INTRODUCTION
It is the primary purpose of this document to provide guidance to Manufacturers and Notified Bodies in dealing with the application of Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements adopted by the European Commission on 11 August 2005, hereafter referred to as the Directive3 and taking into account the MEDDEV.
This guidance is intended to provide clarification on approaches to be taken with hip, knee and shoulder joint replacements already assessed as class IIb medical devices under the full quality assurance system of Annex II point 3 to Directive 93/42/EEC, allowing for their complementary assessment under point 4 of Annex II to the Directive4. These products are at various stages in their life cycle from recently developed designs to long-standing products with extensive histories of clinical performance.