With the adoption of European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulation for medical devices and in vitro medical devices has changed dramatically.
The main objectives of the 2017/745 European MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices and in vitro diagnostic medical devices that ensures a high level of safety and health, while supporting innovation.”
Art. 16 of the 2017/745 European MDR (Medical Device Regulation) is an article that was not contained in the previous MDD (Medical Device Directive).
In a way, Art.16 of the European Regulation 2017/745 MDR (Medical Device Regulation) comes full circle with respect to the figure of the manufacturer, which is one of the building blocks of the entire European Regulation 2017/745 MDR (Medical Device Regulation).
It is, therefore, absolutely permissible to delegate the manufacture of a medical device by a third party (such as, for example, using private label).
The element that qualifies the entity as a manufacturer, remembering that manufacturer is not the one who manufactures but the one who takes legal responsibility for the product, is that the entity ensures that that medical device complies with the regulation (e.g., CE Marking of the medical device).
The focus of the European regulation is not so much on the person who materially manufactures the medical device as it is on the person who comes to the market as the manufacturer, as he markets it by placing his name or trademark on it.
Art. 16 of the European Regulation 2017/745 MDR goes on to specify in Paragraph 1 what acts/operations, where performed on the medical device, transform the entity into a manufacturer; conversely, the following paragraphs 2-3-4 explain how the two activities of translating information for use and repackaging can be put in place without entailing the acquisition of the role of manufacturer, while complying with some specific requirements.
The person who makes the medical device available on the market by affixing its trade name to it, in the absence of an agreement with the manufacturer, assumes the obligations of the manufacturer.
This implies that the party who wants to affix its trade name can do so only after establishing a contractual agreement with the original manufacturer. It will also have to affix its own trademark without creating confusion about the role of the subjects.
There are, also, other illustrative cases such as:
If the person operating on the medical device changes the intended use or makes another type of change such that the safety requirements are compromised, he will acquire, in both cases, the role of the manufacturer.
Paragraph 1 of Art.16 dwells on another pivot point of the European regulation, which concerns adapters, a figure that does not find its own specific definition.
The standard says that the adapter is the person who assembles/adapts for a specific patient a medical device already on the market without changing the intended use. This is the case when a medical device is born as an adaptor.
The Manufacturer, in the risk analysis, must evaluate a subsequent operation of the medical device that will create adaptation. The person who performs the subsequent modification activity such as translation of the indications for use or repackaging while respecting the parameters of the risk analysis and the scope of the manufacturer’s certification, does not acquire the role of the manufacturer but retains the role of the adaptor.
Art.16 European Regulation 2017/745 MDR: The Comma 2-3-4
Paragraphs 2-3-4 of Article 16 of the European Regulation 2017/745 contain guidance regarding how to carry out the activities of translating directions for use or repackaging without acquiring the role of a manufacturer.
Two activities are very important: repackaging, an activity that is carried out in the context of parallel importation, and translation of the directions for use, an activity that can be carried out in the event that the person has to market the product in a new market and in the event that the directions for use are not in the language of the country of destination.
Paragraph 2 of Art.16 states that these activities are permissible without the acquisition of the manufacturer’s role as long as certain requirements are met. Specifically, Paragraph 3 of Art.16 stipulates that the modification activity performed on the medical device must be indicated either on the packaging and/or on a document. The person who will take/use the medical device must be aware that that product has undergone a modification (repackaged, translations of the directions for use into another language) and who, if any, has carried it out.
However, the European regulation requires a very important substantive fulfillment, namely, that the entity performing this activity implement a quality system.
Paragraph 4 of Art.16 stipulates that within 28 days of the distribution of the supply on the market, the manufacturer and the competent authority must be informed of the activity carried out, and a certification regarding the quality management system must be filed with the competent authority.
To recap: subsection 3 of Art.16 requires a quality system to be in place; subsection 4 of Art.16 requires certification to be filed with the competent authority.
However, the question immediately raised is:
“What must the distributor/importer/subject who wants to carry out repackaging or translation of directions for use do?”
“What are the requirements/processes/procedures that the notified body has to follow at the subject in order to be able to issue this particular certification?”
Medical Device Cordination Group Guideline 2021-23 states that the Notified Body for distributors/importers, should explain what both distributors/importers and the Notified Body are required to do.
Are you a manufacturer or distributor and don’t know how to submit an application for certification under MDR?
