You sell medical devices under your own brand or are thinking about doing so. Someone told you that makes you a manufacturer, and that word sounds like more obligations than you currently have. It's a reasonable assumption: if the product bears your name, you are responsible for what is sold under that brand.
Let's look at exactly what Regulation (EU) 2017/745 says about these cases, what situations trigger this change of role, and what you can do to avoid being caught off guard.
What does the MDR say a manufacturer is?
According to Article 2, point 30 of Regulation (EU) 2017/745, a manufacturer is anyone who manufactures or fully refurbishes a product, or has it designed, manufactured, or fully refurbished, and markets it under its own trade name or trademark.
This is the first thing you need to be clear about: if the product bears your name or brand, the Regulation treats you as the manufacturer, even if you haven't physically touched the product. You don't need to have a factory; it is enough that someone produced it and you place it on the market with your identification.
You can check how CE marking works and what you need to verify before selling any product in CE marking on medical devices: what it certifies and what you need to check yourself.
The three cases that change your role
Article 16.1 of the MDR establishes three specific situations in which a distributor or importer assumes the obligations of a manufacturer. This is not an open-ended list or a broad interpretation: these are exactly three cases.
The first case is the most common: marketing a product under your own name or brand. You put your label, your brand on the box, and the product is no longer the original manufacturer's for the purposes of the Regulation. You are the manufacturer in the eyes of the law.
The second case occurs when you change the intended purpose of a product already on the market. We are not talking about a minor adjustment of use, but a change of indication. For example, if you take a product registered for use in dental clinics and decide to sell it as a general consumer product, you have changed its intended purpose.
The third case is if you modify the product in a way that may affect compliance with the applicable requirements. This includes changes to the design, materials, manufacturing process, or specifications. Such a modification makes you responsible for verifying that the product remains compliant.
The exception: the written agreement with the manufacturer
There is a way to use your brand without becoming a manufacturer. Article 16.1 expressly states that you will not be considered a manufacturer if there is an agreement whereby the original manufacturer appears as such on the label and remains responsible under the MDR.
In practice, this means that the label shows the name of the manufacturer who actually manufactured or designed the product, not yours. You distribute, but the legal identification of the product points to the manufacturer. This agreement must be documented and available in case the authorities request it.
This is useful for white-label strategies where the distributor wants its commercial identity but does not want to assume the full regulatory structure of a manufacturer. The cost of this agreement is that the original manufacturer retains its obligations, and you rely on it to fulfil them correctly.
You can read more about what checks a distributor must carry out in Does your pharmacy distribute medical devices? Article 14 applies to you (almost certainly).
The manufacturer obligations you inherit
If none of the exceptions apply and you take on the role of manufacturer, here is what ends up on your list:
Article 10 of the MDR requires you to prepare and keep up to date the technical documentation for the product. This includes specifications, clinical evaluation studies where applicable, risk management, and post-market surveillance procedures.
You must have a quality management system proportionate to the risk class of the product, according to Article 10. This system must cover, among other aspects, the assignment of the unique UDI identifier, post-market surveillance, and the reporting of serious incidents to the competent authority.
Speaking of incident reporting, Article 87 sets specific timeframes: 15 days for serious incidents, reduced to 10 days if there is death or serious deterioration of health, and to just 2 days if there is a serious threat to public health.
Article 10.8 requires you to keep the technical documentation, the EU declaration of conformity, and the certificates for at least 10 years after the product is placed on the market. If the product is implantable, the period increases to 15 years.
Regarding the person responsible for regulatory compliance, Article 15 requires the manufacturer to have at least one person who can demonstrate university education in a relevant field and professional experience in regulatory affairs or quality management systems. Micro and small enterprises are not required to have this person within their organisation, but must be able to avail of them permanently and continuously.
You are not a manufacturer if you only assemble or adapt for a patient
Article 16.1 includes an important clarification: a person who assembles or adapts for a specific patient a product already placed on the market is not considered a manufacturer, provided this does not change its intended purpose.
This means that if you are an orthopaedic supplier and you adapt custom insoles, adjust a orthosis to a customer's measurements, or assemble crutches to the correct height for a specific person, you do not become a manufacturer. You are facilitating the personalised use of a product that already complies with the regulation.
The difference from the cases above is clear: here there is no change of brand, no change of intended purpose, and no modification of the product affecting its compliance. There is an individualised adaptation that does not transform the product itself.
What to do this week
- Review your catalogue and identify which products you sell under your own brand or trade name. If any come with the original manufacturer's label, locate the written agreement that makes it the manufacturer.
- If you have changed the intended purpose of any product or modified it in a way that may affect its compliance, assess whether you are assuming manufacturer obligations you didn't know you had.
- If you have determined that you are a manufacturer for any product, verify that you have up-to-date technical documentation, a quality management system for your risk class, and that you know the incident reporting timeframes in Article 87.
- Ask your supplier whether a white-label agreement is available that protects your commercial identity without making you liable as a manufacturer. If it does not exist, consider the implications before deciding.
The MDR does not punish the commercial ambition to brand your products, but it does require that whoever puts their name forward assumes the corresponding responsibility. Knowing your role before an inspection arrives is the difference between a professional conversation and a problem.
Quick questions
Q: If I just stick my pharmacy's name on the product, am I already a manufacturer?
A: Yes, the MDR considers anyone who markets under their own name or brand to be a manufacturer, even if they did not manufacture the product. Putting your brand on it places you in the position of manufacturer.
Q: Can I use my brand and have the original manufacturer remain the legal manufacturer?
A: Yes, but only if there is a documented agreement by which the manufacturer appears as such on the label. Without that written agreement, you assume the role even if you do not want to.
Q: I run a small orthopaedic shop and adapt products to measure. Does that make me a manufacturer?
A: No, provided you adapt or assemble for a specific patient without changing the product's intended purpose. Article 16.1 expressly specifies this.
Q: If I become a manufacturer, how long do I have to keep the technical documentation?
A: At least 10 years from the date the last product was placed on the market. If it is an implantable product, the period increases to 15 years, according to Article 10.8.