Is testing mandatory for unannounced audits?
For quality management related certificates, testing is not mandatory. However, testing may occur if the unannounced audit team has reasonable doubts about the conformity of the device type(s). The performed test(s) may include additional testing in line with Section 4 of Annex III of the European Commission Recommendation 2013/473/EU.
For product related certificates where the manufacturer has applied for a design dossier examination or for a type examination (product assessment), Notified Bodies should perform testing in line with Section 4 of Annex III of the European Commission Recommendation 2013/473/EU.
When testing a product sample, would it be sufficient that testing is done on-site with the TÜV SÜD auditor as a witness?
Yes, on-site testing with the TÜV SÜD auditor as a witness might be sufficient if tests can be performed on-site.
Other options include the testing of samples by our laboratory or by qualified personnel under one of the following:
- Under TÜV SÜD observation on TÜV SÜD premises
- On the manufacturer’s premises
- On the premises of the manufacturer’s critical supplier
- In qualified external laboratories
If an auditor decides to take an expensive product for off-site testing, will the product be returned in its original condition? Will we be reimbursed for the product?
If it is possible to perform tests on raw materials, intermediates, components or unfinished products, these tests will take place instead of destructive tests on final devices. The device acquisition and its testing will be financed by the manufacturer.
Please refer to the TÜV SÜD Testing and Certification Regulations, Module B1 Special Regulations for product testing and certification.
What happens if the proposed samples for testing are urgently needed to avoid a back order situation?
If sampling at the manufacturer’s premises is not feasible, Notified Bodies should take samples from the market if necessary (with support by the competent authorities), or should perform testing on a device installed at a customer location. If it is possible to perform tests on raw materials, intermediates, components or unfinished products, these tests will take place instead of destructive tests on final devices.
What criteria do Notified Bodies have for selecting the products that will be sampled?
Notified Bodies may select products which have a high likelihood of nonconformity. Other reasons may include:
- Media reports and news about malfunctions
- High risk devices
- Noncompliant products
- Information from the market based on malfunctions of similar products
- Information or inquiries from the authorities
- High rate of device noncompliance
How will sampled products be tested?
Testing of device conformity will be done in accordance to ANNEX III Section 4 of the European Commission’s Recommendation 2013/473/EU, with the main focus on the safety and performance of the device. Possible tests include:
- Microbiological safety testing
- Mechanical safety testing
- Packaging testing
- Performance testing
- Electrical safety testing
- Functional safety testing
- EMC testing
Will planned testing be duplicating design verification testing or other testing?
Yes, partly, because the products will be tested against the specification of the manufacturer, which are part of the Technical Documentation. The goal of the testing is compliance testing towards the manufacturer's specification and not the verification of product design.
Will the manufacturer's product experts be engaged when the Notified Body is planning product tests?
No, because the products will be tested against the specification of the manufacturer, which are part of the Technical Documentation. When testing is performed on the manufacturer’s premises, the manufacturer will use its own personnel and laboratory test equipment while the personnel from TÜV SÜD will supervise the tests.
How will the manufacturer be involved in the unannounced audit during the testing of components?
When testing components on the manufacturer’s premises, the manufacturer will use its own personnel and laboratory test equipment while the personnel from TÜV SÜD will supervise the tests.
Can the manufacturer’s products, subassemblies or components be sampled at their supplier’s premises?
The European Commission Recommendation requires performing tests at the premises of critical subcontractors or crucial suppliers. Testing could even be performed on devices installed at a customer location. But samples may only be taken at the site of the supplier with the manufacturer’s consent.
What will determine whether a product will be tested on-site or off-site?
If products cannot be tested on-site during audit or if the product cannot be tested on-site for technical reasons, the following options are available:
- If samples are available and can easily be shipped to our laboratories and tested in our laboratories, the device will be sampled during an audit for later testing.
- If samples are available but difficult to be shipped out or if they are difficult to be tested in our laboratories, the tests will be performed on the selected device at the manufacturer’s, operator’s (such as a hospital), or critical supplier’s premises as arranged by the manufacturer.
- If there is no certified device type manufactured at the time of the unannounced audit. Test samples will be bought on the market and shipped to our laboratories.
How will testing be conducted on products that do not have a finalised sample?
If sampling at the manufacturer’s premises is not possible, Notified Bodies should take samples from the market, if necessary with support by the competent authorities, or should perform testing on a device installed at a customer location.
If it is possible to perform tests on raw materials, intermediates, components or unfinished products, these tests will take place instead of destructive tests on final devices.
What are the implications if test results are not as expected? What is the process for resolving this?
The results will be evaluated together with the manufacturer regarding criticality and risk. If deemed necessary, further testing will be required to confirm the deviations. Based on a root-cause analysis requested from the manufacturer, further corrections and corrective actions will be initiated. If the test results play an important role in the safety and performance of the device, a recommendation of suspension of its certification can follow if the results deviate negatively when compared to the manufacturer’s specification and essential requirements.
What information do I have to provide for product testing planning?
Manufacturers are asked to categorise 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
What information do I have to provide for product testing?
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
How is the number of high risk devices to be sampled for testing determined?
A: The number of device types to be sampled for testing depends on the number of different device types certified (refer to table below). The actual models (product codes) sampled are representative of products which may have a high likelihood of nonconformity.
|Total number of manufacturer's device types||Number of device types to be sampled for testing |
| 4 to 99||3|
| 100 to 100|| 4|
| 200 to 299|| 5|
| 300 to 399|| 6|
| etc.|| |
What should manufacturers take note of if samples have to be shipped to our laboratories?
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.