Arterial stent standard: BS EN 14299:2004 will cease to give MDD Presumption of Conformity as of 21 March 2010

 

BS EN 14299:2004 Superseded


Those using the arterial stent standard BS EN 14299:2004 should be aware that it will no longer give presumption of conformity to the Medical Devices Directive (MDD) 93/42/EEC as of 21 March 2010.

It has been superseded by the recently published BS EN ISO 25539-1:2009 Cardiovascular implants. Endovascular devices. Endovascular prostheses and BS EN ISO 25539-2:2009 Cardiovascular implants. Endovascular devices. Vascular stents.

The date of withdrawal coincides with the enforcement date of the amended MDD and will impact any medical devices manufacturers that CE mark their products.

This may have an impact on some Medical Device Manufacturers as the previous date has been moved up from 30 September 2011. It is advisable for manufacturers who use these standards to accelerate transition to the new Standards in order to stay compliant.

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