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 standarisation 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- There are, and have historically been, harmonized standards that no longer represent the state-of-the-art and that, consequently, are generally inappropriate for use to demonstrate conformity.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.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 28-Sep-2021 17:33
From: Dan O'Leary
Subject: Standards listed in Essential Requirements/GSPR
You will demonstrate that your device meets the applicable essential requirements by using a standard. The checklist should cite the full identification of the standard which include the issuing organization, and the version. You should also cite the clauses that apply to the specific requirement. Then, follow the requirement of the clauses and produce the objective evidence to show conformity.
Select the standards in order:
Harmonized EN standard
Non-harmonized EN standard
International standard (such as ISO or IEC)
National standard
One question is the role of standards organization as national or international. For example, ANSI used to be the American National Standards Institute so considered national standards. Now, they are more global, so probably fit into the international standard category.
In practice, use the best standard for the task giving preference to EN standards.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 28-Sep-2021 11:05
From: Anonymous Member
Subject: Standards listed in Essential Requirements/GSPR
This message was posted by a user wishing to remain anonymous
I am working on an IVDD technical file, of which my company has a template for the essential requirements. The template includes a list of example standards, which are not European harmonised standards. This is my first time preparing an essentail requirements checklist and am not clear on whether we should be including ANSI, ASTM, CLSI, ISTA, along with EN ISOs, ENs, or just regular ISOs.
Should I include these other non-EN standards or stick to the European harmonised standards. Unfortunately, no one in my team knows for sure and are curious about approach for IVDR as well.
Thanks!