The Medical Device Directive 93/42 defines
medical devices and products, which combine a
drug with a device. For regulatory purposes, the
latter are subdivided and dealt with as follows:
Where device and drug are supplied separately
(e.g. syringes marketed empty), the device is
subject to devices controls and the medicine is
subject to medicines control.
Integral, non-reusable products intended solely
for use in the given combination (e.g. syringes
marketed prefilled) are subject to medicines con-
trol, but the device feature must satisfy the rele-
vant essential requirements of the directive
relating to safety and performance.
Devices incorporating a drug where the action of
the drug is ancillary to that of the device (e.g.
anticoagulant-coated catheters) are subject to
devices control, but the drug must be verified
by analogy with medicines control criteria and
the medicines licensing authority must be con-
sulted.
References and resources
World Medical Association Declaration of Helsinki.
Ethical principles for medical research involving
human subjects (as amended).
Pharmacos 4 – Eudralex. The rules governing medicinal
products in the European Union. (www.dg3.
eudra.org/F2/eudralex/index.htm).
Regulation 726/2004 of 31 March 2004 laying down
Community procedures for the authorisation and
supervision of medicinal products for human and
veterinary use and establishing a European Medi-
cines Agency.
Council Directive 65/65/EEC of 26 January 1965 on the
approximation of provisions laid down by law,
regulation or administrative action relating to pro-
prietary medicinal products (requirements for med-
icinal products on Quality, Efficacy, Safety).
Council Directive 75/318/EECon the approximation of
the laws of Member States relating to analytical,
pharmaco-toxicological and clinical standards and
protocols in respect of the testing of proprietary med-
icinal products (OJ L 147,9.6.1975), as last amended
by Directive 93/39/EEC (mutual recognition).
Council Directive 75/319/EEC on the approximation of
provisions laid down by law, regulation or admin-
istrative action relating to proprietary medicinal
products (OJ L 147, 9.6.1975), as last amended
by Directive 93/39/EEC (CPMP).
Directive EEC/2001/20 of the European Parliament and
of the Council of April 4, 2001 on the approximation
of the laws, regulations and administrative provi-
sions of the Member states relating to the imple-
mentation of good clinical practice in the conduct of
clinical trials on medicinal products for human use
(The new Clinical Trial Directive).
Directive 2001/83/EC of the European Parliament and
of the Council of November 6, 2001on the Com-
munity code relating to medicinal products for
human use (Classification of Medicines).
Directive 2001/83 Annex I of June 20, 2002 (License
variations).
Directive 2004/27/EC of March 31, 2004 amending
Directive 2001/83/EC on the community code relat-
ing to medicinal products for human use.
Directive 92/27/EC (labelling and patient information
leaflet).
Directive 91/356/EEC of June 13, 1991, laying down the
principles and guidelines of good manufacturing
practice for medicinal products for human use (GMP).
Directive 2003/94/EC of 8 Oct 2003 laying down
principles and guidelines of good manufacturing
practice in respect of medicinal products for human
use and investigational products for human use.
Directive 87/22/EEC (centralised procedure).
Directive 97/43/Euratom ‘Medical Exposure Directive’.
Directive 92/28/EC (advertising and promotion).
Medical Device Directive 93/42/EEC.
Directive 89/105/EEC of December 21, 1988, relating to
the transparency of measures regulating the pricing of
medicinal products for human use and their inclusion
within the scope of national health insurance systems
(transparency of price and reimbursement).
European Patent Convention Part II, 11th edition, July
2002.
EC Commission. Detailed guidance on the application
format and documentation to be submitted in an
application for an ethics committee opinion on the
clinical trial on medicinal products for human use.
April 2003 (Brussels, ENTR/F2/BL D (2003)).
EC Commission. Detailed guidance for the request for
authorisation of a clinical trial on a medicinal product
for human use to the competent authorities, notifica-
tion of substantial amendments and declaration of theREFERENCES AND RESOURCES 483