Details of harmonised standards under the medical devices directives

The updated data is given in bold. In the instances where standards have been superseded by later versions, but the earlier version still has a presumption of conformity, the earlier version remains in grey with a note relating to the cessation of the presumption of conformity. These entries will be removed once the date for the presumption of conformity has expired. Standards that are out of date have been removed; these removals are not indicated.

Each relate to:

• general medical devices (183Kb)
• active implantable medical devices (73Kb)
• In-vitro diagnostic medical devices (74Kb)

The previous published lists from March 2010 are also available:

• general medical devices (209Kb)
• active implantable medical devices (35Kb)
• In-vitro diagnostic medical devices (30Kb)

The previous published lists from November 2009 are also available:

• general medical devices (456Kb)
• active implantable medical devices (72Kb)
• In-vitro diagnostic medical devices (61Kb)

The previous published lists from July 2009 are also available:

• general medical devices (292Kb)
• active implantable medical devices (124Kb)
• In-vitro diagnostic medical devices (138Kb)

The previous published lists from March 2009 are also available:

• general medical devices (527Kb)
• active implantable medical devices (130Kb)
• In-vitro diagnostic medical devices (140Kb)

The previous published lists from November 2008 are also available:

• general medical devices (483Kb)
• active implantable medical devices (136Kb)
• In-vitro diagnostic medical devices (73Kb)

The previous published lists from July 2008 are also available:

• general medical devices (584Kb)
• active implantable medical devices (161Kb)
• In-vitro diagnostic medical devices (135Kb)

The previous published lists from May 2007 are also available:

• general medical devices (164Kb)
• active implantable medical devices (32Kb)
• In-vitro diagnostic medical devices (27Kb)

The previous published lists from January 2007 are also available:

• general medical devices (171Kb)
• active implantable medical devices (36Kb)
• in-vitro diagnostic medical devices (30Kb)

The previous published lists from September 2006 are also available:

• general medical devices (161Kb)
• active implantable medical devices (33Kb)
• in-vitro diagnostic medical devices (28Kb)

The previous published lists from May 2006 are also available:

• general medical devices (130Kb)
• active implantable medical devices (25Kb)
• in-vitro diagnostic medical devices (28Kb)

The previous published lists from January 2006 are also available:

• general medical devices (145Kb)
• active implantable medical devices (25Kb)
• in-vitro diagnostic medical devices (28Kb)

These lists will be published quarterly on the MHRA website. If you require further details in relation to a particular standard, please contact BSI on telephone number 020 8996 9000.