Regulatory Open Forum

When deliberating about the type and extent of required Importer or Distributor product verification under EU MDR Articles 13 and 14, it is necessary to apply a risk-based approach, as the EU MDR doesn't directly prescribe the type or extent of such verification.  Instead, the EU MDR (directly and by way of integrating Europe's "common framework" for marketing of medical devices) requires that importers and distributors "act with due care" in relation to the requirements applicable when placing or making products available on the market.

Noteworthy is that Europe's common framework requires, when deemed appropriate with regard to the risks presented by a product, that Importers shall, to protect the health and safety of consumers, carry out "sample testing" of marketed products.  Regarding such sample testing (if needed at all), then I would recommend applying, commensurate with risk, an appropriate statistically-based sampling plan.  At the risk of starting a riot regarding what is the best statistically-based sampling plan, especially in the context of Europe and harmonized standards / state of the art, I might refer you to ISO 2859-1.

The particular type of verification/testing, as with the extent, needs to be established commensurate with risk.  For lower-risk scenarios, it may be sufficient to simply have contractual assurance that the products will contain the required labeling.  Higher up the risk scale, images of DHRs may be needed or sufficient.  For high-risk devices, it may indeed be appropriate for the Importer to, on a sampling basis, open packages and confirm the presence of proper labeling.  In such a case, if destruction of the sampled product is not acceptable (consequently requiring the Importer to repackage the device), then it is important to be aware that the Importer might in so doing exceed the manufacturing thresholds of EU MDR Article 16, in particular, paragraph 1 point (c) thereof.  Note that Article 16 paragraph 2 point (b) (yet in a slightly different context) provides some liberty for Importers to perform repackaging operations without triggering the manufacturing threshold.  Accordingly, the basic notion of such an Importer operation is not generally out of the ordinary.  But I would nonetheless strongly recommend that such repackaging operations be performed in accordance with a repackaging instruction approved in advance by the Manufacturer.  I'll save for another time, or for others in the Forum, the discussion of whether such repackaging constitutes "rework".

When deliberating about the type and extent of required Importer or Distributor product verification under EU MDR Articles 13 and 14, it is necessary to apply a risk-based approach, as the EU MDR doesn't directly prescribe the type or extent of such verification.  Instead, the EU MDR (directly and by way of integrating Europe's "common framework" for marketing of medical devices) requires that importers and distributors "act with due care" in relation to the requirements applicable when placing or making products available on the market.

Noteworthy is that Europe's common framework requires, when deemed appropriate with regard to the risks presented by a product, that Importers shall, to protect the health and safety of consumers, carry out "sample testing" of marketed products.  Regarding such sample testing (if needed at all), then I would recommend applying, commensurate with risk, an appropriate statistically-based sampling plan.  At the risk of starting a riot regarding what is the best statistically-based sampling plan, especially in the context of Europe and harmonized standards / state of the art, I might refer you to ISO 2859-1.

The particular type of verification/testing, as with the extent, needs to be established commensurate with risk.  For lower-risk scenarios, it may be sufficient to simply have contractual assurance that the products will contain the required labeling.  Higher up the risk scale, images of DHRs may be needed or sufficient.  For high-risk devices, it may indeed be appropriate for the Importer to, on a sampling basis, open packages and confirm the presence of proper labeling.  In such a case, if destruction of the sampled product is not acceptable (consequently requiring the Importer to repackage the device), then it is important to be aware that the Importer might in so doing exceed the manufacturing thresholds of EU MDR Article 16, in particular, paragraph 1 point (c) thereof.  Note that Article 16 paragraph 2 point (b) (yet in a slightly different context) provides some liberty for Importers to perform repackaging operations without triggering the manufacturing threshold.  Accordingly, the basic notion of such an Importer operation is not generally out of the ordinary.  But I would nonetheless strongly recommend that such repackaging operations be performed in accordance with a repackaging instruction approved in advance by the Manufacturer.  I'll save for another time, or for others in the Forum, the discussion of whether such repackaging constitutes "rework".

Peter, when approaching the obligations of Importers and Distributors under EU MDR Articles 13 and 14, I think it is important to remember that, as described in my initial post, both Distributors and Importers are expected by the EU MDR to "act with due care" in relation to the requirements applicable when placing or making products available on the market.  And both Distributors and Importers commensurate with risk, are expected by the EU MDR to perform sample testing (i.e., verification).  Read on to see the legislative basis for both of these assertions.

It is indeed odd that EU MDR Article 14 (for Distributors) directly states the requirement to "act with due care", while in contrast, the EU MDR (and thus Article 13 for Importers) only incorporates that longstanding Importer expectation by reference (see EU MDR preface objective #25) to Parliament / Council Decision 768/2008 on the common framework for marketing of products (i.e., "the common framework" mentioned in my initial post).  That Decision requires Importers to make sure that products (e.g., medical devices) comply with applicable Community legislation (e.g., Regulation 2017/745) and requires that, "Both importers and distributors are expected to act in due care" [emphasis added] in this regard (see that Decision's preface objectives #20 and 23).

