Eisner Safety Consultants

The old version of the MDD expires
March 20, 2010 – Are you ready?

Adapted from an article by our associate Christine Ruther

The changes (Amendment 2007/47/EC) to the current EC Medical Device Directive (MDD) 93/42/EEC become mandatory on March 21, 2010.  By March 21, 2010 all your distributed products must comply with the amended version of the MDD.  The Amendment also updates the Active Implantable Medical Device Directive and so the same date applies for that as well.  There is no grandfathering of products that will be distributed into Europe after March 20, 2010. Your installed base is not affected.

Here is a partial list of items of the changes to consider to help you comply with the revision to the MDD.  To make this process easier for you we have developed a Gap Analysis & Update package for the MDD Amendment that will help you thru this process too.

• Develop a plan for your company to transition to the amended MDD.  You may need to make a hard decision to discontinue distribution of older or lower volume products rather than spend the time and resources to update the applicable technical files and design dossiers.
• Review Annex IX (Classification) definitions and rules, as there are modifications in this Annex, which can impact the classification of your product and the conformity assessment route.  Some of the changes include:
  • Standalone software is considered to be an active medical device.
  • Central circulatory system definition has been corrected to include all parts of the aorta.
  • If device intended used is for disinfecting invasive device now Class IIb.
• Check if the conformity assessment route is still appropriate.  If not your current notified body certificates may need to be updated.
• Your Technical Files and Design Dossiers will need to be updated to show compliance to the updated requirements of the directive.  Some of the changed requirements of the Directive include:
  • Clinical data (Annex X) is required for all products (independent of classification) and from every manufacturer.
  • Per Article 3 of the MDD the Machinery Directive 2006/42/EC requirements need to be considered but you don’t need to CE mark to the Machinery Directive.  For active medical devices you can use the expanded mechanical requirements of EN 60601-1, 3^rd ed. to help you show compliance to the applicable Machinery Directive requirements.
  • There are many changes to the essential requirements (Annex I).  Below is a small portion of the changes.
    • Reduce the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used shall be.  There are two harmonized Usability standards that you may want to reference for this task.  They are EN 62366 or EN 60601-1-6.
    • Phthalates are discouraged and if products do contain Phthalates they must be labeled.
    • Software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.  Reference a harmonized standard such as EN 62304.
  • Record retention for implanted devices has been extended to 15 years.
  • The amendment of the MDD means each country will have to / or has transposed the MDD into its’ national law.  Therefore, there may be additional changes, per country, that was enacted that would apply to your product lines.   Many countries are now requiring registration of all class IIa, IIb and III devices.  The national registration processes can require the manufacturer to provide a copy of the device labeling.  The manufacturer should provide the labeling in the native language in line with the transposed national law.