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 .

The Emergo blog posting says “While the European medical device regulatory system remains largely intact, greater detail has been added, and new mechanisms exist to bolster the weaknesses.” An example, is that in the existing MDD there are only 14 definitions while in the proposed Regulation there are now 50 definitions.  As you can see from this example the intent is to clarify the regulation so it is better understood. The Emergo blog post summarizes the high level primary changes while the Emergo White Paper goes into a much deeper analysis.

If you are interested in consulting support  from Eisner Safety Consultants to help you through this transition, closer to when finalized, or for current MDD or AIMDD please feel free to contact us via the information at our contact us webpage.

The European Competent Authorities have formed a Central Management Committee (CMC) to achieve greater consistency in the interpretation and implementation of the requirements related to the medical devices sector (MDD, AIMDD & IVDD).  The CMC has issued decisions that need to be considered and implemented by medical device manufacturers.You can find the decisions at http://www.cmc-md.eu/decisions.html.  Four decisions have been issued to date:

1.     Classification and Boderline Queries (23FEB2011) – States classification decisions along with rationales for:

– Wound irrigation solutions containing antimicrobial agents (Class III under rule 13)
– System to determine bacterial contamination in blood products (falls under the IVDD)
– Qualification of Gallipots as medical devices (not a medical device)

2.     Notified Body Best Practice Guides (23FEB2011) – This does NOT affect manufacturers.  It lists the Notified Body Operations Group (NBOG) Best Practice Guides (NBP) and states that all notified bodies are expected to follow these best practices.

3.     Address of the Manufacturer and EU Representative (issued 23Feb2011, updated 7JUN2011) – The ‘address of the manufacturer’ as required in the Essential Requirements on the labels and instruction for use, is the address of the registered place of business of the legally responsible manufacturer and shall include:

– street/road,
– number/house/floor,
– postal code
– city
– state/region and
– country

The same details have to be provided for the address of the authorized representative.
NOTE:  This is more extensive that what the FDA typically requires for an address.

4.     Readability of Instructions for Use (14MAR2012) – It must be assured, that patients and professionals may use the devices as intended by the manufacturer and any ambiguities with regard to the proper and safe use due to deficiencies in the readability of IFUs are avoided.  To that end:

a.     Appropriate checks should be performed by the manufacturer on suitable samples of target users whether IFUs are  really readable and assure proper and safe use of the device.  This includes consideration of font size, quality of translations, and understandability of texts and graphics.
b.     Post-market surveillance procedures have to be sensitive to any indications of bad readability via vigilance or other channels and to any necessary corrective measures.
c.     Special care has to be taken to enable users to properly identify changes to the previous version of the IFU on the basis of a risk assessment.

As dates/revisions are not posted with the document titles, it may be difficult to determine at-a-glance if the decisions have been updated.  Please take care when checking for updates that you inspect the document of interest.

Notified Bodies have been asked to audit these particular points.  You should anticipate that some or all of these issues will be reviewed during your next audit.

If you have any questions on this matter please feel free to contact us at Leo@EisnerSafety.com.

The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical devices. Also, you can find the UK transposed regulations and many other useful items such as classification information, borderline documents, the conformity assessment process, regulatory news, details on revisions of the MDD, Vigilance, Notified Bodies, and much much more. The site links you to multiple places to the Europa website for things such as the Interpretation & guidance documents and more…

If you are looking for information on Medical Devices under the MDD this is a good link to look at for lots of information on the subject.

If you are looking for information on Medicines legislation & directives this is a good link to look at for lots of information on the subject.

They even set-up a page for New Technologies Forums for both Medicines and Medical Devices.