Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)

• Published date: 20 July 1990
• Subject Matter: ravvicinamento delle legislazioni,ostacoli tecnici,Mercato interno - Principi,aproximación de las legislaciones,obstáculos técnicos,Mercado interior - Principios,rapprochement des législations,entraves techniques,Marché intérieur - Principes
• Official Gazette Publication: Gazzetta ufficiale delle Comunità europee, L 189, 20 luglio 1990,Diario Oficial de las Comunidades Europeas, L 189, 20 de julio de 1990,Journal officiel des Communautés européennes, L 189, 20 juillet 1990

1990L0385 — EN — 11.10.2007 — 003.001

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This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) (OJ L 189, 20.7.1990, p.17)

Amended by:

		Official Journal
		No	page	date
►M1	COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993	L 169	1	12.7.1993
►M2	COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993	L 220	1	30.8.1993
M3	REGULATION (EC) No 1882/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 September 2003	L 284	1	31.10.2003
►M4	DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Text with EEA relevance of 5 September 2007	L 247	21	21.9.2007

Corrected by:

►C1 Corrigendum, OJ L 007, 1.11.1994, p. 20 (90/385)

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▼B

COUNCIL DIRECTIVE

of 20 June 1990

on the approximation of the laws of the Member States relating to active implantable medical devices

(90/385/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commission ( 1 ),

In cooperation with the European Parliament ( 2 ),

Having regard to the opinion of the Economic and Social Committee ( 3 ),

Whereas in each Member State active implantable medical devices must give patients, users and other persons a high level of protection and achieve the intended level of performance when implanted in human beings;

Whereas several Member States have sought to ensure that level of safety by mandatory specifications relating both to the technical safety features and the inspection procedures for such devices; whereas those specifications differ from one Member State to another;

Whereas national provisions ensuring that safety level should be harmonized in order to guarantee the free movement of active implantable medical devices without lowering existing and justified levels of safety in the Member States;

Whereas harmonized measures must be distinguished from measures taken by Member States to manage the financing of public health and sickness insurance schemes directly or indirectly concerning such devices; whereas, therefore, such provisions do not affect the right of Member States to implement the abovementioned measures in compliance with Community law;

Whereas maintaining or improving the level of protection achieved in Member States constitutes one of this Directive's essential objectives as defined by the essential requirements;

Whereas rules governing active implantable medical devices can be confined to those provisions needed to satisfy the essential requirements; whereas, because they are essential, these requirements must replace corresponding national provisions;

Whereas, in order to facilitate proof of conformity with these essential requirements and to permit monitoring of that conformity, it is desirable to have Europe-wide harmonized standards in respect of the prevention of risks in connection with the design, manufacture and packaging of active implantable medical devices; whereas such standards harmonized at European level are drawn up by private-law bodies and must retain their status as non-mandatory texts; whereas, to that end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as being the competent bodies to adopt harmonized standards in accordance with the general guidelines for cooperation between the Commission and these two bodies, signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by either or both of these bodies, as instructed by the Commission pursuant to the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations ( 4 ), as last amended by Directive 88/182/EEC ( 5 ), and under the abovementioned general guidelines;

Whereas evaluation procedures have to be established and accepted by common accord between the Member States in accordance with Community criteria;

Whereas the specific nature of the medical sector makes it advisable to make provision for the notified body and the manufacturer or his agent established in the Community to fix, by common accord, the time limits for completion of the evaluation and verification operations for the conformity of devices,

HAS ADOPTED THIS DIRECTIVE:

Article 1

1. This Directive shall apply to active implantable medical devices.

2. For the purposes of this Directive, the following definitions shall apply:

▼M4

(a) ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

— investigation, replacement or modification of the anatomy or of a physiological process,

— control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

▼B

(b) ‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;

(c) ‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;

▼M4

(d) ‘custom-made device’ means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;

(e) ‘device intended for clinical investigation’ means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.

For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;

(f) ‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;

▼B

(g) ‘putting into service’ means making available to the medical profession for implantation;

▼M1

(h) ‘placing on the market’ means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;

(i) ‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;

▼M4

(j) ‘authorised representative’ means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;

(k) ‘clinical data’ means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

— clinical investigation(s) of the device concerned, or

— clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or

— published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.

▼M4

3. Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC ( 6 ), that device shall be governed by this Directive, without prejudice...