Albert Cefalo
Instructor Albert Cefalo
Product Id 600061
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

MDD Essential Requirements: An Overview


Any medical device manufacturer seeking market clearance in the European Community must meet and follow the Medical Device Directive or MDD. Since its original release in1993 there have been several updates to this directive, the most significant of whic

This Directive not only affected the Medical Device Directive but also amended Council Directive 90/385/EEC relating to active implantable medical devices, and Directive 98/8/EC concerning the placing of biocidal products on the market.  As part of this directive, additions were made to the Annex I of the MDD which is the Essential Requirements. The implementation date of the new Directive is March 2010 and device manufacturers marketing devices into the EU will need to comply on that date. Planning for this implementation should be happening now. One major addition to the Essential Requirements is the inclusion of Clinical Data.  Another addition is "For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification". This webinar will review the changes to MDD Annex I and the Essential Requirements along with an in depth look at all of the Essential Requirements. Using examples from experience in the submission of technical files which included Essential Requirements, the speaker will provide you with information which can be used for your devices. As an integral part of your technical files it is important that you can demonstrate compliance to the Essential Requirements. This webinar will assist in your achievement of this requirement.

Areas Covered in the seminar:

  • Overview of Annex I of 93/42/EEC (MDD) the Essential Requirements and the changes made in 2007
    • Concentration on The Essential Requirements Including:
      • Changes made with 2007/47/EC
      • New Requirement for Clinical data
      • New Requirements for Software
      • Making your Essential Requirements Auditable
      • Relationship to the Technical File Requirement of the MDD

Who Will Benefit:

  • Design Engineers
  • Quality Assurance Personnel
  • Program Managers
  • Manufacturing Engineers
  • Regulatory Personnel
  • Engineering Managers

Speaker Profile
Albert Cefalo, Regulatory Affairs Specialist, Analogic Corporation. Chuck has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at Analogic he has involved in all activities related to Quality Assurance and Regulatory Affairs such as Creation and maintenance of SOPs, FDA, Health Canada and CCC submissions as well as served as Director of quality for several of Analogic's Business Units. Chuck also conducts in-house training on a variety of subjects. Chuck is the Regulatory Affairs representative on all of the Analogic Project Teams and provides an oversight of the Risk Management process.

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