SmartFreezer®: Meeting the Medical Device Directive for Safe Sample Management
Medical devices are an essential component of healthcare, and they have significantly improved the quality of life for many patients worldwide. These devices may be categorised by their intended use and range from simple non-invasive items to fully implantable devices. The Medical Device Directive EU 2017/745 (MDD) is a regulation that sets out the essential requirements that medical devices must meet before they can be placed on the market. In this article, we will explore the importance of the MDD, the rigorous steps taken to achieve it, and what it means for your assurance.
What is the Medical Device Directive EU 2017/745?
The Medical Device Directive EU 2017/745 is a regulation that outlines the essential requirements that medical devices must meet before they can be placed on the market. The MDD applies to all medical devices that are placed on the market within the European Union (EU).
The MDD regulates medical devices in three categories, which are based on the level of risk that the device poses to the patient. These categories are:
- Class I – Devices that present a low risk to the patient. Examples include thermometers and bandages.
- Class IIa and IIb – Devices that present a medium to high risk to the patient. Examples include freezers for storing blood or tissue.
- Class III – Devices that present the highest risk to the patient. Examples include implantable devices such as pacemakers, artificial heart valves and heart-lung machines.
Why is the MDD important?
The MDD is essential because it ensures that medical devices are safe and effective before they are placed on the market. It also provides a framework for manufacturers to design and develop medical devices that meet the essential requirements. Compliance with the MDD is mandatory for all medical device manufacturers who wish to sell their products within the EU.
Obtaining MDD Accreditation
To obtain the MDD, medical device manufacturers must follow a set of procedures outlined in the regulation. These procedures include:
- Conformity assessment – Manufacturers must conduct a conformity assessment to ensure that their medical device meets the essential requirements set out in the MDD.
- Technical documentation – Manufacturers must compile technical documentation that demonstrates that their medical device meets the essential requirements set out in the MDD.
- CE marking – Manufacturers must affix the CE marking to their medical device to indicate that it meets the essential requirements set out in the MDD.
- Declaration of conformity – Manufacturers must provide a declaration of conformity to confirm that their medical device meets the essential requirements set out in the MDD.
A fully automated cryogenic freezer, SmartFreezer EVO provides a safe, robotic solution for the storage and retrieval of biological sample vials in liquid nitrogen (vapour phase). Eliminating the risks associated with the storing and retrieval of these vials, and coupled with Medical Device Directive compliance, users can have complete peace of mind that they are working with the best and safest cryo technology available today.
With storage for 19,000+ vials and no operator exposure to liquid nitrogen, discover the SmartFreezer EVO and how it can play an essential role in your laboratory.
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