Richtlijn 1990/385 - Harmonisatie van nationale wetgeving inzake actieve implanteerbare medische hulpmiddelen - Hoofdinhoud

SUMMARY OF:

Directive 90/385/EEC on the approximation of the laws relating to active implantable medical devices

WHAT IS THE AIM OF THE DIRECTIVE?

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  As part of the European Union (EU) regulatory framework on medical devices*, it seeks to harmonise 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 placed on the market in any EU country.

KEY POINTS

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  The devices must be designed and manufactured in a way that poses no risk to patients, medical personnel or others in contact with them.
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  Every device must bear standard information, where possible by using generally recognised symbols, on its sterile pack and sales packaging.
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  Devices meeting all the requirements bear the CE marking and may be placed on the market throughout the EU.
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  National authorities must take off the market any defective devices which it is found could harm patients, users or others.
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  The legislation does not apply to medicines for human use, human blood or transplants, or tissues or cells of human or animal origin.
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  In 2013, the Commission adopted an implementing act, Implementing Regulation (EU) No 920/2013 on designating and supervising notified bodies under Directive 90/385/EEC and Council Directive 93/42/EEC on medical devices (see summary). This regulation was subsequently amended by Regulation (EU) 2020/666 following the outbreak of the COVID-19 pandemic, in spring 2020.
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  Regulation (EU) 2017/745 (see summary) originally partly repealed Directive 90/385/EEC from 26 May 2020. However, following the outbreak of the COVID-19 pandemic, in order to take the pressure off national authorities, notified bodies, manufacturers and other actors to allow them to focus fully on urgent priorities related to the coronavirus crisis, amending Regulation (EU) 2020/561 postponed the date of application for most rules under the medical devices regulation by 1 year – until 26 May 2021.

FROM WHEN DOES THE DIRECTIVE APPLY?

It has applied since 3 July 1990 and had to become law in the EU countries by 1 July 1991. It will be repealed as from 26 May 2021.

BACKGROUND

For more information, see:

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  Medical devices – Sector – Overview (European Commission)
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  Medical devices – Sector – Current directives (European Commission).

KEY TERMS

Medical device: term covering a wide variety of products used, for instance, for:

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  diagnosis, prevention, monitoring, treatment or alleviation of a disease;
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  diagnosis, monitoring, treatment, alleviation or compensation of an injury or handicap;
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  investigation, replacement or modification of the human body anatomy or of a physiological process;
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  control of conception.

It does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.

The complete definition of the term ‘medical device’ is laid down in Article 1(2)(a) of Directive 90/385/EEC.

Active implantable medical device: an active medical device (a device which, for its functioning, relies on electrical energy or a power source other than that directly generated by the human body or gravity) intended to be totally or partially introduced, surgically or medically, into the human body.

The complete definition of the term ‘active implantable medical device’ is laid down in Article 1(2)(c) of Directive 90/385/EEC.

MAIN DOCUMENT

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 (OJ L 189, 20.7.1990, pp. 17-36)

Successive amendments to Directive 90/385/EEC have been incorporated into the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, pp. 1-175)

See consolidated version.

Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L 253, 25.9.2013, pp. 8-19)

See consolidated version.

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)

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 (OJ L 212, 9.8.2012, pp. 3-12)

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

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, pp. 1-43)

See consolidated version.

last update 01.02.2021

Deze samenvatting is overgenomen van EUR-Lex.