Medical  Device  &  QA  Consultancy
     
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QUICK LINKS

EDMA to GMDN Codes Conversion: http://www.edma-ivd.be/EDMAGMDN/EDMA_GMDN_Codes.rtf

GMDM to EDMA Codes Conversion: http://www.edma-ivd.be/EDMAGMDN/GMDN_EDMA_Codes.rtf

IVD - EDMA Codes: http://www.mdqaconsultancy.co.uk/ivd/EDMA%20prod%20codes%20ver%205.pdf

IVD Directive 98/79/EC: http://www.mdqaconsultancy.co.uk/client/regulations/98_70_ec.pdf

IVD Directive: Annex I: http://www.mdqaconsultancy.co.uk/ivd annex I.pdf

IVD Directive: Annex I ER # 8.4: LABEL: http://www.mdqaconsultancy.co.uk/ivd label & ifu.pdf

IVD Directive: Annex I ER # 8.7: USER INSTRUCTIONS: http://www.mdqaconsultancy.co.uk/ivd label & ifu.pdf

IVD Directive: Annex II: http://www.consultancy.co.uk/ivd annex II.pdf

IVD - EDMA Codes (Nov 2004): http://www.edma-ivd.be/Classification/CIP_INPUT_FORM_With_Instruments.xls

Consumer rights 99/44/EC: http://www.mdqaconsultancy.co.uk/client/regulations/ 99-44-EC consumer ri..>

 

 

 

European Economic Area countries: http://www.mdqaconsultancy.co.uk/eea%20list.html

 Directives: http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html

MEDE guidance documents: http://europa.eu.int/comm/enterprise/medical_devices/meddev/index.htm

MHRA Website (UK Notified Bodies)

http://www.medical-devices.gov.uk/mda/mdawebsitev2.nsf/webvwIndex/830D7042368A257A00256A8F00364E1D?OPEN

MHRA website (Regulatory Guidance Notes):

http://www.medical-devices.gov.uk/mda/mdawebsitev2.nsf/webvwRegulatoryPublications/0A5E025F3BAC561180256BF100387FD3?OPEN

MHRA Website (Directives Bulletins):

http://www.medical-devices.gov.uk/mda/mdawebsitev2.nsf/webvwRegulatoryPublications/4AD7935B0D0DE7EB80256D0800320403?OPEN

MHRA Website (Vigilance Guidance):

http://www.medical-devices.gov.uk/mda/mdawebsitev2.nsf/webvwRegulatoryPublications/F23BD16E4C0BC2ED00256A8F0035026A?OPEN

The Consolidated UK Medical Device Regulations (IS 2002 No.618): http://www.legislation.hmso.gov.uk/si/si2002/20020618.htm

 

FDA QUICK LINKS

http://www.fda.gov/cdrh/reglistpage.html (Device listing + Establishment Registration + etc)

Forms