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Document 01990L0385-20071011

Safe active implantable medical devices

Safe active implantable medical devices


The aim of this directive 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.


It harmonises national legislation on active implantable* medical devices. This ensures universally high safety standards for patients, giving the public confidence in the system. It enables the products to be used in any European Union (EU) country.


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.

Devices meeting all the requirements bear the CE marking and may be used throughout the EU.

National authorities must take off the market any defective devices which it is later found could harm patients, users or others.

The legislation does not apply to medicines for human use, human blood or transplants, tissues or cells of human or animal origin.


*Medical device: appliance, including the necessary software,

to diagnose, prevent, monitor, treat or alleviate disease or injury,

to diagnose, monitor, treat , alleviate or compensate an injury or handicap,

to investigate, replace or modify the human body or a physiological process,

as a contraceptive.

*Active medical device: medical device relying on electrical energy or power source other than that directly generated by the human body or gravity.

*Active implantable medical device: active medical device intended to be totally or partially introduced, surgically or medically, into the human body



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



Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 90/385/EEC



OJ L 189, 20.7.1990, pp. 17-36

Amending act(s)

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 93/42/EEC



OJ L 169, 12.7.1993, pp. 1-43

Directive 93/68/EEC



OJ L 220, 30.8.1993, pp. 1-22

Regulation (EC) No 1882/2003



OJ L 284, 31.10.2003, pp. 1-53

Directive 2007/47/EC



OJ L 247, 21.9.2007, pp. 21-55

Successive amendments and corrections to Directive 90/385/EEC have been incorporated into the basic text. This consolidated version is for information only.


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 (Official Journal L 212, 9.8.2012, pp. 3-12)

Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (Official Journal L 102, 23.4.2010, pp. 45-48)

Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, pp. 28-31)

Commission Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (OJ L 253, 25.9.2013, pp. 27-35)

last update 06.10.2015