Medical devices directives

Revised medical devices directives will enter into force on March 21, 2010, affecting manufacturers, importers, distributors, authorised representatives, notified bodies, users of healthcare facilities and users of self-testing devices at home.

The text that will amend directives 93/42/EEC and 90/385/EEC was published on September 21 and can be found at http://eur-lex.europa.eu/ LexUrerv/LexUriServ.do?uri=OJ:L:2007:247:0021:01:EN:HTML.

The overall objectives of the amendment are to ensure the highest level of safety and improve competitiveness, especially in the light of technical innovation and the development of initiatives at international level.

For further information or queries one the Malta Standards Authority on 2124 2420 or send an e-mail to david.pulis@msa.org.mt or tristan.camilleri@msa.org.mt .