What to expect from product testing of high risk devices
Recommendation 2013/473/EU of the European Commission requires the performance of sample testing in the course of unannounced audits for high risk medical devices, which the Commission classifies as all products for which type examination or design dossier examination (product assessment) is performed as part of certification. Products for testing are selected under a sampling plan predefined by the Commission in line with the device type category in which the manufacturer classifies his product. To ensure smooth planning and performance of the unannounced audit, manufacturers are required to provide comprehensive information and documentation for the device types, their design and construction, suppliers, and tests, and are responsible for ensuring that the products selected by the audit team are available on site or at the test laboratory. This article explains the background and procedures involved.
Based on the European Commission recommendation 2013/473/EU, Notified Bodies including TÜV SÜD Product Service started last year to conduct unannounced audits (UAA) at medical device manufacturers that hold EC certificates. The recommendation requires not only unannounced visits to the manufacturer, but also the testing of medical devices for which a product assessment such as type examination or design dossier examination has been certified. TÜV SÜD Product Service has recently established the processes for this additional product testing.
Purpose of testing
The goal of testing is to examine the conformity of the device with legal obligations and design specifications. Product samples should be tested by the Notified Bodies according to predefined sampling criteria and testing procedures.
Selection of high risk devices for testing
Depending on the number of different device types certified, different device types are selected. The actual models (product codes) sampled are representative worst-case devices from each device type selected. Sampling plan according to EU recommendation 2013/473/EU:
Total number of manufacturer’s device types
Number of device types to be sampled for testing
4 to 99
100 to 199
200 to 299
300 to 399
The UAA testing sampling plan for device types considers relevant information on products which are frequently noncompliant or subject to critical vigilance notifications, or where nonconformities of the devices are suspected.
Definition of device type
A device type is defined by the maximum configuration, a list of components/subassemblies, and a description of how the models are constructed from the maximum configuration and list. All models included in the device type typically have in common their design, construction, parts, or assemblies essential to ensure conformity with applicable requirements. For the same device, there may be differences in defined device types that are dependent upon the same nature or type of compliance criteria applied (e.g. area of application [intracardiac catheter], application range [bone screws], safety, electromagnetic compatibility (EMC), performance, efficacy, etc.). If a product standard defines a device type in the context of a collateral standard, this definition prevails.
To achieve the purpose of testing, it is crucial that the devices are tested against the specification and final product-release criteria as established by the manufacturer and certified by TÜV SÜD Product Service during the product assessment. Varying test methods, test equipment, and test conditions can significantly influence the result of product testing. Such sources of deviations need to be reduced and controlled as far as possible.
Information to be provided for product testing planning
Manufacturers are asked to categorize their product portfolio of all CE-certified models into device types. A definition for each device type must be available and include the following information:
The complete range of models (product codes) included in the device type
The criteria applied to include this range of models in a device category
A description of how the models are constructed
A list of components
A list of subassemblies
Information on critical suppliers / outsourced processes, in particular testing
During the regular audit the audit team will select information about device categorization and all CE-marked product codes. TÜV SÜD Product Service will use these data for the planning of the unannounced audit and product testing. To ensure the success of an unannounced audit and, particularly, a smooth test flow, it is extremely important that these data are accurate and up to date. Otherwise performance of correct testing may prove impossible, causing additional costs for repeated testing and additional test samples.
Information about regular product testing at your suppliers is equally important. To ensure the Notified Body is kept up to date with ongoing information, appropriate communication channels and responsibilities must be established between manufacturer, suppliers, and TÜV SÜD Product Service.
Information to be provided for product testing
The products are tested against the specifications developed by the manufacturer. To ensure a correct testing procedure and reliable results, the following information and documentation must be provided by the manufacturer:
• Complete product specification(s) • Final batch testing report(s) of the selected samples • Test protocols and results from design verification and design validation (or type examination) • Test description and instructions, and related forms if applicable
Sampling and testing process
The audit team takes random test samples for the device types subject to product assessment.
Depending on whether the samples are available at the audit site, how difficult it is to ship the samples to a laboratory, or how difficult it is to perform the testing in external laboratories, various scenarios can be applied:
• Device is sampled at audit for later testing in the manufacturer’s own laboratory. • Device is sampled at audit for later testing in the laboratory of TÜV SÜD Product Service or a contract laboratory. • Device is sampled at the critical supplier for later testing. • Device is sampled at the customer (distributor) or user (healthcare facility) for later testing.
If it is possible to perform tests on raw materials, intermediates, components or unfinished products, these tests will be preferred instead of destructive tests on final devices to reduce the costs of test samples. Shipping of selected and sealed samples to the laboratories is the responsibility of the manufacturer. The samples must be shipped using the same qualified transportation (packaging and transport) as the shipment of finished goods to the customers. For international shipments a proforma invoice including a clear English product description and the statement “Samples without value. For testing only” must accompany the samples for customs clearance. If any seals are broken the sample must be rejected and returned to the manufacturer, and a new sample randomly selected for testing.
After testing the final test report is sent to the manufacturer. In case of positive test results no further actions are required. Where deviations are detected during testing, a root cause analysis is performed together with the manufacturer, and the criticality and risk associated with the deviation are evaluated. Suspension of the certificates for the affected device category may be indicated as a final consequence.