2007年 4月 1日
Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices was issued in August 2005, at the behest of France and the United Kingdom. The Directive altered the classification of those devices from Class IIb to Class III for several reasons: the hip, knee, and shoulder are complex joints, the hip and knee are weight bearing joints, the hip and knee are extremely sophisticated implants, shoulder implants are a more recent technique, and hip, knee, and shoulder replacement surgery is increasing in younger patients. Member states were required to transpose the directive into national law by 1 March 2007 and apply its provisions by 1 September 2007.
Recently, the European Commission's Medical Device Expert Group, MDEG, endorsed a guidance document on this Directive at its December 2006 meeting. The guidance document was issued in January 2007 and is titled Guidance Document on Directive 2005/50/EC on the Reclassification of Hip, Knee, and Shoulder Joint Replacements. The Guidance document delineates the common interpretation by the Member States of Directive 2005/50/EC.
- The hip, knee, and shoulder replacements are defined as an implantable component part of a total joint replacement system intended to provide a function similar to that of either a natural hip joint, natural knee joint, or natural shoulder joint.
- Ancillary components and the devices and accessories needed to perform the implant (e.g. screws, wedges, plates, instruments, and cutting templates) are excluded from the definition.
- Hip, knee, and shoulder total joint replacements (Class IIb) already CE marked following Directive 93/42/EEC relating to the EC type examination (Annex III) coupled with procedure relating to EC verification (Annex IV) or EC declaration of conformity (Annex V, production quality assurance), are not affected as those EC certification schemes are the same for Class IIb and Class III medical devices.
- Hip, knee, and shoulder total implants (Class IIb) already CE marked following Directive 93/42/EEC relating to Full Quality Assurance, Section 3 (Annex II) prior to 1 September 2007, cannot be placed on the market or put into service after 1 September 2009 without additional conformity assessment (point 4 of Annex II leading to an EC design examination certificate).
- Hip, knee, and shoulder total implants (Class IIb) already CE marked following Directive 93/42/EEC relating to the EC type examination (Annex III) coupled with procedure relating to EC declaration of conformity (Annex VI, product quality assurance) prior to 1 September 2007, cannot be placed on the market after 1 September 2010 without additional conformity assessment.
Note that while these transitional time periods exist, the guidance cautions "where a manufacturer is aware that his device no longer meets the requirements of the Directives, i.e. a device that does not meet the requirements of the Directive should no longer be placed on the market and put into service until it is brought back in compliance (e.g. suspend shipments, quarantine stocks if necessary, etc. until the EC design-examination certificate is issued."
We also recommend that you read the Guidance Document on Hip, Knee and Shoulder Replacements published in January 2007.
- Stewart Eisenhart