MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System was updated in January 2013.  The revised guidance is applicable as of July 2013.   The revision contains clarifications rather than significant changes.

Download the MEDDEV 2.12/1 revision 8 Guidelines on a Medical Device Vigilance System effective July 2013.  An unofficial Comparison of MEDDEV 2.12/1 from revision 7 to revision 8 can be downloaded, as well. 

Changes include:

• Clarification that, in addition to IVD’s, indirect harm can be from:
  • diagnostic devices,
  • consequence of the treatment of cells (e.g. gametes and embryos in the case of IVF/ART devices) or organs outside of the human body that will later be transferred to a patient, or
  • software qualified as medical devices (e.g., incorrect information generated by software).
• Reinforcement that, when there is doubt, a report should be submitted.
• Clarification that, regardless of how a lack of performance to labeled specifications is identified (field report, in-house testing, etc.), if the issue might lead to or might have led to death or serious deterioration in the state of health associated with the use of the device and the issue impacts a product that has already been placed on the market then a field safety correct action (FSCA) must be initiated.
• Adds “absence of treatment” as an indirect harm that must be considered.
• Indicates that a National Competent Authority should consult the manufacturer or the manufacturer’s European Representative before forwarding a National Competent Authority Report (NCAR) to fellow National Competent Authorities.
• Updates to reporting formats from the MEDDEV website are below in the formats that they provide them in:

Manufacturer Incident Report(971 KB) 
How to use the MIR(13 KB) 
Field Safety Corrective Action(2 MB) 
Trend Report(151 KB) 
Periodic Summary Report(192 KB) 
MIR and FSCA xml files(2 MB)  

Actions to consider:

• Review your MEDDEV procedure(s) to ensure that:
  • Any source of indirect harm will be considered and, if such could result in harm, will result in submission of an incident report.
  • Actions taken to reduce risk of death or serious deterioration in the state of health associated with the use of a device that is already placed on the market will be reported through a Field Safety Corrective Action Report.
  • “Absence of treatment” is an indirect harm that will be considered when making a reporting decision.
  • Where there is doubt, a report will be submitted.
  • Referenced forms reflect the current versions and requirements for completion.
• Review the contract with your European Representative to ensure that it is clear on how the company expects the EU Rep to respond to a request for comment on a NCAR.

Many thanks to Helene Spencer to highlighting the new revision (and for indicating that, with a little work, it is possible to create an unofficial redline).

If you need assistance with this or other issues, please contact us at Leo@EisnerSafety.com.  As a reminder, you can access a full list of MEDDEV’s from the MEDDEV guidance website .

This issue we are going to focus on primarily on the MDD Amendment 2007/47/EC as the deadline to comply is very soon.  You must comply with the MDD Amendment 2007/47/EC as of March 21, 2010.  There is no transition period for the amendment to the MDD.  First, we are presenting an audio conference titled “Are You Ready for the MDD Amendment Directive 2007/47/EC” which will be on January 25^th.  Please come and join in the audio conference.  See below for a special discount code that only Eisner Safety Consultants is able to provide to you.  Next we provide you with updated MEDDEV Guidance documents that have been updated to align with the Amendment to the MDD.  In addition to the above items to help you out you can also purchase our MDD Amendment Toolkit, which is only $249.00.

We will occasionally provide you with an Associate Profile so you can get to know some of our varied staff and some of their experience.  This edition we feature our newest Associate, Alf Dolan.

If you have any questions regarding any of the subjects of this newsletter please feel free to contact us.  We hope you enjoy our fourth newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

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