I will say that, although preface objective #6 of the aforesaid Decision allows legislators to justifiably depart from that Decision's principles and provisions, I also note that preface objective #7 includes a reminder of legislators' political commitment to, and the need to, respect that Decision when promulgating new legislation (e.g., Regulation 2017/745) falling within the scope of that Decision.

Moreover, in general, it would not seem reasonable to exempt Importers from taking the due care expected by the Parliament / Council Decision.  And I know of no EU MDR legislator justification for exemption of the aforesaid longstanding Importer requirements; perhaps the Forum can provide further insight on that.  Until then, it seems that these longstanding Importer safeguards have not been undone by the EU MDR's clerical approach of integrating by reference the longstanding importer obligations of Parliament/Council Decision 768/2008.

The same exact rationale applies regarding importer sampling of products.  Specifically, Parliament/Council Decision 768/2008 mandates that Importers shall, "…when deemed appropriate with regard to the risks presented by a product…carry out sample testing of marketed products…" [emphasis added].  Accordingly, I would advise not to dismiss or overlook this longstanding Importer obligation, especially in the context of the intrinsic risks posed by medical devices.

Based on the aforesaid longstanding Importer sampling requirement, and as shown by my initial post, I would strongly advise against the notion that Importers are to perform testing for each device unit placed on the market. Again, as per my initial post, the extent of verification needs to be established commensurate with risk.  For lower-risk scenarios, it may be sufficient to simply have contractual assurance that the products will contain the required labeling.  Higher up the risk scale, images of DHRs may be needed or sufficient.  For high-risk devices, it may indeed be appropriate for the Importer to, on a sampling basis, open packages and confirm the presence of proper labeling.

On the other hand, I do not agree that Importers only need to perform verification on a sample of the various "type of" devices the Importer places on the market.  That approach would seem to guarantee that the importer would not be acting with "…due care…" commensurate with risk "…to protect the health and safety of consumers…" [emphasis added to Decision 768/2008].  For example (to name just one of many), if an Importer only performed conformity assessment verification on the pacemakers imported from Manufacturer A but not also on the pacemakers imported from Manufacturers B, C, etc., then the fundamental intent of the aforesaid checks and balances would certainly go unmet.  And I would contend that this remains the same even for lower risk devices.  In other words, for all risk classes, I'm suggesting that the Importer needs to perform the required checks and balances (i.e., verifications) for all of the device types imported from all of the Importer's source Manufacturers.  As hinted at in my initial post, such Importer verification may, in its simplest form, be nothing more than corresponding contractual arrangements executed between the Importer and Manufacturer.

Like Peter, I welcome other Forum Members' insights on these matters.

When deliberating about the type and extent of required Importer or Distributor product verification under EU MDR Articles 13 and 14, it is necessary to apply a risk-based approach, as the EU MDR doesn't directly prescribe the type or extent of such verification.  Instead, the EU MDR (directly and by way of integrating Europe's "common framework" for marketing of medical devices) requires that importers and distributors "act with due care" in relation to the requirements applicable when placing or making products available on the market.

Noteworthy is that Europe's common framework requires, when deemed appropriate with regard to the risks presented by a product, that Importers shall, to protect the health and safety of consumers, carry out "sample testing" of marketed products.  Regarding such sample testing (if needed at all), then I would recommend applying, commensurate with risk, an appropriate statistically-based sampling plan.  At the risk of starting a riot regarding what is the best statistically-based sampling plan, especially in the context of Europe and harmonized standards / state of the art, I might refer you to ISO 2859-1.

The particular type of verification/testing, as with the extent, needs to be established commensurate with risk.  For lower-risk scenarios, it may be sufficient to simply have contractual assurance that the products will contain the required labeling.  Higher up the risk scale, images of DHRs may be needed or sufficient.  For high-risk devices, it may indeed be appropriate for the Importer to, on a sampling basis, open packages and confirm the presence of proper labeling.  In such a case, if destruction of the sampled product is not acceptable (consequently requiring the Importer to repackage the device), then it is important to be aware that the Importer might in so doing exceed the manufacturing thresholds of EU MDR Article 16, in particular, paragraph 1 point (c) thereof.  Note that Article 16 paragraph 2 point (b) (yet in a slightly different context) provides some liberty for Importers to perform repackaging operations without triggering the manufacturing threshold.  Accordingly, the basic notion of such an Importer operation is not generally out of the ordinary.  But I would nonetheless strongly recommend that such repackaging operations be performed in accordance with a repackaging instruction approved in advance by the Manufacturer.  I'll save for another time, or for others in the Forum, the discussion of whether such repackaging constitutes "rework".