May be from Aug 2012, the CB's will issue the ISO13485:2003 + EN ISO13485:2012 as two separate certificates on request from customers that they need this to align with the EU harmonized standards.... Similar to the CMDCAS ISO13485.
Is there any listing in the EU as to who are the recognized registrars who can certify to EN ISO13485:2012 ?
One of the main problems with this is : a 13485 certificate is NOT required to show compliance with the MDD. What is required is to show conformity with the essential requirements.
For EN ISO 13485:2012 (which corrects some of the linking problems with the presumption of conformity in older version), if you look into the annexes you will verify that only some clauses give presumption of conformity with some parts of the MDD.
What an NB would need to do is:
1 - ask the manufacturer if they are using a standard to gain presumption of conformity
2 - if so, they need to addres which standard it is (and if it's not an harmonized one, the standard cannot give presumption of conformity)
2 - for the harmonized standard, verify, in the annexes, which clause gives presumption of conformity with any essential requirement (or, in the case of EN 13485, to which part of Annex 2 the clauses give presumption of conformity)
3 - for those, verify that the manufacturer is is conformance with the clause of the standard
4 - verify if there are any other requirements of the directive which needs another round of verification (for example, directive requirements which are not covered by the clauses evaluated)
Or something like that.
However, to simplify stuff (and get more money :-)) NBs, usually sells the idea that an EN ISO 13485 certificate is required. Nothing against that, and it's great from the point of view that you can maybe use the certificate on other regulatory systems, but again, formaly, only a certificate to EN ISO 13485 give a presumption of conformity.