You have received an email or a call from your supplier: there is a medical device recall. You probably have a document in front of you with the product name, the batch numbers affected, and some instructions. What now?
Before doing anything, take a breath. This follows clear steps, and your main job is to act in an orderly fashion and document everything. Here we explain what obligations you have as a distributor, what falls to the manufacturer, and what records you need to have ready so that, if anyone asks, you can prove you took the appropriate action.
Recall or recovery? They are not the same thing
These two terms appear in the Regulation, and it is important to distinguish between them because your actions differ. A recall prevents a product that is already in the supply chain from continuing to be made available on the market. The product may be in your warehouse or in a customer's warehouse where it has not yet been used or delivered to a patient. Your goal is to stop it before it goes any further.
A recovery is when the product has already been delivered to the end user — a patient who takes crutches or contact lenses home — and needs to be asked to return them. Here things get more complicated because you need to locate specific individuals.
The manufacturer, under Article 10.12 of the MDR, is the one who decides which action applies and who must carry it out. Your obligation as a distributor is to cooperate with the instructions it gives, within your role in the supply chain.
What the manufacturer has to do
The manufacturer leads the corrective action. Under Article 10.12, when it detects that one of its products is not in conformity, it must immediately take the measures necessary to bring it into conformity, recall it, or recover it. It must also notify distributors of this.
If the action is due to a serious risk, the manufacturer must also notify the competent authorities of the Member States where it placed the product on the market. Unless there is urgency, it must inform the competent authority without undue delay and before taking the action, under Article 87.8.
This means the manufacturer must send you a formal communication containing at a minimum: which product is affected (name, reference, batch or serial numbers), what problem has been detected, what action is expected of you (removing stock, contacting customers, returning the product) and for how long. If that communication does not arrive or is incomplete, you may request it in writing.
Your obligations as a distributor
Your role is set out mainly in Article 14, paragraphs 4 and 5, of the MDR. You are not the one who decides on the action, but you do have specific tasks.
If you have already sold the product to other distributors or healthcare facilities, you must pass on the manufacturer's information without undue delay. They receive the same notice that you received.
If the product is in your possession, you must remove it from sale until the manufacturer clarifies the situation. You cannot put it back on the market on your own if you have received a recall notice.
If the product has already been delivered to the end user (a patient, a healthcare professional), the recovery is the manufacturer's responsibility, but it may ask for your help in tracing who received it. This is where your traceability records come into play.
If you detect that something is wrong, Article 14.4 obliges you to notify the manufacturer immediately, cooperate with the actions it determines, and, if there is a serious risk, also alert the competent authority in your autonomous community.
The records you need to act
This is not something you want to improvise when the call comes in. Article 14.5 and Article 25 of the MDR require you to keep a record of recalls and recoveries affecting your products, and to be able to identify to whom you supplied each product.
Specifically, you must be able to state to which economic operator (the next distributor or healthcare facility) you sold a product, and from whom you received it. This information must be available for at least 10 years (15 if it is an implantable product).
In other words: if the manufacturer asks you for data on the laboratories and clinics that were sold the product, you need to be able to produce it in minutes, not days. If you do not currently have that system in place, this is a good reason to set it up.
You do not need expensive software. A well-organised spreadsheet with columns for date, product, batch number, customer, and supplier can be a good starting point, as long as you keep it up to date.
What to do when the safety notice arrives
A safety notice is the formal communication the manufacturer sends to its customers to inform them of the corrective action. It usually includes a description of the problem, the affected products, usage instructions, and a contact.
When you receive it, here is what you should check now:
- Which product and which batches are affected. Locate the corresponding units in your stock.
- What the manufacturer is asking you to do exactly: return the product, quarantine it, inform your customers, wait for instructions. Follow its instructions to the letter.
- Who you need to notify among your customers. If you sold them that product, they need to know. Send them the safety notice or a summary with the instructions you have been given.
- What to record. Note the date you received the notice, who you informed, and which product it was. Keep a copy of the notice and of any communications you send.
Quick questions
Can I destroy the recalled product myself?
No, not without instruction from the manufacturer. If the product is defective or non-conforming, the manufacturer must indicate how to proceed with disposal so that it does not pose a risk. You do not decide on your own.
Do I need to notify the health authority even if the manufacturer has already done so?
If the manufacturer detected the problem and has informed the authorities, you normally do not need to duplicate the communication. However, if you have received complaints from patients or healthcare professionals about that same product, you must forward them to the manufacturer and, if there is a serious risk, also alert the competent authority (Article 14.5).
How much time do I have to act?
Immediately. The Regulation refers to communication "without undue delay". The sooner you remove the product from the market and notify your customers, the lower the risk to users.
Can the autonomous community fine me for not having records in order?
Sanctions are decided by the competent authority on a case-by-case basis, according to the severity of the infringement. What we can tell you is that lacking traceability or failing to cooperate in a safety corrective action are conduct that Article 14 of the MDR lists as obligations. Keeping your records in order allows you to demonstrate that you acted diligently.
What to do this week
- Check whether you have any pending recall notices or safety notices from a supplier that you have not yet processed. If so, act today.
- Locate in your warehouse the products affected by pending notices and remove them from sale.
- Verify that you can identify to whom you supplied each product over the last 10 years (or 15 if there are implantables). If you do not have that information organised, open a spreadsheet and start recording it.
- If you have never received a safety notice from a manufacturer, consider asking your suppliers to confirm in writing what their communication channel is for these alerts.
Traceability is not just paperwork. It is what lets you sleep soundly when the manufacturer calls with a batch number and you know exactly where that product went.
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Sources
- Regulation (EU) 2017/745, Articles 10.12, 14.4, 14.5, 25 and 87.8 — publications.europa.eu
- Real Decreto 192/2023 — boe.es
- EUDAMED — health.ec.europa.eu
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