Is your CE Marking up to scratch? When you consider the technological changes that have taken place in the last ten years, it is hardly surprising that revisions to a fundamental standard for medical devices has left many manufacturers with serious issues of non-compliance.
Although your medical product may have been originally designed to be compliant with all relevant standards and guidelines in its original form, the CE marking could now be invalid because of a thorough revision of IEC 60601-1 which replaces the previous version, IEC 60601-1:1988 and its associated amendments. IEC 60601 refers to the series of technical standards for the safety and reliability of medical electrical equipment.
IEC60601-1 Third edition (2005-12) and Amendment 1 (2012) is now in force in the EU as of 1st June 2012, and is now also required by the FDA as of June 30th 2013. All medical devices on the market are required to be assessed and compliant with this if they choose to use this standard to demonstrate compliance with the MDD in Europe.
Triteq’s extensive experience in the design and development of medical devices and knowledge of the 3rd Edition of IEC60601-1 has meant that we are constantly approached by medical device manufacturers facing problems with CE marking. They are commissioning Triteq to work with them to update their product designs and documentation to bring 2nd Edition CE marked devices in line with current requirements. The 3rd edition incorporates fundamental changes from the 2nd edition and many manufacturers are finding these a challenge to demonstrate compliance. The 3rd edition varies in a number of key respects, primarily that there is a requirement to produce a risk management file and demonstrate product conformance to ISO14971 which is the ISO Standard for Application of Risk Management to Medical Devices. In addition there is a requirement to demonstrate essential performance of the device.
As a result manufacturers are finding that their CE marks are being revoked because they are now non-compliant.The majority of failures that are causing difficulties are due to non-compliance with Clause 14 relating to PEMS (Programmable, electrical, medical systems). The most common failure in this section relate to the requirement in section 14.4 Note 2. “NOTE 2 IEC 62304  defines general requirements for additional PROCESSES and activities specific to software development.”
Because of the long market life expectancy of medical products, many products still being sold were designed over ten years ago. Cosmetic changes will have taken place over the years and features added, but the core designs usually remain with minimal alterations.
The requirement for IEC62304 compliance would most likely have been alien to medical device designers at the time the products were designed. With products like this it becomes a major task to implement design processes and document old non-standard embedded code.
In many cases there is little or no code documentation other than a brief product specification and comments in the code itself. This is not acceptable and non-compliant. Back generation of code documentation, software risk analysis and architectures can be a laborious and costly process, unless you use an experienced company such as Triteq to identify what is required and implement the most efficient and effective procedure to generate the missing documentation.
Efficient streamlined processes are also required for future generation of code in order to maintain compliance with the standard. Developing and implementing these processes requires expertise and in-depth knowledge.
Triteq excel in this field and have developed an enviable reputation for resolving issues for manufacturers facing this type of situation. Ken Hall, Managing Director of Triteq Innovations is an expert in this field and has guided many companies through the changes they need to make to ensure compliance.