Medical devices are used to diagnose, treat or relieve illnesses. More than half a million different medical devices are used in hospitals, nursing homes and in private homes. Examples are syringes, surgical instruments, pacemakers, breast and hip implants, crutches, condoms, dentures, glasses, patches or pregnancy tests.
The rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s and are presently in the process of being revised.
The European Commission proposals for a new legal framework (adopted on 26.09.2012: Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009; Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices) foresee a stronger role for the Commission in the management of the future system, ensuring a harmonised interpretation and implementation of the future regulations and enhanced coordination between national authorities in the areas of their competences (e.g. Notified Bodies' oversight, clinical investigations, vigilance, and market surveillance).
The Joint Research Centre provides scientific and technical support for the implementation and application of the European rules for medical devices.
See recent examples of JRC activities in this field:
- JRC Report "Total Hip Arthroplasty - State of the Art, Challenges and Prospects" (July 2012)
- JRC, IRMM: A new reference material for C-reactive protein (November 2011)
Photo: Blood sugar test © Rolf Bruderer/Blend Images/Corbis.