WRITTEN QUESTION No. 2312/98 by Riccardo NENCINI Directive 93/42/EEC (SUPPLEMENTARY ANSWER)
12. 11. 1999 EN Official Journal of the European Communities C 325/1 I (Information) EUROPEAN PARLIAMENT WRITTEN QUESTIONS WITH ANSWER (1999/C 325/001) 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? (1) OJ L 169, 12. 7. 1993, p. 1. Supplementary answer given by Mr Bangemann on behalf of the Commission (25 March 1999) An optician’s professional activity is to prepare and assemble, under his own responsibility, corrective lenses on a suitable frame, as prescribed by a qualified practitioner for a particular person, to make the necessary adjustments and adaptations to take into account this person’s specific needs and then to place the final product at his disposal. The period for implementing Council Directive 93/42/EEC of 14 June 1993 concerning medical devices came to an end on 14 June 1998. The provisions of this Directive are applied throughout the Community, and Custom-made devices fall within its scope. Insofar as opticians manufacture this type of device, they have to comply with the provisions for custom-made devices set out in the Directive, as implemented in the national law of the Member States