Transport and storage validation proves that the device survives the real world between the factory door and the point of use. Regulation (EU) 2017/745 Annex I Section 11.7 obliges manufacturers to design and package devices so that their characteristics and performance during their intended use are not adversely affected during transport and storage, taking account of the instructions and information provided by the manufacturer. The evidence that this obligation is met lives in Annex II Section 6 of the technical documentation and typically consists of a distribution simulation test programme, temperature and humidity excursion testing, sterile barrier integrity after distribution stress, and a cross-reference to the stability and sterilisation workstreams. Industry normally runs this programme using recognised distribution simulation schemes such as the ISTA series or ASTM D4169, which the MDR does not mandate by name but which Notified Bodies recognise as state of the art.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • MDR Annex I Section 11.7 of Regulation (EU) 2017/745 requires devices to be designed and packaged so that transport and storage do not adversely affect performance, under the conditions the manufacturer specifies.
  • The evidence sits in Annex II Section 6 of the technical documentation and cross-references from the Annex I Section 11.7 line of the GSPR checklist.
  • A complete programme covers four areas: distribution simulation (vibration, shock, drop, compression), temperature and humidity excursion, sterile barrier integrity after distribution stress, and functional performance after distribution stress.
  • ISTA procedures and ASTM D4169 are commonly used as recognised distribution simulation schemes. Neither is mandated by the MDR. Both are recognised by Notified Bodies as reasonable state of the art when applied with justification.
  • Transport and storage validation is not a standalone island. It joins the sterilisation dossier and the stability dossier at the sterile barrier, and it joins the risk file at each failure mode.

The moment it becomes real

A startup ships the first commercial batch of a Class IIa device across the EU. The product arrives at a distributor in southern Spain in August. The carton sat on a tarmac for an afternoon. The device inside is the same device the Notified Body reviewed. The conditions it just travelled through were not. The first complaint lands a week later: calibration out of spec on units that passed every factory test.

The team discovers, during the root cause investigation, that the transport and storage validation section of the technical file contains one climate-chamber report at twenty-five degrees and sixty percent humidity, no vibration testing, no temperature excursion testing, and no distribution simulation. The label specified storage between fifteen and twenty-five degrees. Nobody had tested what happens when the real distribution chain blows past that number for six hours. The answer turned out to be: the device stops meeting its specification.

This is the problem Annex I Section 11.7 of the MDR exists to prevent, and it is the problem transport and storage validation evidence is designed to close.

What the MDR actually says

The General Safety and Performance Requirements in Annex I of Regulation (EU) 2017/745 are split into chapters. Chapter II covers requirements regarding design and manufacture. Section 11 is the cluster on infection and microbial contamination and on the conditions under which devices are supplied. Section 11.7 sets out the obligation for transport and storage: devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, taking account of the instructions and information provided by the manufacturer.

That is the obligation. The manufacturer specifies the transport and storage conditions on the label and in the instructions for use. The manufacturer is then responsible for proving that, under those specified conditions, the device still performs as intended when it arrives at the user.

Section 11.4 is the adjacent obligation for devices delivered in a sterile state: the sterile pack must maintain sterility through the declared storage and transport conditions until the protective packaging is damaged or opened. For sterile devices, Sections 11.4 and 11.7 are read together, and the transport and storage validation evidence must address both sterility and performance.

Annex II of the MDR specifies the structure of the technical documentation. Section 6 is the pre-clinical and clinical evidence section. Transport and storage validation evidence lives inside Section 6, cross-referenced from the Annex I Section 11.7 line of the GSPR checklist that sits in Annex II Section 4.

The four pillars of a complete programme

Transport and storage validation is not one test. It is a programme built around four questions.

Distribution simulation. Can the packaged device survive the mechanical stresses of a real distribution chain? This is vibration, shock, drop, compression, and stacking. The stresses are applied in a laboratory using profiles that represent a defined distribution scenario, for example small parcel carrier shipment or palletised truck transport. The industry standard reference schemes are the ISTA procedures published by the International Safe Transit Association and ASTM D4169, the standard practice for performance testing of shipping containers and systems. Neither scheme is mandated by the MDR. Both are recognised by Notified Bodies as reasonable state of the art when the manufacturer chooses the scheme that matches the actual distribution chain and justifies the choice in the protocol.

Temperature and humidity excursion. Can the device tolerate excursions outside the labelled storage range that are plausible in the real distribution chain? A label that says "store between two and eight degrees" meets an airport cold chain that sometimes fails. A label that says "store below thirty degrees" meets a truck on an Italian motorway in August that does not. Excursion testing exposes the device to defined temperature and humidity profiles, including spikes that exceed the label limits by realistic margins, and then tests whether the device still meets its acceptance criteria.

