joint complaint, the FTC and New York Attorney General allege scheme to block generic Daraprim and maintain exorbitant list price; they cite hundreds of emails the incarcerated Shkreli has exchanged with co-defendant in last six months.