WHAT IS THE AIM OF THE DIRECTIVE?

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.

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

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.

Medical devices must comply with strict safety and health requirements set out in the legislation.

Devices which meet these requirements are given a CE marking and can be placed on the market throughout the EU.

Medical devices are classified into different categories depending on their use.

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.

The legislation does not apply to:

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

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

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.

Regulation (EU) 2017/745 (see summary) originally repealed Directive 93/42/EEC, from 26 May 2020.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.

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

KEY TERMS

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

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

Ensuring medical devices are safe and efficient for patients

SUMMARY OF:

WHAT IS THE AIM OF THE DIRECTIVE?

KEY POINTS

FROM WHEN DOES THE DIRECTIVE APPLY?

BACKGROUND

KEY TERMS

MAIN DOCUMENT

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