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Changes to the Medical Device Directive

4/5/2010

Changes to the Medical Device Directive (93/42/EEC) introduced by amending Directive 2007/47/EC came into force on 21 March 2010.  There are important consequences for manufacturers of medical devices, relating to conformity assessments; clinical evaluation and investigations; and application of the classification rules.  Manufacturers need to ensure that their devices, including those CE-marked before this date, are in compliance with the revised essential requirements.

Wainwright Associates’ consultants can provide advice on the implications of these changes, please contact us to see how we can help.