As I'm sure you are all aware the European Commission set out proposals for changes to the Medical Device Directive (and IVDD) in autumn 2012.
(link)
http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm
In the UK our 'Competent Authority', the MHRA has been conducting a public consultation on the proposed changes.
(Consultation)
http://www.mhra.gov.uk/Publications/Consultations/Deviceconsultations/CON205361
They have know published a response to the comments they received, which is worth a look.
(Response)
http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con260309.pdf
There is no need to get too worried yet - the changes will not happen for several more years.
(link)
http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm
In the UK our 'Competent Authority', the MHRA has been conducting a public consultation on the proposed changes.
(Consultation)
http://www.mhra.gov.uk/Publications/Consultations/Deviceconsultations/CON205361
They have know published a response to the comments they received, which is worth a look.
(Response)
http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con260309.pdf
There is no need to get too worried yet - the changes will not happen for several more years.