New Dedicated Medical Directives Team
LRQA has reorganised the way it manages its medical device (MDD) and in vitro diagnostic (IVDD) directives business with the formation of a Medical Directives Team. This team, located in Coventry, comprises both technical and operational support staff and will be the point of contact for information and assistance for clients requiring services under MDD and IVDD Directives. The team is dedicated to providing an improved, streamlined service to all of its MDD and IVDD clients worldwide.
LRQA is designated as a Notified Body to provide Product Conformity assessment services under both the Medical Device Directive (93/42/EEC) and the In-Vitro Diagnostic Medical Device Directive (98/79/EC). Manufacturer’s placing products regulated by these Directives on the market in the EU need to demonstrate compliance by affixing the CE marking. The Directives use a risk based approach and classification systems to further identify the actions that Manufacturer’s need to perform prior to CE marking. LRQA performs certification for both Directives by assessment of manufacturer’s Quality Management Systems and review of the technical documentation demonstrating how products comply with the ‘essential requirements’ given in Annex I of both the MDD and IVDD.
LRQA is able to certify all medical devices through the quality assurance conformity routes of the MDD (Annexes II, V & VI).
For the IVDD, LRQA again has a full scope for all the product types listed in Annex II of the IVDD through the quality assurance conformity routes (Annexes IV & VII). These include the high risk List A products for HIV-1 & 2, HBV, HCV, HDV, HTLV-1 & 2 and blood grouping products (ABO, Rhesus & Anti-Kell) and the medium risk List B devices for Rubella, Toxoplasmosis, CMV, Chlamydia, tissue typing, blood grouping (anti-Duffy and anti-Kidd), PKU, PSA, evaluation of Trisomy 21 and self-diagnosis devices for the measurement of blood sugar. Additionally LRQA can certify self-test devices under Annex III of the IVDD.
Our Medical Directives Team can assist manufacturers to identify regulatory requirements and advise on the services that LRQA can provide.
For further information, please contact the Medical Directives Team:
by e-mail medicaldirectives@lrqa.com or by phone +44 (0)24 7688 2393.
Changes to the European Medical Devices Directive
The Medical Devices Directive 93/42/EEC has recently undergone review by the European Commission. Changes, which will come into force in March 2010, have been published in an amending Directive – 2007/47/EC.
LRQA has prepared a Customer Information Note that gives further details of this revision and will continue to provide information during the transition period as further guidance & interpretation is available.
Download Customer Information Notes in PDF form |
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