Oxoid now displays the medical device CE mark on its entire range of medical products, showing compliance to the requirements of the in vitro diagnostic directive
Oxoid now displays the medical device CE mark on its entire range of medical products, showing compliance to the requirements of the in vitro diagnostic directive (IVDD) 98/79/EC.
Oxoid says it always aims to stay on the front foot when it comes to meeting international regulatory requirements.
Having prepared for this latest directive as far back as 1998, when Oxoid achieved BS EN46001:1997 registration, the company has now added the CE mark to its extensive range of clinical products.
The CE mark provides Oxoid customers with the assurance that a quality system is in place and that products meet the stringent safety and labelling requirements of the directive.
This has included the preparation of risk analysis files and the provision of new ten-language labels on Oxoid products.
A team of professionals within the Oxoid organisation has been responsible for driving this project forward.
Quality manager Richard Huggins comments, "As a global organisation, we are dedicated to meeting the many regulatory standards in force around the world.
"This latest European directive will undoubtedly improve the overall quality of the industry and will ensure that IVDD manufacturers are compliant with the necessary quality and safety standards". The IVD directive (98/79/EC), published in the Official Journal of European Communities in 1998, introduced the first legislative controls dealing with the safety, quality and performance of in vitro diagnostic medical devices.
The CE Mark is the customers' assurance of compliance with this directive.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the Competent Authority that will ensure that the requirements of the directive are met, thus maintaining that IVD products do not compromise the health and safety of patients and users.
