I think it's practically imperative that the voluntary nature of standards be well understood (notwithstanding the mandatory requirement for use of some standards such as regarding symbols). And regarding "state of the art", believe it or not, the legislation doesn't actually require compliance with the state of the art. Instead, we must only "take into account" the general acknowledged state of the art. Indeed, as the MDCG reiterates, the EU MDR and the MDD call for the need to take into account the generally acknowledged state of the art to comply with the health, safety and performance requirements. However, the MDCG underlines that "taking into account" is different from "compliance", due to the fact that "state of the art" is not a legally defined concept and involves several complex aspects which are difficult to be expressed in a single and clear definition. So be leery about standardization mandates, even regarding state of the art standards.
Again, the use of standards, whether harmonized or any other standard (e.g., state of the art) in the medical device sector, has been for decades, and continues to be, voluntary. MDCG reiterates that the voluntary character of the use of standards means in practice that the manufacturer may always choose to apply the technical solutions provided by European harmonized standards or by non-harmonized European standards, or by any other international or national standards, or even to develop its own technical solutions, provided that it is able to demonstrate that these different or alternative non-harmonized means are adequate to comply with the legal requirements applicable to the product. MDCG emphasizes that choosing to use a standard or not belongs to the manufacturer, within its overall and ultimate responsibility on compliance. MDCG reminds us that a gap assessment isn't mandatory for this. It is not possible to impose the use of any specific standard, on the basis for instance of its status of harmonized European standard or of "state-of-the-art" standard, neither by national authorities in their market surveillance or vigilance activities, nor by notified bodies in the conformity assessment procedures they participate in. MDCG emphasizes that, to be lawfully placed on the EU market, medical devices must (see my preceding posts) comply with the health, safety and performance requirements of the applicable legislation, and not necessarily with the clauses of a standard.
Yet, in the commonplace event that a standard is chosen by a manufacturer as its means for demonstrating conformity with a GSPR(s), then I would prioritize my standards selection as follows in alignment with the MDCG:
- The most recent editions of standards published by the standards organization as reflecting state-of-the-art, regardless of European harmonization status.
- European harmonized version.
Indeed, I've had prominent notified bodies reject use of European harmonized standards that weren't the latest standard version from the standards organization.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 22-Mar-2023 10:15
From: Dan O'Leary
Subject: Use of non-harmonized standards to support conformity to specific GSPR
My clients have experienced similar situations, but not this one.
First, a little background.
Neither MDD nor MDR requires the use of harmonized standards.
Both MDD and MDR require the use of state-of-the-art standards. Often this was not an issue in MDD but has become significant in MDR.
For MDD, the harmonization process broke, and the harmonized standards were often years behind the state-of-the-art standards. The MDR process is a little better, but there are not many harmonized standards.
In satisfying the GS&PR you need the state-of-the-art standard. Your first choice should be a harmonized standard. Your second choice should be the current EN standard. Your third choice should be the current international standard (IEC, ISO, etc.)
If you used that same standard, including version, for the MDD and the MDR, it is likely that the standard is not state-of-the-art. The NB is asking for a gap analysis to demonstrate that, even though you did not use the state-of-the-art standard, the changes do not apply to your device.
In the most recent case, NB asked my client for a detailed list of the changes including an analysis of why they were not relevant. In addition, the NB wanted documentation of the competency of the person preparing the gap analysis. Because some of the items in the gap analysis should have been implemented in the device, the NB wanted an implementation plan and reports showing conformance.
The message is that state-of-the-art is important in MDR, and the NB will expect your company to implement the standards as they change. This comes from the strategy that the people in Europe have access to the best health care in the world.
Notice that this is not the FDA's expectation. Once a device is cleared, FDA does not expect it to incorporate changes from standards.
The bad news is that the MDR may result in design changes that subsequently require a 510(k) change on the FDA side.<o:p></o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 21-Mar-2023 11:44
From: Anonymous Member
Subject: Use of non-harmonized standards to support conformity to specific GSPR
This message was posted by a user wishing to remain anonymous
Dear colleagues,
I'd like to hear your opinion and experience regarding using non-harmonized standards to support compliance of your product to the EU MDR GSPR.
My class IIa device technical documentation (device intended for remote physiological parameters monitoring) has undergone the first round of technical documentation review.
One of the deficiencies my notified body noted is related to not submitting a GAP analysis for each of the non-harmonized standards used to support GSPR compliance.
What we included in the submission package is an analysis and a rationale of why a given non-harmonized standard was used to support a GSPR or a part of a GSPR. The notified body is asking to provide a GAP analysis between the 93/42/EEC Essential Requirements and the 2017/745 GSPR, including a GAP analysis between the harmonized standards under the MDD and the standard used in the current technical documentation.
Is this something standard, in your opinion? Did it happen to you in the past?
Any thoughts?
Thanks