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 .

Several European medical device guidance documents (MEDDEVs) have been newly released or updated as noted below.  A brief note of significant points is provided.

–        MEDDEV 2.12/1 Medical devices vigilance system (UPDATED – March 2012):

o   Changes that will likely affect your current procedures are:

§  2 new report forms (Annex 7 – Trend Report Form and Annex 6 – Periodic Summary Report Form), and
§  updates to 2 existing report forms (Annex 3 – Incident Report Form and Annex 4 – FSCA Form).

o   The revised guidance is applicable as of 15JUN12.
o   Overall, the content of the guidance has not changed significantly.  Minor changes appear in Section 4.5 – EUDAMED, Section 4.18 – Trend Reporting, Section 5.1.2 – Summary Reporting, Section 5.1.3.6 – Negligible Likelihood, Section 5.1.4 – Trend Reports, Section 6.3.1 – Circumstances (Coordinating NCA), Section 6.3.5 – Information between NCAs, Annex 1 – Examples, Annex 2 – Extracts from Directives, and Annex – GHTF Documents Used.  The numbering of some Annexes has changed.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6_mir_en.pdf.  Also see the Manufacturer Incident Report (MIR), http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6_mir_en.pdf; How to Use the MIR, http://ec.europa.eu/health/medical-devices/files/meddev/mir_use_en.pdf; and Field Safety Corrective Action report form, Field Safety Corrective Action.

–        MEDDEV 2.12/2 Post Market Clinical Follow-up (PMCF) studies (NEW):

o   Guidance provides insights into when a PMCF study should be considered, general principles for conducting a PMCF study, use of PMCF study data, and the role of the Notified Body.
o   The Notified Body is now required to “verify that PMCF is conducted when clinical evaluation was based exclusively on clinical data from equivalent devices”.  Any plan to justify no PMCF study in this case should be reviewed with your Notified Body at the earliest date possible.
o   Note that incidents that occur during PMCF studies conducted with CE marked devices within their intended uses are subject to Vigilance reporting requirements.
o   The guidance does not apply to IVD devices.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_12_2_ol_en.pdf. 

–        MEDDEV 2.5/10 Guideline for Authorised Representatives (NEW – January 2012) [only applies with the manufacturer is outside the EU]:

o   Guidance clarifies what the Representative is required to do (e.g., keep Declarations of Conformity and Technical Documentation at the disposal of the national authorities) and discusses what the Representative may be requested to do.
o   It also clarifies that a Representative is required for devices intended for clinical investigations.
o   Per the guidance, a contract is considered vital.  I recommend that you review the current contract with your Representative to ensure that all points noted in this guidance are addressed in the contract.
o   Available at http://ec.europa.eu/health/medical-devices/files/meddev/2_5_10_ol_en.pdf.

 –        MEDDEV 2.1/6 Qualification and Classification of stand alone software (NEW – January 2012):

o   Guidance walks you through how to determine if software is a standalone device.
o   It also describes how to determine its MDD classification or select the IVDD Annex.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf.

 –        MEDDEV 2.14/1 IVD Medical Device Borderline and Classification issues. A guide for manufacturers and notified bodies (UPDATED – January 2012):

o   Guidance walks you through:

§  deciding whether a device is a general laboratory or IVD device;
§  deciding whether a device falls under the IVDD or MDD; as well as
§  addressing kits that contain IVD devices, medical devices and other components.

     The manufacturer’s stated intended use is key to addressing these issues.

o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_14_1_rev2_ol_en.pdf.

–        MEDDEV 2.2/4 Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products (NEW – January 2012):

o   Guidance discusses how to determine, based on mode of action, when IVF/ART products fall under the MDD.
o   It describes issues to consider to address each MDD essential requirements along with most market considerations for traceability, vigilance, post-market clinical follow-up, and design modifications.
o   It also walks you through how to determine classification (usually Class III per Rule 13 as most incorporate one or more medicinal products).
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4_ol_en.pdf. 

–        MEDDEV 1.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP (NEW – January 2012):

o   Guidance is specific to variant Creutzfeldt-Jakob Disease (vCJD) [CJD is commonly called “mad cow” disease].
o   As the current Common Technical Specifications (CTS) cannot be adapted easily to vCJD assays, the guidance identifies basic quality requirements for vCJD assays.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_14_4_ol_en.pdf.

The full list of MEDDEVs is available at http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm.  

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The next 2 blog postings are thx to Erik Vollebregt who is a Life Sciences and IP (Intellectual Property) lawyer based in Amsterdam and is one of the founding partners of Axon Lawyers.  His posting is titled:

+ New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced
+ New MEDDEV on authorised representatives: everything you know is wrong

Erik has a blog that I visit frequently for EU MDD & AIMDD information.  Erik & I communicate on occasion to discuss various EU issues related around the EU MDD & AIMDD.  He has been a great resource of information to Eisner Safety Consultants.