Why do I need to classify my product for IEC 60601-1, 3^rd ed.? – The standard says you have to classify“…ME EQUIPMENT, or parts thereof, including applied parts…” as noted in sub-clause 6.1 of IEC 60601-1, 3^rd ed or 3^rd ed. with Amendment 1 of the standard.. But a more practical reason you would want to classify your products that fall under the scope of IEC 60601-1 (http://bit.ly/60601scope) is it is a helpful tool in identifying the requirements that apply to the device, and helps us in determining the test plan for the product to be tested.

This blog discusses the following FAQ’s:

• What are the various classifications that are used in IEC 60601-1, edition 3.1?
• What is an applied part? 
• What are the classifications for Protection Against Electric Shock? 
• Power Sources – External Class I, External Class II or Internal
• Applied Parts – B, BF, CF (also defibrillation-proof)
• Why do we have classifications for protection against electric shock?
• What are the classifications for protection against harmful ingress of water or particulate matter?
• Why do we have classifications for protection against harmful ingress of water or particulate matter?
• What are the classifications for methods of sterilization?
• Why do we have classification for the suitability in an oxygen rich environment?
• What are the classifications for modes of operation?

• Essential Principles of Safety & Performance of Medical Devices GHTF/SG1/N68:2012 supersedes GHTF/SG1/N41:2005
• Principles of Conformity Assessment for Medical Devices GHTF/SG1/N78:2012 supersedes GHTF/SG1/N40:2006
• Principles of Medical Devices Classification GHTF/SG1/N77:2012 supersedes GHTF/SG1/N15:2006
• Quality Management System – Medical Devices – Nonconformity Grading System for Regulatory Purposes & Information Exchange GHTF/SG3/N19:2012
• Clinical Evidence for IVD Medical Devices – Clinical Performance Studies for In Vitro Diagnostic Medical Devices GHTF/SG5/N8:2012
• Clinical Evidence for IVD Medical Devices – Scientific Validity Determination & Performance GHTF/SG5/N7:2012
• Clinical Evidence for IVD Medical Devices – Key Definitions & Concepts GHTF/SG5/N6:2012

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.