legislation-profile

Active Implantable Medical Devices Directive

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

Scope

The aim of Directive 90/385/EEC is to ensure a high level of protection for human health and safety, smooth operation of the single market and to achieve the results for which the active implantable medical devices are intended. Under this Directive, active implantable medical devices are defined as 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.

Exemptions

This Directive shall not apply to: (a) medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product; (b) human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a; (c) transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a; (d) transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

Regulatory activities

The Directive specifies that active implantable medical devices must satisfy the Essential Requirements set out in Annex 1. The devices must be designed and manufactured in a way that poses no risk to patients, medical personnel or others in contact with them. Every device must bear standard information, where possible by using generally recognised symbols, on its sterile pack and sales packaging. National authorities must take off the market any defective devices which it is later found that could harm patients, users or others. Devices meeting all the requirements bear the CE marking and may be used throughout the EU.

Relevant product types

No reference data. The Directive does not contain any explicit list of substances and/or products.

Reference documents

Yes Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure Directive 2001/83/EC on the Community code relating to medicinal products for human use Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed)

Obligations based on CLP hazard class

No provision

Obligations based on properties of concerns

No provision

EU-level occupational exposure limits

No provision

EU-level emission limit values

No provision

Substance-centric data source(s) at the EU level

Yes European database on medical devices (EUDAMED). Its purpose is to strengthen market surveillance and transparency in the field of medical devices, by providing national competent authorities with fast access to information. EUDAMED is a secure, web-based portal, which serves as a central repository for information exchanged between MS national competent authorities and the Commission. It is not publicly accessible.

Industry submission system in place

No

Format for industry submission

Not applicable For EUROMED database, data must be forwarded in a standardised format.

Owner

DG GROW

Update process

Responsible notification bodies; MS authorities

Amendments

Council Directive 93/42/EEC of 14 June 1993 Council Directive 93/68/EEC of 22 July 1993 Corrigendum, OJ L 7, 1.11.1994, p. 20 Regulation (EC) No 1882/2003 of 29 September 2003 Directive 2007/47/EC of 5 September 2007