Who are you according to the Medical Device Regulation?
The obligations for manufacturers, distributors, importers of medical devices
"Who am I, and if so, how many" asks Richard David Precht humorously in the title of his book on principle philosophical questions. From this year on, medical device companies will also have to ask themselves this question in detail because the Medical Device Regulation has now described their role(s) in the market more precisely than before. And with it, their obligations.
Few companies hold true to the statement that they are exclusively manufacturers of medical devices. More common is the combination of manufacturer and distributor, occasionally also importer.
How you define your role
Your role as a manufacturer of medical devices is relatively easy to define. Greatly simplified you manufacture medical devices or refurbish them as new and market them under your own name or your own brand.
If you now add some products that you don’t market under your name and which are from EU countries, then you are a distributor too. If these products are imported by you directly from a third country, then you are an importer. However, you can only import medical devices from the third country, if the manufacturer has an authorized representative within the EU.
You can see, how quickly it is for a manufacturer to take on two or three roles in the medical device market.
It is very important, that you are aware of the different roles you take on and you realize for which parts of your product portfolio you have which role. The MDR has clearly defined the obligations that come with each of these roles.
Which obligations you have according to the MDR
General manufacturer obligations are defined in article 10. Roughly saying, as a manufacturer you must ensure that the devices you place on the market conform to the requirements of the MDR. Among other things, you must implement a risk management system, establish and maintain a quality management system, apply the appropriate conformity assessment procedures, prepare the technical documentation as described and fulfill the registration obligations, etc.
General importer obligations are described in article 14. With a sampling procedure which is representative of the supplied products, the distributor should check whether the products are marked with a CE-label, whether a declaration of conformity has been issued, whether the information provided by the manufacturer is enclosed and, if necessary, whether a UDI has been assigned.
In Article 13, general obligations of importers are listed. In addition to similar checks, as described for distributors, and reporting obligations to manufacturers and authorities, importers have additional obligations to register and label products.
Article 11 of the Regulations deals with the authorized representative and his responsibilities. In addition to the tasks that the authorized representative must at least perform, the basic requirements for the mandate are also set out here. In addition to that, the liability of the authorized representative is also described in more detail.
Caution: When do the manufacturer obligations apply to distributor or importers?
As a manufacturer, you have many obligations and responsibilities. This is accompanied not only by extensive obligations for documentation or registration, but also for protection against claims arising from liability. As it is described at the beginning, it is therefore important that you are aware of your role as an economic operator for the individual components of your product portfolio.
In Article 16 the activities are described, that result in the obligations of a manufacturer also applying to you, if you are “only” a distributor or importer. Therefore, check your portfolio carefully to see if these criteria apply to you. Some activities, such as translating instruction manuals into the national language, don’t automatically lead to you having to comply with the manufacturer’s obligations, but again create new requirements for your quality management system and additional labeling obligations. Therefore, it may be necessary to create new processes here or to describe the existing ones.
Stop and refelct!
Get a detailed overview of your existing product portfolio, both the one you manufacture and the one you distribute. Clarify for each product what your role is as an economic operator. If you are not acting as a manufacturer, then check, if you still must assume the manufacturer’s obligations – based on the criteria in Article 16 – or which obligations you will have to fulfill in the future as a distributor or importer of these products.