| |
 |
The Medical Device Directive 93/42 EEC as Amended by 2007/47 EC—Are you Ready?
Manufacturers must be in full compliance with the changes that apply to them by March 21, 2010.
Changes to the Directive include, but are not limited to:
- Re-Classification of some devices that impact the central circulatory system
- Record retention
- Increased emphasis on clinical data (required for all devices, regardless of EU classification)
- Software classification
- Conformity assessment options-class I manufacturers may choose Annex II
- More in depth review of technical documentation by Notified Bodies
- Usability/ergonomics per EN 62366
- Overlap with Machinery Directive 2006/42 EC
It is critical that each manufacturer review 2007/47 as well as related guidance documents to determine what changes are applicable and the impact of the changes. Reviews should be documented and with justification for those requirements deemed not applicable.
|
|
Industry Sites
FDA Center for Devices and Radiological Health:
www.fda.gov/cdrh/
ISO:
http://www.iso.org
SCC ( Standards Council of Canada):
http://www.scc.ca
TPD (Therapeutic Products Directorate):
http://www.hc-sc.gc.ca/dhp-mps/index_e.html
Listing of Competent authorities:
http://europa.eu.int/comm/enterprise/medical_devices/ca/list_ca.htm
EU Guidance Documents:
http://ec.europa.eu/enterprise/medical_devices/meddev/
AAMI (Association for the Advancement of Medical Instrumentation)
www.aami.org
CEN (European Commission for Standardization):
http://www.cen.eu
GHTF (Global Harmonization Task Force):
http://ghtf.org
SDRAN (San Diego Regulatory Affairs Network):
http://sdran.org
ASQ Biomedical Division:
http://asq.org/biomed/
|
|
 |
