Ensuring medical devices are safe for patients

 

SUMMARY

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 devices are intended.

WHAT DOES THE DIRECTIVE DO?

It harmonises national legislation on 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 country.

KEY POINTS

• National authorities must ensure that all medical devices available in the EU are safe for patients, users and others when they are properly installed, maintained and used as they should be.
• Medical devices must comply with strict health and safety requirements set out in the legislation.
• Devices which meet these standards are given a CE marking and can be used throughout the EU.
• Medical devices are classified into different categories depending on the use to which they are put.
• 2 committees - one on standards and technical regulations, the other on medical devices - provide advice to the Commission on implementation of the legislation.
• National authorities must take off the market any devices which are later 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 which may come to light.
• Specific rules are set out for medical devices used for clinical trials.
• The legislation does not apply to active implantable devices or those used for in vitro diagnosis, medicinal products for human use, cosmetics, human blood products or transplants, tissues or cells of human or animal origin, or personal protective equipment.
• Additional legislation is in place for hips, knees and shoulders replacements, breast implants, and devices using tissue of animal origin.

KEY TERM

*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.

BACKGROUND

• Regulatory framework
• Medical devices
• Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
• Commission Recommendation (EU) 2020/518 of 8 April 2020 on a common Union toolbox for the use of technology and data to combat and exit from the COVID-19 crisis, in particular concerning mobile applications and the use of anonymised mobility data

ACT

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

RELATED ACTS

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

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 of 9.8.2012, pp. 3-12)

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 of 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 of 4.2.2003, pp. 43-44)

Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105 of 26.4.2003, pp. 18-23).

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 of 25.9.2013, pp. 27-35).

last update 28.05.2020