Re: CE Certificate is valid until 3.12.2013 - Can I still sell the products in Europe
Sorry, jumping in on this late but I want to be sure I understand it. Since 60601 ed 3 is the current harmonized standard, isn't this a case where the use of this version of the standard presumes conformity to the ER's of the directive (and is obviously easier for the NB to assess?) As always, if a manufacturer chooses not to follow the current harmonized standards then the burden of proof for meeting the ER's is on them and this is more difficult for both the mfr and the NB. My experience has been that upon recertification, "state of the art" means complying with current standards or justifying why you are not (of which a part may be the post-market data that you have collected regarding safety/performance per Steve's comments).
Sorry, jumping in on this late but I want to be sure I understand it. Since 60601 ed 3 is the current harmonized standard, isn't this a case where the use of this version of the standard presumes conformity to the ER's of the directive (and is obviously easier for the NB to assess?) As always, if a manufacturer chooses not to follow the current harmonized standards then the burden of proof for meeting the ER's is on them and this is more difficult for both the mfr and the NB. My experience has been that upon recertification, "state of the art" means complying with current standards or justifying why you are not (of which a part may be the post-market data that you have collected regarding safety/performance per Steve's comments).