WRITTEN QUESTION No. 2312/98 by Riccardo NENCINI to the Commission. Directive 93/42/EEC
Date: 1998-07-22
Institutions: European Parliament, NENCINI
Subjects: EC Directive, Italy, application of EU law, harmonisation of standards, medical device, optical industry, optics, paramedical profession, public health, radiobiology

C 96/72

Official Journal of the European Communities

EN

8.4.1999

(1999/C 96/101)

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(cid:146)s interpretation of this legislation as regards its application to opticians is as follows: (cid:145)the legislation
in question does not apply to those carrying out the auxiliary profession of optician(cid:146) (ministry of health circular of
12.6.98), which completely contradicts the ministry(cid:146)s earlier interpretation. The auxiliary medical profession of
optician is perfectly compatible with the above directive because opticians entirely match the description of
(cid:145)manufacturer(cid:146) 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.

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.

(1999/C 96/102)

WRITTEN QUESTION E-2313/98

by Riccardo Nencini (PSE) to the Commission

(22 July 1998)

Subject: University qualification

Mr Simone Casamonti (Italian) was awarded the degree of (cid:145)Doctor of Philosophy in Environmental Engineering(cid:146)
by the Golden State University of Honolulu (Hawaii, USA) in 1995. It is not clear whether with this degree it is
possible to pursue the above profession in a European Union country.

Can the Commission clarify this point and say specifically whether the above qualification enables its holder to
work as a member of a profession in a European Union country.

Answer given by Mr Monti on behalf of the Commission

(2 October 1998)

As the Honourable Member himself indicates, the degree awarded in the United States is a university
qualification. Now, the exercise of a regulated profession requires the possession of a professional qualification,
and this may include, in addition to an academic qualification, the completion of training periods or the sitting of
professional examinations.

Provided that it is regulated, a professional activity carried on in the engineering sector falls within the scope of
Council Directive 89/48/EEC of 21 December 1988 on a general system for the recognition of higher-education
diplomas awarded on completion of professional education and training of at least three years(cid:146) duration (1).
In accordance with Article 1(a) of the Directive, the education and training attested by the diploma must have
been received mainly in the Community or the holder must have three years(cid:146) professional experience certified by
the Member State which recognised a third-country diploma.