The first PHC products to be awarded MDD certification in 2011 were: the MCO-19AIC CO2 incubator with rapid H2O2 vapour decontamination option; the MBR-305GR blood bank refrigerator; and the MDF-U74V ultra-low temperature freezer. Since then, many more PHC products have also been certified, including:
As medical technology advances, the need for incubators and refrigerators for cultivation or storage of cells and tissues for human use is expected to grow further. PHC already provides a wide range of certified products for this sector, but invests continually and significantly to stay ahead of market and customers’ needs.
Complying with progress Medical device certification
PHC products are used by a growing number of customers for the preservation or cultivation of human cells, tissues and blood components, and selected products are classified as medical devices in this context, according to the European Union’s (EU) Medical Device Directive (MDD). PHC was one of the first major international companies to be awarded certification in compliance with the MDD for a wide range of incubation and refrigeration products in 2011. Since then, it has continued with commitment to certification of key products and its quality systems to ensure that PHC products meet all current and future regulatory requirements.
The EU’s MDD was established in the 1990s to ensure that medical devices of all kinds are safe, perform effectively and are designed, manufactured, tested and marketed according to harmonised methods and conditions. The stringent European standards are acknowledged globally, although other regions have their own specific regulations for medical device development and production.
The legislation comprises of three relevant Directives:
- the Active Implantable Medical Device (AIMD) Directive - 90/385/EEC;
- the Medical Device Directive (MDD) - 93/42/EEC; and
- the In Vitro Diagnostic Device Directive (IVD) - 98/79/EC.
The Directives 90/385/EEC (AIMD) and 93/42/EC (MDD) were changed by Directive 2007/47/EC of the European Parliament and the Council of 5th September 2007. These changes applied from 21st March 2010.
In addition, medical devices and accessories are classified into one of four classes: I, IIa, IIb and III. This classification is based on the specific devices’ invasiveness; duration of continuous contact with the body; the nature of the tissue contact and whether the device is non-active or active. In general:
- Class I includes devices with low risk, such as external patient support products.
- Class IIa/b covers devices with medium risk, such as electro-medical devices.
- Class III comprises devices with high risk, such as cardiovascular catheters.
PHC is certified to manufacture blood bank refrigerators, freezers and incubators as Class IIa medical devices, in line with Directives 93/42/EEC and 2007/47/EC, for the following medical purposes:
- Blood bank refrigerators - Storage of blood.
- Freezers - Storage of cells, organs, DNA or plasma.
- Incubators - Culture of cell tissues, organs or embryos.
Compliance with the Directive and certification for Class IIa devices is assessed and granted by a specific, EU-designated, Notified Body – For Panasonic’s products, this authority is the TÜV-Süd, a leading technical service organisation, with headquarters in Munich, Germany.
Every step in the process of design, manufacture and testing is subject to a multitude of complex and specific rules and regulations when applying for medical device status. Declaring a relevant product as a medical device is a significant scientific, engineering and business undertaking. It is very different from developing a ‘non-medical’ electronic product.
Obtaining MDD certification shows not only that PHC products are designed and manufactured to exceptionally high standards, but also that PHC is deeply committed to serving scientific professionals in the medical field and ultimately, helping patients.
Achieving certification requires compliance that extends way beyond product function. It demands that Panasonic provides a consistent and effective quality management system, technical documentation, essential product requirements, information about harmonised standards and medical device regulations, risk analysis, post-marketing surveillance, reporting under the vigilance system, and a retention system for certain critical documentation. Certified medical devices must display a CE mark that indicates conformance with the MDD.
Acquiring MDD approval is definitely a lengthy and intricate process. PHC had to submit extensive information for certification and assessment, including technical documentation, test results and data on quality systems. A large cross-functional team was involved, including development, engineering, regulatory and quality experts. In applying for EU MDD certification, PHC also upgraded compliance of its quality systems to the highest and latest global standards for medical devices according to ISO (the International Organisation for Standardization) - ISO13485.