Design verification and accredited testing of medical devices

Denmark In Danish
Accredited testing and documentation ensure that your medical devices comply with MDR requirements - and reduce the risk of delays in the approval process.

Design verification is systematic documentation confirming that a medical product fulfills the specified requirements for function, safety, and performance throughout its expected lifespan. It is a central part of the technical documentation under the MDR (Medical Device Regulation) and a prerequisite for CE marking.

Insufficient or incomplete documentation is one of the most common causes of delays in dialogues with notified bodies and competent authorities. The Plastics Laboratory at the Danish Technological Institute assists manufacturers with accredited testing, method validation, and documentation that withstands regulatory scrutiny - the first time.

How can Danish Technological Institute help you?

The Plastics Laboratory at the Danish Technological Institute offers accredited testing and consultancy across the entire chain of design verification for medical devices:

Luer lock and small-bore connectors: Test for leakage, durability, and resistance to separation in accordance with the ISO 80369 series.
Syringe functionality: Test for glide force, break-loose force, leakage, and operating forces in accordance with ISO 7886-1 and the ISO 11040 series, among others.
Packaging peel-open strength: Documentation of controlled and functional opening according to standards such as ASTM F88/F88M.
Integrity of sterile barrier systems (CCI): Assessment of the packaging's protective function according to standards including ASTM F1929, ASTM F2096, and USP 671.
Coring and resealability: For needle-based systems, septa, and vials, testing is performed for coring - the risk that needle insertion punches out or releases material from the septum - and for resealability, i.e., whether the closure can reseal and maintain its function after repeated punctures. Testing is performed according to relevant parts of ISO 8871-5 and the ISO 11608 series, among others.
Fragment identification: Visual and materials science analysis of loose particles resulting from use or mechanical stress.
Legibility, labeling, and visual inspection: Assessment under controlled lighting conditions according to ISO 20417, among others, as part of stability studies or exploratory test programs.
Accelerated and real-time aging: Documentation of shelf life based on standards such as ASTM F1980 - a key requirement for the CE marking of sterile-packed medical devices. Accelerated aging allows for estimating the product's shelf life in a shorter timeframe. The results can often be used as a basis for an early market launch while real-time data is collected continuously. Real-time aging supplements the documentation of the product's actual declared shelf-life period and is typically a requirement for final approval.
Transit/transport simulation: Testing the resistance and durability of the product and its packaging under distribution conditions. The simulation documents that the product and packaging maintain functionality and integrity after the stresses they are expected to encounter during distribution and storage. By combining accelerated aging with real-time data and transport simulation, you build a comprehensive documentation package covering the product's entire lifecycle – from release to end use.
Test protocols and scientific rationales: Preparation or review of test plans tailored to your product and regulatory requirements.

Why is design verification critical under the MDR?

Under the MDR (Medical Device Regulation), manufacturers must document that their product complies with the general safety and performance requirements – not only upon release, but throughout the entire declared shelf-life period. This includes the product’s functionality, packaging integrity, and the protective properties of the sterile barrier system after transport, storage, and aging.

Deficiencies and observations raised by notified bodies regarding technical documentation are among the most common reasons why the approval process is delayed. A systematic and thorough design verification supported by accredited test results mitigates this risk and provides a stronger foundation in discussions with regulatory authorities.

The Danish Technological Institute is accredited by DANAK (accreditation number 300) in accordance with ISO/IEC 17025, ensuring that test results carry the evidential weight and credibility expected by notified bodies and authorities.

From test protocol to accredited report

Danish Technological Institute assists not only with the physical testing itself, but also with the technical considerations before and after the testing process. This may include:

Preparation or review of test protocols tailored to your product and regulatory requirements
Selection of relevant standards and test methods based on the product’s risk assessment and intended purpose
Scientific/technical justifications for the selection of test parameters and acceptance criteria
Accredited test reports with traceable documentation suitable for direct inclusion in the technical documentation under the MDR

Is your specific standard or test method not listed above? The Danish Technological Institute has extensive experience in developing customized testing and documentation programs tailored to your specific product and requirements.

Contact us regarding medical device testing

Would you like to discuss how testing and documentation can be structured for your specific product? Contact our specialist, Lise Dahl Andersen, for an initial discussion about your needs and the relevant standards.

FAQ

What is design verification of medical devices?

Design verification is the systematic documentation confirming that a medical product fulfills the specified requirements for function, safety, and performance. Under the MDR, design verification is a central part of the technical documentation that the manufacturer must submit to the notified body for CE marking.

Which tests are typically required for sterile-packed medical devices?

It depends on the product type, but typically includes container closure integrity (CCI) testing, peel-open strength, accelerated and real-time aging, and transport simulation. For products with connectors, syringes, or needle-based systems, functional tests according to relevant standards are also required.

What is the difference between accelerated aging and real-time aging?

Accelerated aging (e.g., in accordance with ASTM F1980) simulates long-term storage at elevated temperatures to estimate shelf life in a shorter period. Real-time aging involves storing the product under actual, real-world conditions for the entire duration of the declared shelf life. Both types of data are typically included in the overall documentation.

Can results from accelerated aging be used for CE marking?

In many cases, results from accelerated aging can be used as the basis for an early market launch while real-time data is collected in parallel. Final documentation typically requires that real-time data confirms the results obtained from accelerated aging.

What does it mean that the testing is accredited?

Accredited testing in accordance with ISO/IEC 17025 means that the laboratory has been assessed and approved by an independent national accreditation body – in this case, DANAK (accreditation number 300). This ensures traceable and internationally recognized test results that notified bodies and regulatory authorities can trust.

What is Container Closure Integrity (CCI)?

Container Closure Integrity (CCI) is documentation that a packaging system continues to protect the product as intended – such as maintaining sterility - following manufacturing, transport, and storage. CCI testing can be performed in accordance with standards including ASTM F1929, ASTM F2096, and USP 671.

Can Danish Technological Institute help prepare test protocols?

Yes. The Danish Technological Institute assists in preparing and reviewing test protocols, selecting relevant standards, and formulating scientific rationales for test parameters and acceptance criteria. This ensures that testing is aligned with your product and regulatory requirements from the outset.