Richtlijn 1993/42 - Medische hulpmiddelen - Hoofdinhoud

SUMMARY OF:

Directive 93/42/EEC concerning medical devices

WHAT IS THE AIM OF THE DIRECTIVE?

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  It aims to ensure a high level of protection for human health and safety and the smooth operation of the single market in the European Union (EU) and to achieve the results for which the medical devices* are intended.
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  It harmonises national legislation on medical devices. This ensures a high level of protection 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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  All medical devices available in the EU must be safe for patients, users and others when they are properly installed, maintained and used as they should be.
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  Medical devices must comply with strict safety and health requirements set out in the legislation.
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  Devices which meet these requirements are given a CE marking and can be placed on the market throughout the EU.
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  Medical devices are classified into different categories depending on their use.
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  National authorities must take off the market any devices found to harm people’s health. They must immediately inform the Commission and other EU countries of any malfunction or deterioration of a medical device.
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  The legislation does not apply to:

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    devices for in vitro diagnosis;
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    active implantable devices covered by Directive 90/385/EEC (see summary);
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    medicinal products for human use covered by Directive 2001/83/EC (see summary);
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    cosmetics covered by Regulation (EC) No 1223/2009 (see summary);
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    human blood products or transplants;
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    tissues or cells of human or animal origin; or
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    personal protective equipment.

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  In the framework of Council Directive 93/42/EEC concerning medical devices, additional legislation is in place for:

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    the reclassification of hip, knee and shoulder joint replacements;
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    the reclassification of breast implants; and
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    additional requirements for devices using tissue of 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 on active implantable medical devices and Council Directive 93/42/EEC on medical devices. 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 repealed Directive 93/42/EEC, from 26 May 2020. However, following the outbreak of the COVID-19 pandemic, 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 29 June 1993 and had to become law in the EU countries by 1 July 1994. It will be repealed as from 26 May 2021.

BACKGROUND

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  Medical Devices – Sector – Overview (European Commission).

KEY TERMS

Medical devices: 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 93/42/EEC.

MAIN DOCUMENT

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

Successive amendments to Directive 93/42/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 Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, pp. 41-43)

Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, pp. 43-44)

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)

See consolidated version.

last update 01.02.2021

Deze samenvatting is overgenomen van EUR-Lex.