Sterile barrier integrity after distribution stress. For sterile devices, the packaging integrity testing that sits in the stability dossier must also be run after the device has been through distribution simulation. A sterile barrier system that survives ageing in a still climate chamber but has never been vibrated, dropped, or compressed has not been qualified for the actual field condition.

Functional performance after distribution stress. Packaging integrity alone is not enough. The device inside the packaging must still meet its design specification after the distribution simulation and excursion testing. Functional testing after stress closes the loop on the Annex I Section 11.7 obligation, because it is the performance of the device during its intended use that the regulation protects.

A transport and storage validation programme that addresses all four pillars is defensible. One that addresses fewer is not.

The ISTA and ASTM D4169 point, said correctly

A word on the distribution simulation schemes, because this is where posts and whitepapers commonly overstate the position. The MDR does not require ISTA. The MDR does not require ASTM D4169. The MDR requires evidence that transport and storage do not adversely affect performance. ISTA and ASTM D4169 are widely used recognised schemes that Notified Bodies accept as a reasonable basis for distribution simulation when the manufacturer has justified that the chosen scheme and level represents the real distribution chain of the device.

The justification matters. ASTM D4169 has multiple distribution cycles and multiple assurance levels. ISTA has several procedure series, from basic integrity tests to performance tests that simulate specific distribution profiles. Picking a scheme without stating why that scheme matches the device's real logistics path is a gap a reviewer will notice. The correct structure is: describe the actual distribution chain, choose the scheme and level that represents it, and write that rationale into the protocol before the first sample is tested.

Worked example: a Class IIa sterile single-use device

A startup manufactures a Class IIa sterile single-use device in Austria, distributes to hospitals across the EU through a mix of refrigerated and ambient road transport, and has declared a two-year shelf life with storage between five and thirty degrees Celsius. The transport and storage validation programme that lands cleanly with a Notified Body looks approximately like this.

The protocol opens with a characterisation of the distribution chain: country coverage, transport modes, typical and worst-case transit times, known climate exposures in the destinations, and the packaging configuration from primary sterile pouch through secondary carton to tertiary shipping unit.

The distribution simulation section selects an ASTM D4169 distribution cycle appropriate to mixed truck distribution in Europe, justifies the assurance level based on the fragility of the device, and specifies vibration, random shock, rotational drop, compression, and low-pressure tests in the documented sequence.

The temperature and humidity excursion section defines a profile that includes the labelled range, realistic spikes above and below, and a documented worst-case scenario derived from recorded distribution data. The profile specifies exposure duration, ramp rates, and the timepoints at which samples are removed for testing.

The test sample strategy has the device going through sterilisation first, then ageing, then distribution simulation, then excursion, then final testing. That sequence matches the condition of the device the moment before it reaches the user, and that is the condition the evidence must cover. Sampling sizes are justified against the acceptance criteria.

The acceptance criteria section lists, for each test, the packaging integrity criteria, the sterile barrier integrity criteria, the device functional criteria, and the visual inspection criteria. Each criterion traces back to a specific line in the design specification and to a specific failure mode in the risk file.

The report concludes with a pass or fail statement for each criterion, a summary of observations, and a cross-reference to the relevant Annex I lines in the GSPR checklist and to the stability dossier and sterilisation validation dossier. The whole package is version-controlled under EN ISO 13485:2016+A11:2021 and filed in Annex II Section 6.

A file with this structure answers the question the reviewer will ask. A file without it does not.

A validation plan template that fits on one page

The structure that consistently survives Notified Body review:

  1. Scope and rationale. What device, what packaging configuration, what distribution chain, what labelled storage conditions.
  2. Failure modes addressed. The specific failure modes from the risk file that transport and storage could trigger, and why each is in scope.
  3. Test sample condition. Sterilised, aged, or both. Justified against the actual field condition.
  4. Distribution simulation protocol. Scheme chosen, level chosen, test sequence, acceptance criteria. Justification for the scheme and level.
  5. Temperature and humidity excursion protocol. Profile, duration, ramp rates, sample points, acceptance criteria.
  6. Sterile barrier integrity testing after stress. Methods, acceptance criteria, sample sizes.
  7. Device functional testing after stress. Methods, acceptance criteria, sample sizes, traceability to the design specification.
  8. Reporting and cross-references. Pass and fail conclusions, cross-reference to GSPR checklist line for Annex I Section 11.7, cross-reference to stability and sterilisation dossiers.
  9. Ownership and change control. Who owns the document, how changes to the distribution chain or packaging trigger revalidation.

