Manufacturers incorporating electric components to medical devices may find a dilemma when addressing the conformity to the 3rd edition of the IEC 60601-1, in reference to medical devices already on the distribution channel or such devices about to be shipped out of the factory. What does the standard mean? What do you have to do as manufacturers of medical devices and systems to still be able to distribute your products on the European Market come June 2012 (when the 3rd edition of IEC 60601-1 shall be fully applicable).
The IEC 60601-1 is an established standard of safety regarding electro-medical equipment and its 2nd edition brought specific electromagnetic compatibility standards for medical electrical equipment and medical electrical systems.
From a regulatory/legal point of view, the medical devices shall comply at all times with the essential requirements.
At the time of design, compliance with the 2nd edition of the IEC 60601-1 was logic.
After June 2012, it is probable that the devices no longer comply with the standard, but they still may comply with the Essential Requirements.
How to tackle such predicament?
Obelis experts recommend to manufacturers of medical devices to perform an evaluation of comparison between the standard editions and on its basis, perform a risk analysis;
If after the analysis, the manufacturer can still present arguments that the devices comply with the essential requirements he can continue shipping to European Market (see note of warning!).
In his declaration of conformity he shall state more clearly with which of the standard they comply with.
Devices already in the distribution channel can be distributed as at the time of their entry to the distribution channel, they were compliant with the most relevant standard edition;
Note of Warning:
If after the analysis, the manufacturer shall arrive to the conclusion that these devices are no longer safe, he shall first invest in attaining conformity to the standard edition and then resume his sales.
The medical devices in the warehouse of the distributor are out of your control.
Do keep in mind that starting 1st of June 2012 the 3rd edition of the IEC 60601-1 will come into effect for medical electrical equipments entering the EU market. Moreover your products still need to fully comply with the requirements of the MDD 93/42/EEC and bear the CE marking affix.
Obelis, acting as European Authorized Representative (EAR) can provide you with the very best assistance in this matter and give sound advice on how to proceed to compliance with these requirements.