UK and EU End Users Are Not Importers

Generally speaking, end users are not considered to be importers.  This is the same for the UK and the MDD/MDR alike.  For example, the European Commission’s Directorate-General (DG) for Health and Food Safety advised me of that interpretation regarding the MDR, specifically saying, in part, that in both Regulations [(EU) 2017/745 (Article 2(33)) and (EU) 2017/746 (Article 2(26)], “importer” is defined as “any natural or legal person established within the Union that places a device from a third country on the Union market”.  And therefore that, if a manufacturer established outside the EU places a device on the EU market directly to a user, in such a case there is no importer, as there is no person established within the Union placing a device from a third country.

For the UK, end users don’t generally meet the UK regulations’ trigger for “supply” or placing on the market.  If instead the end user places the devices on the market or makes them further available on the market, then UK MDR regulatory obligations would ensue.  As long as the end user only uses the devices for their own particular end use, then they aren’t supplying or placing the devices on the market.

Declarations of Conformity: U.S. FDA vs. Europe

I received a question wondering whether the U.S. FDA mandates Declarations of Conformity (DoC) in the way Europe does, and whether U.S. and EU DoC can be combined into a single document.

In short, no, the US FDA doesn’t, as a general rule, require us to have a DoC in the way of the EU.  But the U.S. FDA does allow the voluntary use of a DoC in certain situations.  For example, in those situations where a 510(k) both a) relies on a voluntary/mandatory consensus standard; and b) the device conforms to all of the requirements of the applied consensus standard.  In other words, if there is any deviation in conformity with the applied consensus standard, then a DoC is not allowed by the FDA.

At one time, such declarations were generally limited to an “Abbreviated 510(k)”.  But nowadays, the way standards are used in Traditional 510(k)s vs. Abbreviated 510(k)s has, in my opinion, become basically the same.

Further evidence of the voluntary nature of such DoCs for the FDA is that FDA may alternatively accept what the agency calls “general use” of consensus standards.  “General use” means situations where the Sponsor decides to apply a consensus standard, yet does not submit a DoC.  Such use could involve either full conformity or partial conformity with the applied standard.

In contrast, every EU MDR / IVDR conformity assessment (except special scenarios like custom-made devices, investigational devices, Article 22 products, etc.) shall include a DoC drawn up in accordance with those European Regulations.

Now, since the aforesaid U.S. DoCs and EU DoCs are both generally modeled after ISO 17050-1 / EN ISO 17050-1 as amended, it certainly wouldn’t be hard to draw up a hybrid DoC that covers both jurisdictions.  But my personal preference is to not mix such declarations.  This is for document succinctness, easier revision control, and to avoid convolution between Europe’s “EN” standards compared to the non-EN versions recognized by the U.S., and also because the basic legislative/statutory reasons/uses of DoCs in the U.S. are fundamentally different than their use for the EU.

And to be sure I haven’t confused anyone, here are a few other clarifying points to consider:

I think that most everyone knows that Annex IV of the EU MDR and IVDR prescribes the exact requirements for an EU MDR/IVDR DoC.  But this post isn’t about how to do an EU MDR/IVDR DoC, nor about what are the precise elements of an EU MDR/IVDR DoC.  Instead, the question at hand is about combining a US DoC with an EU DoC.  Accordingly, for such comparative purposes (U.S. vs. EU), it is, for two reasons, quite germane that an EU MDR/IVDR DoC, is fundamentally modeled after (not the same as; yet modeled after) EN ISO 17050-1.  Specifically:

a) EN ISO 17050-1 is the traditional basis that gave rise to EU MDR/IVDR Annex IV.  For example, the Blue Guide reminds us of that when it states, “…The standard EN ISO/IEC 17050-1 has been drawn up with the objective of providing the general criteria for the declaration of conformity…”. Prior to EU MDR/IVDR Annex IV’s prescription, notified body’s used EN ISO 17050-1 as the basis for auditing MDD DoCs.

b) The U.S. FDA’s stated policy is that, “…To certify conformance with a consensus standard, the submitter must submit a DOC…These elements of a DOC are consistent with ISO/IEC 17050-1…”.

