Our professional blood bank refrigerators are the optimal choice for the safe storage of blood, due to their exceptional temperature uniformity and reliable technology.
Our blood storage refrigerators ensure that the essential and lifesaving blood is well protected. Visibility within the blood refrigerator is also a vital element that we’ve added to our devices, as the ability to monitor temperature and appearance of stored blood will further ensure that the quality, integrity and standard of your blood bags will remain high at all times. They adhere to the Medical Device Directive and will soon have Medical Device Regulatory certificates.
The Medical Device Directive Standard and what it means for you
The Medical Device Directive was introduced in 1993, to ensure that there was a sufficient harmonisation of safety laws for medical devices.
The Medical Device Directive was considered to be a new approach to having standardised safety across the medical device industry, and consequently in order for a manufacturer to legally be able to enter a medical device onto the European market, the specific requirements of the Directive had to be met.
Any manufacturer producing medical devices has a presumption of conformity to the Medical Device Directive if they have complied with the specific harmonised standards laid out in the Directive and must display a CE mark to provide evidence of this compliance.
Our blood refrigerators already successfully adhere to the Medical Device Directive, due to their reliable technology and the strict adherence to the requirements stipulated within the Directive, meaning that you’ll be safe in the knowledge that your blood storage refrigerator is a safe investment. Certificates issued in accordance with Directive 93/42/EEC will remain valid until 27 May 2024.
The new Medical Device Regulation (MDR) in 2021
The European Medical Device Regulatory was introduced to full EU member states in May 2021, to further ensure that development, production, and supply of medical devices within Europe is held to a high standard of safety, along with providing a further layer of uniformity across the EU.
The key changes within the Medical Device Regulation include more rigorous post-market surveillance, an increase in the accurate and stringent documentation required and a regular systematic clinical evaluation of medical devices.
As the Medical Device Regulatory certificate will replace the existing Medical Device Directive that we have in place for our blood bank refrigerators, we are currently in the process of obtaining this certification. Due to the pandemic, there has been a delay in medical device manufacturers being able to receive their approval. However, please be assured that this delay in no way diminishes the safety or performance of our products.
Any of our products, including our blood bank fridges and blood bank freezers, which already stringently comply with the original Medical Device Directive are already steadily moving along the process of receiving their Medical Device Regulation certification.