Good comments Richard. For readers' additional edification, I'll echo those and some of our prior posts on harmonized standards vs. state-of-the-art (for example, https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=4e7dca96-fbd0-4c51-b7b5-a10616a7e860&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer&cmd=rate&cmdarg=add#bm4e7dca96-fbd0-4c51-b7b5-a10616a7e860 ).
Specifically, application of harmonized standards is not, in and of itself, mandatory unless the harmonized standard happens to also be the state-of-the-art. Pursuant to MDD Article 5 and EU MDR Article 8, it is voluntary to use harmonized standards. In other words, if the manufacturer can achieve conformity by using alternatives and without full compliance to a harmonized standard, then MDD Article 5 / MDR Article 8 require the Notified Body (NB) to consider such a conformity approach. That said, most folks have traditionally elected to use the voluntary harmonized standard approach in order to realize easier consensus with the NB.
But ultimately, the weight and utility of a harmonized standard is always trumped by the state-of-the-art rule. Specifically, per MDD Annex I Section 2 and EU MDR Annex I Sections 1 and 4, conformity with the state-of-the-art is always required regardless of whether the state-of-the-art is or isn't a harmonized standard. As mentioned in my prior post, I recently saw this principle in action when I had a well-known NB require compliance with the latest version of an EN standard rather than the harmonized version.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
www.complianceacuity.comNote that I'm now far older and even uglier than in the photo above. Brace yourselves for my updated photo coming soon.
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 10-Feb-2020 04:24
From: Richard Vincins
Subject: EU MDR Harmonized Standards
Thanks for the post Kevin. I would also like to convey the European system is established around state of the art and even citing the good 'ole Good Manufacturing Practices (GMP). Individuals get too hung up on the term "harmonised standard" saying, 'well I do not need to follow it because it is not harmonised.' Which obviously is a wrong decision. If you read through the Directive and Regulation there are plenty of citations and interpretations for following start of the art when it comes to design and manufacturing. Just because the last version/year of a standard is not on a list somewhere does not preclude following the standard. In fact, when we are auditing one of the areas being checked now is how an organisation becomes aware of new regulations and standards ... then how these are assessed for impact on the QMS/product. The only regulatory agency doing a decent job keeping up with standards is the US FDA and even then sometimes there are a few weeks or months behind. When the EU comes up with a database that is relative currently, then I will start paying attention to these so called "harmonised standards" otherwise I will follow GMP and state of the art practices.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 08-Feb-2020 11:54
From: Kevin Randall
Subject: EU MDR Harmonized Standards
And to be clear, it is certainly most correct to acknowledge that no standards have yet, by way of corresponding references published in the OJEU, been officially harmonized for Regulation 2017/745. But for the purposes of Regulation 2017/745 conformity assessment efforts while awaiting OJEU publication of references to 93/42/EEC harmonized standards revised for use with Regulation 2017/745 (a process that will take a significant amount of time, most certainly extending beyond 26 May 2020), I'm leaning on Article 122 final paragraph to provide a bridge in the interim so that we are not left stranded without the practical purposes fundamentally intended by harmonized standardization.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
www.complianceacuity.com
Note that I'm now far older and even uglier than in the photo above. Brace yourselves for my updated photo coming soon.
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 07-Feb-2020 13:00
From: Kevin Randall
Subject: EU MDR Harmonized Standards
I think we should be very careful about asserting that there are no standards harmonized to Regulation 2017/745 (the EU MDR), or that the EU MDR will never have a harmonized standard. Reliance on harmonized standards is a deeply established and longstanding paradigm in Europe that extends beyond just the medical device sector. The notion that the EU MDR leaves us suddenly barren of harmonized standardization is a notion that is fundamentally contrary to Europe's wider legislative infrastructure.
Accordingly, be sure not to overlook the final paragraph of EU MDR Article 122 stating that references to the repealed Directives (i.e., 93/42/EEC and 90/385/EEC) shall be understood as references to the EU MDR and shall be read in accordance with the correlation table laid down in EU MDR Annex XVII. Although Annex XVII is far from perfect, and although it moreover will certainly leave some unanswered questions in areas where the EU MDR contains fundamentally new content with respect to Directives 93/42/EEC and 90/385/EEC, such a predicament is certainly far more manageable, and astronomically different, than the notion that we have no harmonized standardization at all under Regulation 2017/745.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
www.complianceacuity.com
Note that I'm now far older and uglier than in the photo above. Brace yourselves for my updated photo coming soon.
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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