On a related note, I’ve also seen some folks use ‘Declaration of Conformity’ in reference to showing that a product has been inspected and shown to meet device acceptance criteria.  But my experience is that such a document is instead called a Certificate of Conformity (CoC), or Certificate of Analysis (CoA), or something similar.  I’ve not heard of, or seen, such a document being called a ‘Declaration of Conformity’.  To avoid confusion with the more proper conventional and legislative use of ‘Declaration of Conformity’, I would recommend against using ‘Declaration of Conformity’ as the name for a CoC/CoA.

eIFU MDD & EU MDR Notified Body is Required (as applicable)

Both Regulation (EU) 207/2012 (the eIFU regulation for the MDD) and Regulation (EU) 2021/2226 (the eIFU regulation for the EU MDR) require that conformity with those regulations be reviewed by a European notified body where applicable (i.e., for those device classes/types requiring notified body involvement for conformity assessment).

Can multiple different devices be on a single EU MDD/MDR DoC?

For a Declaration of Conformity (DoC) to a European Directive like 93/42/EEC on medical devices or to a European Regulation such as 2017/745 on medical devices, multiple different devices may indeed be encompassed by a single DOC. The Blue Guide reminds us that a single declaration of conformity can be made up of a dossier containing relevant individual declarations of conformity.  As long as all the required fundamental DOC contents/elements (e.g., per Annex IV of 2017/745, per Europe’s common framework for marketing of products, per EN ISO/IEC 17050-1 as amended, etc.) are clearly distinguished for each subject device, then a DoC including multiple devices should be good to go.

Standards Aren’t Required, but are Recommended, to Show European Conformity

You may have heard a rumor that conformity with harmonized standards or other non-harmonized standards is mandatory when showing conformity with the IVDD, MDD, IVDR, or MDR.  But that is not the intent of these European Directives and Regulations.  Instead, Europe fundamentally intends that conformity with harmonized standards, and even non-harmonized standards, shall remain voluntary unless such standards happen to also represent the generally recognized state-of-the-art, or unless application of a harmonized standard is in fact mandated, such as regarding the use of symbols in the information supplied with the device.

A couple examples (of many that could be given) proving this, is where the European Commission officially [see Regulation (EU) No. 1025/2012] states that:

• “…The primary objective of standardisation is the definition of voluntary technical or quality specifications…”

• “…European standardisation…is founded on the principles recognised by the World Trade Organisation (WTO) in the field of standardisation, namely…voluntary application, independence from special interests…” [emphasis added]

If you attempt to implement a policy demanding conformity with harmonized standards, or even un-harmonized standards, then, not only would you be in contravention of European legislation, but there is also a high probability that you will fail, and/or be subject to costly nonconformities, along with delayed market entry.

The ultimate conformity assessment mandate of the IVDD, MDD, IVDR, or MDR is that the “state-of-the-art” be suitably considered, and that we keep a record of whatever conformity solution happens to be applied, be it a standard (harmonized, un-harmonized European, or international), a Common [Technical] Specification (in the context of the IVDD, IVDR and MDR), or other solution [such as internally-derived specifications, international recognized publications, historical data, best medical practice, generally acknowledged state of the art (GASOTA), etc.].

Here are a few real-world examples that can quickly be a snare for you if you get too focused on harmonized or other standards:

• There are, and have historically been, harmonized standards that no longer represent the state-of-the-art and that, consequently, are generally inappropriate for use to demonstrate conformity.

• If there are any applicable Common [Technical] Specifications (IVDD/IVDR/MDR context), then those are mandatory, and generally trump a related standard.

• There are certain conformity assessment requirements for which no standard will exist at all.  For example, when demonstrating proper performance of a novel medical device whose technology is truly unprecedented.

• It is not uncommon that it is simply best medical practice that dictates what is deemed to be conformity and what is not.  I’ve had instances where certain local or international clinical standards of care or medical practice governed the device’s performance criteria and/or acceptability to the user.

It is true that if there is in fact a standard on which you and the notified body can agree, then that tends to help streamline the conformity assessment process.  But don’t paint yourself into an unrealistic corner by instituting a conformity assessment policy that sounds great in the classroom and looks good on paper, but that doesn’t give you sufficient flexibility for developing medical devices and implementing regulatory compliance in the real-world.

EU MDD and MDR “AFAP”

Check Your Existing Procedures:

Align Your Procedures:

A quick final note:  Risk management is not risk analysis (though risk management certainly includes risk analysis).  Accordingly, in order to comply with EN ISO 14971 and the EU MDR, it is necessary to have a Risk “Management” procedure that properly defines and integrates risk “analysis”.