A patient calls you: says their crutch broke and they fell over. A customer returns a thermometer because it gave an absurd reading. Someone contacts you from a residential home because a wheelchair caused a wound. What do you do, given that you are not the manufacturer?
Before getting into deadlines, the first thing is to know what we are assessing. Not every bad experience with a product is an incident under the Regulation. Article 2 of the MDR defines it precisely: a serious incident is one that could have caused or has caused, directly or indirectly, the death of a patient, user or other person, a serious — temporary or permanent — deterioration of their health, or a serious threat to public health. If the manufacturer has doubts about whether something is notifiable, the rule is clear: notify anyway within the deadline. They may submit an initial incomplete report first and then supplement the information.
Who notifies? The manufacturer, not the distributor
The obligation to notify the competent authority falls on the manufacturer. It is their legal responsibility under Article 87 of Regulation (EU) 2017/745. The distributor does not need to submit incident notifications to the AEMPS or any other competent authority. That role does not fall to them.
So, what does the distributor do when they receive a complaint of this kind? This is where Article 14(5) of the MDR comes in: the distributor must transmit immediately to the manufacturer (and, where applicable, to the authorised representative and the importer) any complaints or reports from healthcare professionals, patients or users about alleged incidents. Immediately means without delay. Not when you have a quiet moment, not at the end of the week. Article 13 imposes equivalent obligations on the importer along the same lines.
In addition, the distributor must keep a register of complaints, non-conforming products, and retrievals and recalls. It is an obligation to document, not to notify the authority.
Manufacturer deadlines by type of incident
If the manufacturer receives the information you have passed on to them — and you have passed it on without delay — the clock starts for them. Article 87 sets three deadlines from when the manufacturer becomes aware of the incident:
- 15 days, as a general rule.
- 10 days if the incident has caused death or a serious unforeseen deterioration of a person's health.
- 2 days if there is a serious threat to public health.
These are maximum deadlines. The manufacturer may submit an initial incomplete report first and then supplement the information.
Safety corrective actions: when does the manufacturer notify?
If the manufacturer decides to adopt a safety corrective action — a technical or medical measure to prevent or reduce the risk of a serious incident — they must notify the competent authority. According to Article 87(8), unless there is urgency, that notification must be made without undue delay and before taking the action. If the situation requires rapid action, notify without delay but the action may be carried out first. The user or customer receives the relevant information through a safety notice.
What if the manufacturer is not in Spain?
This is where the importer becomes relevant. The importer is, according to Article 2, point 33, the person established in the Union who places on the market a product coming from a third country. Article 13 of the MDR imposes obligations on them similar to those of the distributor: transmit the information to the manufacturer and keep their own register of complaints. If you sell products from outside the EU, you may be the importer without knowing it — our guide on being an importer without knowing it explains how to check.
What is not the distributor's responsibility?
It is not their role to verify whether an incident is serious or to classify it. They do not need to calculate deadlines or decide whether the competent authority should receive a notification. Their obligation is limited to three things: receive the information, pass it on to the manufacturer without delay, and keep a record of it in their register of complaints.
This ties in with what you must already comply with under Article 14(2) before placing any product on the market: checking that it bears the CE marking, that the EU declaration of conformity has been drawn up, that it is accompanied by the manufacturer's information in the required language, that the importer has indicated their details, and that the manufacturer has assigned a unique device identifier where applicable. If all of that was in order when you received the product, any subsequent incident is the manufacturer's responsibility.
What to do this week
- Check whether you have an up-to-date register of complaints. If you do not, open one. It does not need to be a sophisticated programme: a sheet with the date, product, batch number if known, description of the problem, and the person who reported it is enough to demonstrate that you act diligently.
- Locate now — not when there is a problem — the manufacturer's or their authorised representative's contact details for each product you distribute. You need to know who to send the information to if something occurs.
- If you sell products from outside the EU, identify who acts as the importer in the chain. It may be you without your knowing it.
The key point is simple: you do not notify, but nor can you sit on your hands. Passing on and recording information is what is expected of you.
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If you want to explore the distributor's obligations before placing a product on the market, you have the guide on what Article 14 of the MDR says to the pharmacy and the article on the 6 documents an inspector asks a distributor of medical devices for.