Newsletter Summary

• Newsletter Summary
• MDD Amendment Toolkit Now Available
• MDD Amendment Implementation Guide
• EU Vigilance Reporting
• Record Retention Times

Now Available Toolkit to help meet MDD Amendment 2007/47/EC - Only $249.00

The changes to the current EC Medical Device Directive (MDD) 93/42/EEC become mandatory on March 21, 2010. Are you ready for all the changes? All manufacturers of CE marked medical devices must be in compliance by that date. There is no transition date for the amendment 2007/47/EC. Eisner Safety Consultants in conjunction with Roberts Consulting & Engineering is offering a package for device manufacturers to assist them in complying with the changes. Click here to order the package.

The CD package contains the following useful resources to make your job easier in meeting the new changes in a timely and efficient manner. The documents are Word 2003 formatted other than the 2 presentations are in PowerPoint 2003 format:

1. Suggested project plan for transition to the amended MDD.
2. Gap Analysis Checklist as a self-assessment tool. It identifies the changes and provides suggestions of how to address any gaps.
3. Two PowerPoint Training Presentations: A detailed review of the changes - can be used to train staff members that are directly involved in implementing the change. An overview presentation - suitable for training all levels of employees.
4. Updated essential requirements (ER’s) checklist. There are many changes & some reorganization of Annex I ER’s. Use this to revise your technical files or dossiers.
5. Declaration of conformity (DoC) template. There are some changes to the expectation of the contents in the DoC. It is expected new DoC’s will be required for all products to state compliance with the directive as revised by 2007/47/EC. These will need to be in place by March 21, 2010.
6. Clinical data SOP & report template. The revised MDD requires all classes of device have clinical data. The SOP is based on MEDDEV 2.7 and includes templates for a literature search protocol and a clinical data literature report.The revised MDD also requires that clinical data be updated over time. The clinical data SOP addresses this by including requirements for Post Market Clinical Follow Up per MEDDEV 2.12-2.
7. Usability SOP & report template. A major change to the ER’s is that the user of the device must be taken into account. A usability analysis will need to be performed. The SOP provides instructions for this and a template for the analysis process, which needs to start in the concept stage.

This exciting new package is now available for sale on the Eisner Safety Consultants website for $249.00. You can order with a credit card or a Paypal account. Click here to order the package. The product will be sent to you in the mail.

Time is starting to run out. As mentioned above there will not be a transition period and any new medical device must meet the amended requirements of directive 2007/47/EC by March 21, 2010. To help you out the EC published an interpretation document addressing some implementation questions. This document is available for download from our website.

The implementation interpretative document addresses these issues:

• Timing of compliance of medical devices with the updated requirements. This section clearly explains the defined terms of ”placing on the market” and “putting into service”.
• Timing of when you may want to schedule your Notified Body audit especially if you have a new product [remember software now is considered a medical device] or there is a change in classification of the medical device because of the amended requirements.
• Certificates with unlimited and limited validity issued prior to March 21, 2010.
• For Active Implantables with ancillary action medicinal substances the Notified Body must consult the appropriate competent pharmaceuticals’ agency for a new certificate, renewal of an existing certificate, etc.
• How the Machinery Directive and the MDD overlap.

EU Vigilance Reporting

• New terms added include:
  • Field Safety Corrective Action,
  • Field Safety Notice,
  • Use Error,
  • Abnormal Use

• Put in place the following incident reporting timelines;
  • SERIOUS PUBLIC HEALTH THREAT – must be reported IMMEDIATELY, but not later than 2 calendar days after awareness of the threat.
  • DEATH OR SERIOUS DETERIORATION OF STATE OF HEALTH - IMMEDIATELY after the Manufacturer establishes a link between the device and the event, but not later than 10 calendar days after becoming aware of the event.
  • OTHERS: IMMEDIATELY after the Manufacturer establishes a link between the device and the event, but not later than 30 calendar ?days after becoming aware of the event.

Record Retention Times

• ISO 9001:2000 (4.2.4) / ISO 9001:2008 (4.2.4) = The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. No timeframe mandated, however you need to define an appropriate retention time.
• ISO 13485:2003 (4.2.4) = The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than 2 years from the date of product release by the organization, or as specified by relevant regulatory requirements.
• 93/42/EEC MDD Directive Annex II (6.1), Annex V (5.1), Annex VI (5.1), Annex VII (2) = The manufacturer must, for a period ending at least five years after the last product has been manufactured, keep at the disposal of the national authorities...
• 98/79/EC IVD Directive (Article 9, (7)) = The manufacturer must keep the declaration of conformity, the technical documentation referred to in Annexes III to VIII, as well as the decisions, reports, and certificates for a period ending 5 years after the last product has been manufactured.?…
• 90/385/EC (2003) AIMD Directive Annex II (6.1) = “For a period of at least 5 years after the last date of manufacture of the product, the manufacturer or his authorized representative shall keep available for the National Authorities....”

• 93/42/EEC MDD Directive (as amended by 2007/47/EC) Annex II (6.1), Annex V (5.1), Annex VI (5.1), Annex VII (2) = The manufacturer or his authorized representative must, for a period ending at least 5 years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities...”
• 90/385/EC AIMD Directive (as amended by 2007/47/EC) Annex II (6.1) = “For at least 15 years after the last date of manufacture of the product, the manufacturer or his authorized representative shall keep available for the National Authorities...