Apr 1, 2007
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.
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.
The European Commission has officially adopted a new Directive that is of critical importance to most medical device companies selling and/or conducting clinical trials in Europe.
A new revision to BS EN 1041:2008 has been released. This Standard specifies the information that must be supplied with each medical device sold in Europe.
The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices. EU regulators have launched a public consultation in conjunction with a process review of the Transparency Directive (89/105/EEC) intended to revise pharmaceutical pricing rules, which have not been updated since 1989.
Directive 2007/47/EC becomes effective March 21, 2010 and will require Notified Bodies to review a sample of Technical Files for Class IIa and Class IIb devices. The most frequent question from companies with numerous devices has been: What is an appropriate sample?