September 28, 2021

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• There are, and have historically been, harmonized standards that no longer represent the state-of-the-art and that, consequently, are generally inappropriate for use to demonstrate conformity.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