91998E2312

WRITTEN QUESTION E-2312/98

by Riccardo Nencini (PSE) to the Commission

(22 July 1998)

Subject: Directive 93/42/EEC

On the 15 June 1998 Directive 93/42/EEC(1) concerning medical devices came into force. The Italian government's interpretation of this legislation as regards its application to opticians is as follows: "the legislation in question does not apply to those carrying out the auxiliary profession of optician" (ministry of health circular of 12.6.98), which completely contradicts the ministry's earlier interpretation. The auxiliary medical profession of optician is perfectly compatible with the above directive because opticians entirely match the description of "manufacturer" in that they are professional technicians who produce only tailor-made devices with a view to their being placed on the market under their own name. All countries except for Belgium have interpreted Directive 93/42/EEC as covering opticians by virtue of their manufacturing or assembly activities.

Does the Commission consider it necessary to take steps in order to press for the Italian government to adopt an interpretation of Directive 93/42/EEC that is more in accordance with its content?

Answer given by Mr Bangemann on behalf of the Commission

(14 October 1998)

The Commission has asked the Member State concerned for information regarding the facts raised to by the Honourable Member. It will inform him of its findings.

(1) OJ L 169, 12.7.1993, p. 1.