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 Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207/2012 was released 10 March 2012.  Here’s a general summary:

• The directive does not cover IVDD devices which have their own guidance document.
• In general, an e-IFU is allowed for:
• AIMDD and MDD devices intended exclusively for professional use where use by other persons is not reasonably foreseeable.
• MDD device fitted with a built-in system visually displaying the instructions for use.
• It is important to read the full requirements.  Below is a summary of some key items.
• A documented risk analysis is required covering at least the items listed in Article 4 of the e-IFU directive (intended users’ access to hardware and software to view the e-IFU, intended use environment and access to e-IFU at time of use, etc.).  BSI provided a link, e-IFU REGULATION RISK ASSESSMENT SURVEY, to a general survey which may help avoid the need to run individual surveys.  As with all risk analyses, it must be updated based on experience from the post-marketing phase.
• Information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device must be provided with the device.  The information may be on the device or on a leaflet sent with the device.
• Instructions must remain available:
• For 2 years after the expiry date of the last produced device.
• For 15 years after the last device has been manufactured for:
• Devices without an expiry date.
• Implantable devices.
• There are specific requirements when the e-IFU is available through a website such as server downtime and display errors must be reduced as far as possible, and access must meet directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 
• Hardcopy of the IFU must be provided no later than 7 days from request and at no charge to the user.
• As of March 2013, the Notified Body will need to review compliance (with the exception of Class I MDD devices).

Additional requirements may apply to specific devices based on relevant standards.  For example, from EN 60601-1:2006 (same as IEC 60601-1:2005):

• For medical devices, clause 7.9.1 states, “ACCOMPANYING DOCUMENTS may be provided electronically, e.g. electronic file format on CDROM.  If the ACCOMPANYING DOCUMENTS are provided electronically, the RISK MANAGEMENT PROCESS shall include consideration of which information also needs to be provided as hard copy or as markings on the ME EQUIPMENT, e.g. to cover emergency operation.”
• For medical systems, clause 16.2 states, “NOTE ACCOMPANYING DOCUMENTS can be provided electronically, e.g. electronic file format or CD-ROM, for an ME SYSTEM capable of displaying or printing those documents.”