The Consumer and Industrial Goods Directorate of the Malta Standards Authority, within the Ministry for Competitiveness and Communications, said it has closely followed and participated in the discussions at European level on the revision of the medical devices directives.

In order to prepare Malta’s position the authority has consulted various interested parties in public and private. Discussions started in January 2006 and ended with the approval by both the European Council and the European Parliament in March 2007.

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

The package foresees a 15-month transposition period for national authorities and a further 15-month transition period for industry. This means that new Legal Notices will be published in this regard by December 2008, but the new text will only enter into force from 21 March, 2010.

Examples of medical devices include hospital and surgical equipment, prosthetics, pacemakers, dental appliances, contact lenses, vision correction glasses and self-testing kits. 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. Some of the most important changes in the text are:

•enhanced provisions on clinical evaluation;

•requirements for a post-production assessment of products and incident investigations now covers a wider variety of devices;

•provisions to allow information supplied by the manufacturer to be available by other means rather than paper;

•increased flexibility in the choice of compliance modules for certain categories of devices;

•provisions for a more consistent application of health protection measures;

•information related to registration of devices, vigilance data and certification will be more easily accessible to the public;

•obligations for Member States to cooperate more with each other and at international level;

•increased safety requirements for the design phase of production;

•limits on the use of substances that are carcinogenic, mutagenic or toxic to reproduction in medical devices;

•clarification regarding drug-device combinations; and

•basis for better co-ordination and communication of market surveillance activities.

The authority said that although 2010 may seem to be a long way away, stakeholders are encouraged to start preparing themselves as early as possible.

The revised Medical Devices Directives will affect manufacturers, importers, distributors, authorised representatives, notified bodies, users in a healthcare facility and users of self-testing devices at home.

Any person who requires further information or has any queries on this issue may contact the Malta Standards Authority (tel: 2124-2420 or by email at: david.pulis@msa.org.mt or tristan.camilleri@ msa.org.mt