UK notified body qualifies for certain EC inspections:
This article was originally published in Clinica
Executive Summary
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.