Focus on

The Official Journal of the European Union of 18 February 2004 publishes the reference to the standard EN ISO 14971:2000/AC:2002 Medical devices - Application of risk management to medical devices in the framework of the Directive 90/385/EEC on active implantable medical devices. That standard is since then considered as "harmonised" and therefore confers a presumption of conformity to the directive when used for the design and production of such devices.

The reference of that standard was previously published on 31 July 2002 in the framework of directives 93/42/EEC concerning medical devices and 98/79/EC on in vitro diagnostic medical devices.

Read the corresponding communication in: English, français, nederlands.

CEBEC
Av. F. Van Kalkenlaan
9A / box 1
B-1070 Brussels
(Belgium)

t: + 32 (0)2 556 00 20
f: + 32 (0)2 556 00 36
E-mail

The SGS Group is the global leader and innovator in inspection, verification, testing and
certification services. Founded in 1878, SGS is recognized as the global benchmark in
quality and integrity. With more than 48’000 employees, SGS operates a network of over
1’000 offices and laboratories and laboratories around the world.