ISO 13485:2016 (hereinafter "v2016") clause 4.2.3 (Medical Device File) is the updated v2016 content corresponding to ISO 13485:2003 clause 4.2.1, third paragraph. The basic requirements of that clause and File have customarily been interpreted to overlap with FDA's requirements for Device Master Records (DMR) as well as the requirements for European Union (EU) CE Mark Technical Documentation. For example, ISO 14969 (an ISO 13485:2003 guidance document, though withdrawn and not yet updated for v2016) directly states that this File corresponds in part with an FDA DMR or European Technical File. And as described later in this post, ISO 14969 is still a relevant guidance document to be applied.
With the addition of the v2016 4.2.3 requirement for the File to include a general description of the medical device and its intended use/purpose, the updated v2016 requirements now have additional overlap with European CE mark Technical Documentation requirements. Such overlap is driven in part by v2016 4.2.3's requirement for the Medical Device File to contain or reference evidence of conformity with corresponding "applicable regulatory requirements". For example, if an ISO 13485:2016-registered manufacturer markets its non-GMP-exempt medical devices in the United States, then a DMR is an "applicable regulatory requirement" pursuant to FDA's 21 CFR 820.181. Similarly, if an ISO 13485:2016-registered manufacturer markets its European Class I sterile, I measuring, IIa, IIb, or III medical devices in the EU via the full quality assurance conformity assessment route, then a European Technical file is an applicable regulatory requirement pursuant to, for example, the European Medical Devices Directive (MDD) 93/42/EEC Annex II, Section 3.2(c).
As additional basis supporting these assertions, readers may also want to refer to Annex ZB of Europe's local version of v2016 (called "EN" ISO 13485:2016). Therein, Annex ZB directly correlates the v2016 Medical Device File with certain EC Technical Documentation requirements from MDD Annex II section 3.2(c). But what we also know from Annex ZB is that v2016 4.2.3 Medical Device File requirements don't perfectly overlap with the MDD's Technical Documentation requirements. Nor do they with FDA's 21 CFR 820.181. Therefore in practice, a fuller answer to Europe's Technical Documentation requirements can only be realized by application of v2016 4.2.3 combined with other v2016 clauses such as those for design and development files (v2016 clause 7.3.10). And the same dynamic exists regarding FDA's 21 CFR 820.181.
Also, remember that a reference to EN ISO 13485:2016 has not yet been published (unless I missed it) in the Official Journal of the EU. Per EU rules, this technically means that EN ISO 13485:2016 is not yet allowed to be used as a harmonized standard for the purposes of MDD Article 5. Consequently, EN ISO 13485:2012 [normatively equivalent to ISO 13485:2003 (which is why ISO 14969 is still relevant)] is still the official EU harmonized version of ISO 13485. That said, the Notified Bodies may give you a different feeling on the matter as they grapple with the difficult scheduling challenges of our current tsunami of regulatory changes.
Finally, note that in the v2016 clause 7.3.7 requirement for clinical evaluation (or other performance evaluations), we again see the new pervasive v2016 language about "applicable regulatory requirements". Therefore, if an ISO 13485:2016-registered manufacturer markets its medical devices in the EU, then MDD requirements such as Annex I (Chapter 1, Section 6a), or Annex II section 3.2(c), or Annex X, demand that the v2016 clause 7.3.7 clinical evaluation indeed be a full EU CER (i.e., per MEDDEV 2.7/1).
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.comCopyright 2017 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 23-Jul-2017 05:37
From: Rashmi Pillay
Subject: ISO 13485 :2016
Hi ,
Does anybody have an idea on :
4.2.3 Medical Device File : Assume this refers to the Device Master Record requirements (FDA terminology) and not the Technical file as required for CE marking.
7.3.7 Design development and validation and Clinical evaluation requirement - what exactly is the requirement here , does it refer to a complete CER as per MEDDEV 2.7/1 ?
Regards
Rashmi