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. 2001 Sep;52(3):229-35.
doi: 10.1046/j.0306-5251.2001.01416.x.

The regulation of medical devices and the role of the Medical Devices Agency

D B Jefferys  1
Affiliations

The regulation of medical devices and the role of the Medical Devices Agency

D B Jefferys. Br J Clin Pharmacol. 2001 Sep.

Abstract

This article reviews the regulation of medical devices in the UK and Europe and compares the regulatory regime with that for pharmaceuticals. The regulation of devices follows the 'New Approach' policy of the EC Commission and involves more self-regulation and conformity assessment. The controls are relatively recent beginning in 1993 for Active Implantable Devices and concluding with the In Vitro Diagnostic Directive implemented in June 2000. The article describes how the directives have been implemented in the UK, the role of the Notified Bodies and the role of the Medical Device Agency (MDA) as the competent authority. In particular the Agency's compliance and standards work is described along with the strategy and post marketing surveillance and adverse incident scheme. The MDA is a key international device regulatory agency and its international role is discussed. So too is its device evaluation programme for the NHS and how this complements the work of NICE. The article also considers the future direction of the MDA and changes in the device sector.

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Figures

Figure 1
Figure 1
Conformity assessment-relationship between the control procedure and the product class.
Figure 2
Figure 2
The number of adverse incident reports over the period 1991–2000.
Figure 3
Figure 3
The causes of adverse incidents reported during April 1999–March 2000.
Figure 4
Figure 4
The more significant outcomes of investigations during 1990–2000.
See this image and copyright information in PMC

References

    1. European Commission. Guide to the implementation of directives based on the New Approach and the Global Approach. Luxembourg: Office for Official Publications of the EC; 2000. ISBN 92–828–7500–8.
    1. MDA Annual Report and Accounts 1999–2000. 2000. The Stationary Office. ISBN 0–10–556874–0.
    1. MDA Business Plan 2000–2001. 2000. (available on request from MDA or on the http://www.medical-devices.gov.uk)
    1. MDA Directives Bulletin No4. Conformity Assessment Procedures. 1999. available on request from MDA or on http://www.medical-devices.gov.uk.