Any protocol that covers these nine points is defensible. Any protocol that skips one of them has a gap a reviewer will find.

Reality Check — Where do you stand?

  1. Does your technical file contain a transport and storage validation report that cross-references from the Annex I Section 11.7 line of your GSPR checklist?
  2. Is your distribution simulation protocol based on a recognised scheme such as ISTA or ASTM D4169, with the scheme and level justified against your actual distribution chain?
  3. Does your temperature and humidity excursion testing exceed the labelled storage limits by realistic margins drawn from actual distribution data?
  4. Were the samples used for transport and storage validation sterilised and aged before being stressed, matching the condition the device is in when it reaches the user?
  5. Does your programme test both sterile barrier integrity and device functional performance after distribution and excursion stress, or only one of them?
  6. If your distribution chain changes — new country, new carrier, new packaging — is there a documented trigger for revalidation?
  7. Does your protocol state the failure modes from the risk file that transport and storage could credibly activate, and does each test trace to one of those failure modes?

Frequently Asked Questions

Which MDR section covers transport and storage validation? Annex I Section 11.7 of Regulation (EU) 2017/745 requires devices to be designed, manufactured and packaged so that their characteristics and performance during intended use are not adversely affected during transport and storage, taking account of the manufacturer's instructions and information. For sterile devices, Section 11.4 is read together with 11.7 to cover sterility maintenance.

Does the MDR require ISTA or ASTM D4169 testing? No. The MDR requires evidence that transport and storage do not adversely affect performance. It does not name a specific distribution simulation scheme. ISTA procedures and ASTM D4169 are widely recognised schemes that Notified Bodies accept as reasonable state of the art when the manufacturer justifies that the chosen scheme and level represents the device's real distribution chain.

Where does transport and storage validation evidence sit in the technical file? In Annex II Section 6, the pre-clinical and clinical evidence section. It is cross-referenced from the Annex I Section 11.7 line of the GSPR checklist in Annex II Section 4, and it cross-references the stability and sterilisation validation workstreams for sterile devices.

Do samples need to be sterilised and aged before distribution simulation? Yes, for sterile devices with a declared shelf life. The condition the device is in when it reaches the user is sterilised, aged, and distributed. Testing on unsterilised or unaged samples does not match the field condition and leaves a defensible reviewer finding. See the shelf life and stability testing documentation post for the ageing side of the question.

Is packaging integrity testing enough to satisfy Section 11.7? No. Annex I Section 11.7 is about the characteristics and performance of the device during intended use, not only the packaging. Packaging integrity confirms sterility is maintained. Functional testing after distribution and excursion stress confirms the device inside the packaging still meets its design specification. Both layers belong in the file.

How are temperature excursion profiles chosen? From real distribution data, not from a template. The manufacturer characterises the actual distribution chain, identifies realistic worst-case excursions above and below the labelled range, and writes a profile that exposes the device to those conditions with appropriate margin. Data loggers on real shipments are the normal source.

When does transport and storage validation need to be repeated? When something in the distribution chain or the packaging changes in a way that could invalidate the original rationale. A new country, a new carrier mode, a new primary or secondary packaging configuration, or a material change to the device all trigger the question. A documented change-control trigger in the validation plan avoids the situation where the change happens silently and the file falls out of date.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Annex I Section 11.7 (transport and storage), Annex I Section 11.4 (sterile pack shelf life), Annex II Section 6 (pre-clinical and clinical evidence), and Article 10 (general obligations of manufacturers). Official Journal L 117, 5.5.2017.
  2. EN ISO 13485:2016 + A11:2021 — Medical devices — Quality management systems — Requirements for regulatory purposes.
  3. ISTA (International Safe Transit Association) procedures — widely used distribution simulation schemes, not mandated by MDR, recognised as state of the art when justified.
  4. ASTM D4169 — Standard Practice for Performance Testing of Shipping Containers and Systems, widely used distribution simulation standard, not mandated by MDR, recognised as state of the art when justified.

This post is part of the Technical Documentation & Labeling cluster in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. Tibor has reviewed transport and storage validation dossiers from both sides of the Notified Body table. Where the protocol names the actual distribution chain and chooses a recognised simulation scheme with a written rationale, first audits go smoothly. Where the chosen scheme is a template copy and the temperature profile is a guess, they do not.