MDR Article 16 MDR certificates for Importers and Distributors who translate IFU/labeling or rebox medical devices

Keith Morel, PHD

Did you know that as an importer or distributor who translates labeling or reboxes (non-sterile) medical devices that (a) it is mandated you have a QMS and (b) you need to have an “MDR Art. 16 certificate” for such activities (which is NOT an ISO 13485/9001 certificate or a CE certificate)?

Many relevant Economic Operators seem to have missed this requirement hidden in Article 16 of the MDR.

Let’s re-cap. Clearly, IF an importer/distributor markets a device under their own name (i.e. next to the little black factory EU harmonized symbol for legal manufacturer or similar) OR changes the intended purpose of a device already placed on the market (PoM) or Put in Service (PiS) OR "modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected" (and what that means precisely is open to interpretation), THEN like it or not THEY ARE the legal manufacturer in the EU and have to meet appropriate conformity assessment (i.e. QMS, TD, CER, DoC etc) which often will include having a CE cert issued by a NB [Art 16.1 MDR]

But part 2 of Article 16 tells us that they are NOT the (legal) manufacturer IF they:

a) translate the IFU/labeling of a device already PoM OR

b) if they REBOX a non-sterile product (doing that for a sterile product IS deemed to “[modify] a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected” and hence they would become the legal manufacturer per Art 16.1).

If they translate/rebox then they have to:

  1. identify that they do that on the label (and there are new symbols for that very purpose - translation and reboxing - in ISO 15223-1. [Art 16.3], and
  2. they MUST have a QMS that covers translation/reboxing. [Art 16.3]. Note this is the one place in the MDR where it MANDATES an importer/distributor have a QMS.

At least 28 days before they place such translated/reboxed devices on the market, they have to tell the competent authorities where they will PoM/PiS and the legal manufacturer they will do this and (if requested) "shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use." [Art 16.4].

They ALSO have to provide the CA with "a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3"

… et voila, this new certificate, an MDR Art 16 certificate!

What is the purpose of Article 16?

Partly Article 16 is concerned with transparency, a key pillar of the MDR. It is making plain who the legal manufacturer is in all cases (and avoids the lack of transparency that used to be present under the old Own Brand Labeling/Private Label situations of the past) and when translation/reboxing is being carried out (in an EU market) by those other than the manufacturer, clearly identifying who they are.

There could also be an aspect of free trade to it too. Some commentators have noted that allowing importers and distributors to translate/rebox may prevents the manufacturer from controlling a market by providing the labeling/IFU in the locally required languages in a particular country and perhaps charging a higher price than in other countries; under Art 16.2, importers/distributors would be allowed to provide translations/different (non-sterile) box configurations and charge different prices than the manufacturer potentially, thereby letting local market forces determine a fair price.   

To be continued…


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