When an inspector walks into your warehouse or pharmacy, one of the first things they check is how you handle the product from the moment it arrives until you hand it over. Regulation (EU) 2017/745 doesn't overlook this: article 14.3 states that, while the product is under your responsibility, you must ensure the storage and transport conditions set by the manufacturer are met.
This isn't a made-up obligation: it makes sense. If you store a clinical thermometer where you shouldn't, it may stop working properly. If an orthosis becomes deformed because the manufacturer's instructions weren't followed, it's no longer suitable for the patient. The MDR puts this in black and white, and it's down to the distributor to prove they've complied.
Who Does This Apply To?
According to article 2, point 34, of the MDR, a distributor is anyone in the supply chain other than the manufacturer or importer. This includes pharmacies, orthopaedic shops, opticians, and any small business selling medical devices to someone other than the end user.
If you're a manufacturer or importer, this section of article 14 doesn't apply to you: you have your own obligations under article 10 and article 13. But if you sell from a warehouse or counter a product that comes from elsewhere, article 14.3 applies to you.
Where Do Storage Conditions Come From?
Storage and transport conditions are set by the manufacturer, not you. You have to comply with them. They appear on the product label and, in more detail, in the instructions for use that must accompany the product according to Annex I, section 23.2, of the MDR.
This information includes the expiry date expressed at minimum in year and month, specific storage or handling conditions, and if the product is sterile, an indication of this and the sterilisation method. Also the batch or serial number and, where applicable, the UDI carrier.
That's why it's so important that, when you receive an order, you check that this documentation comes with the product. Article 14.2 already requires you to verify that the product bears the CE marking, that it has the EU declaration of conformity and that it is accompanied by the manufacturer's information in the required language.
Which Date Takes Precedence: Expiry or Manufacturing Date?
The label must carry the expiry date expressed at minimum in year and month. If there is no expiry date, then the manufacturing date must appear. In practice, for most products on your shelf, the expiry date is what matters.
This has a direct consequence: if a product exceeds its expiry date, you cannot continue to market it. It no longer meets its specifications. Article 14.4 requires you to notify the manufacturer if you have already sold it and believe it is not compliant.
Why Opening a Sterile Package Changes Everything?
Article 16.2 of the MDR states something that is sometimes overlooked: opening, damaging or deteriorating the packaging that maintains the sterility of a product alters its original condition. This means that if you open the blister of a sterile product to show it, to count the units or for any other reason, that product can no longer be sold as sterile.
It's not about you doing something wrong: it's that the product has changed condition and that has consequences. The manufacturer has validated that the product arrives sterile at the point of use; if you open the packaging, that guarantee disappears.
What Documentation Must You Have?
There is no specific document that says "storage conditions met". What the inspector wants to see is that you know the conditions the manufacturer has set and that you have followed them.
This can be demonstrated in several ways: with temperature records if the product requires it, with checks on receipt of the order, with staff training. There is no mandatory template or sampling percentage defined by the standard. It's about being able to explain what you did and why.
If you have received a product in poor condition or with sterile packaging compromised, this must be documented and reported to the manufacturer under article 14.4. If you believe the product presents a serious risk, you must also notify the competent authority.
Quick Questions
Can an inspector ask me for temperature records even if the product is not cold chain?
If the manufacturer has indicated specific temperature conditions on the label, yes. Article 14.3 requires you to meet those conditions. A temperature record proves you have done so.
Can I sell a product that has exceeded its expiry date but is in good condition?
No. The expiry date marks the point until which the manufacturer guarantees the product meets its specifications. After that date, you cannot market it.
What do I do if when receiving an order the sterile packaging is open or damaged?
Do not put it on sale. Document it, report it to the manufacturer and, if you consider it necessary given the risk it may pose, also notify the competent authority.
Does article 14.3 also apply to class I products?
Yes. Storage and transport conditions apply to any medical device while it is under the distributor's responsibility, regardless of class.
What to Do This Week
Review your latest medical device orders. Check that each product you have in stock bears its legible label with storage conditions and expiry date. If you find anything out of date or with sterile packaging compromised, separate it, document it and contact your supplier.
If you don't have any records of how you receive and store products, this week is a good time to start a simple one. It doesn't need to be complex: it's enough to record that you have checked what the manufacturer required and that it has been met.
To review what you need to check when a product arrives, you can read our article on CE marking on medical devices and how to request documentation from a supplier you don't fully trust in the article on how to request documentation from your supplier.
The obligation is yours while the product is in your possession. Proving you have met it is what counts when someone asks.